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PT. KALBE FARMA TBK.

AUTO FREEZE DRYING Batch Report


Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section1:Overview

Catalog
No. Item Value
1 Section1 Section1:Overview
2 Section2 Section2:Freeze Drying Recipe
3 Section3 Section3:Operation Parameters
4 Section4 Section4:History trend

Machine Information
No. Item Value
1 Manufacturer Name IMA Life
2 Manufacturer Address 101 Wangjing LizeZhongYuan,Chaoyang,100102,Beijing,China
3 Web Site www.IMALife.com
4 Service Phone 86-10-64399688
5 Service Fax 86-10-64392556
6 Custom Name PT. KALBE FARMA TBK.

Batch Information
No. Item Value
1 Initiator Full Name SAHIDIN
2 Abortor Full Name
3 Product Name Pranza 40mg
4 Product Type Vial
5 Product Quantity 24840
6 Container Size 10
7 Container Quantity 24840
8 Container Fill Volume 3.1
9 Product Container Type Vial
10 Batch Name AFD20210603161402
11 Batch Series Number 1856
12 Batch Comments Pranza 40mg Injeksi Vial
13 Batch Description VPRZA10086
14 Batch Start Time 6/3/2021 16:14
15 Batch End Time 6/5/2021 10:38
16 Batch End Mode Normal
17 Report template name VIT_AFD

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Approved by Date Page: 1 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section2:Freeze Drying Recipe

Recipe Information
No. Item Value
1 Freeze Drying Recipe Name VPRZ1R
2 Freeze Drying Recipe Number 2030
3 Freeze Drying Recipe Description REDUCE TIME
4 Freeze Drying Recipe Comments PERUBAHAN WAKTU LIOFILISASI

General Parameters
No. Name High Limit Low Limit Value Unit
1 Control vacuum high deviation 1000 0 30 µBar
2 Control vacuum low deviation 1000 0 30 µBar
3 Control vacuum pre-alarm setpoint 1000 0 500 µBar
4 Control vacuum alarm setpoint 1000 0 600 µBar
5 Vacuum control gas selection - - Nitrogen -
6 Pre-aeration gas selection - - Nitrogen -

Step Parameters
Step
Step Step Vacuum Step Time
Step Name Temperature
No.
(°C) (µbar) HH:MM MM:SS
1 Loading 5 -- -- --
2 Freezing 5 -- 0 : 30 --
3 Freezing -45 -- 1 : 40 --
4 Freezing -45 -- 1 : 30 --
5 Evacuation -- 200 -- --
6 Drying 5 200 1 : 40 --
7 Drying 5 200 15 : 0 --
8 Drying 5 200 0:0 --
9 Drying 50 200 1 : 30 --
10 Drying 50 200 6:0 --
11 Moisture Test -- 10 -- 60 : 60
12 Pre-Aeration -- -- -- --
13 Stoppering -- -- -- 0 : 20
14 Aeration -- -- -- --
15 Storage 20 -- 15 : 0 --

The hour part of P.R.T time setpoint is test repeat time(minute),minute part is test time(second).

-------------------------------------------
Approved by Date Page: 2 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 16:12:00 2.9 5.0 41.2 40.9 - 30 80 0 700
6/3/2021 16:13:00 2.8 5.0 41.2 40.9 - 30 80 0 704
6/3/2021 16:13:40 Audit: - Manual shelf temperature regulation is disabled by IDIN.
6/3/2021 16:13:43 Audit: - Manual control mode is de-activated by IDIN.
6/3/2021 16:13:51 Audit: - Auto control mode is activated by IDIN.
6/3/2021 16:14:02 Audit: - The auto freeze drying is started by IDIN.
6/3/2021 16:16:26 Event: - Step advanced to [1] Loading
6/3/2021 16:16:28 Audit: - Slave panel is enabled by IDIN.
6/3/2021 16:17:00 5.7 5.0 41.0 40.6 - - 80 0 712
6/3/2021 16:18:00 4.6 5.0 40.9 40.5 - - 80 0 713
6/3/2021 16:19:00 5.5 5.0 40.9 40.5 - - 80 0 716
6/3/2021 16:20:00 4.6 5.0 40.8 40.5 - - 80 0 716
6/3/2021 16:21:00 5.4 5.0 40.8 40.4 - - 80 0 720
6/3/2021 16:22:00 4.5 5.0 40.7 40.4 - - 80 0 720
6/3/2021 16:23:00 5.4 5.0 40.7 40.3 - - 80 0 725
6/3/2021 16:24:00 4.6 5.0 40.7 40.3 - - 80 0 725
6/3/2021 16:25:00 5.3 5.0 40.6 40.3 - - 80 0 728
6/3/2021 16:26:00 4.5 5.0 40.6 40.2 - - 80 0 728
6/3/2021 16:27:00 5.3 5.0 40.6 40.2 - - 80 0 733
6/3/2021 16:28:00 4.7 5.0 40.5 40.1 - - 80 0 732
6/3/2021 16:29:00 5.3 5.0 40.5 40.1 - - 80 0 737
6/3/2021 16:30:00 4.7 5.0 40.4 40.1 - - 80 0 737
6/3/2021 16:31:00 5.3 5.0 40.4 40.0 - - 80 0 741
6/3/2021 16:32:00 4.6 5.0 40.4 40.0 - - 80 0 742
6/3/2021 16:33:00 5.3 5.0 40.3 40.0 - - 80 0 746
6/3/2021 16:34:00 5.0 5.0 40.3 39.9 - - 80 0 745
6/3/2021 16:35:00 5.3 5.0 40.2 39.9 - - 80 0 750

-------------------------------------------
Approved by Date Page: 3 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 16:36:00 4.7 5.0 40.2 39.8 - - 80 0 750
6/3/2021 16:37:00 5.3 5.0 40.2 39.8 - - 80 0 754
6/3/2021 16:38:00 4.6 5.0 40.1 39.7 - - 80 0 754
6/3/2021 16:39:00 5.1 5.0 40.1 39.7 - - 80 0 754
6/3/2021 16:40:00 4.8 5.0 40.1 39.7 - - 80 0 759
6/3/2021 16:41:00 5.2 5.0 40.0 39.7 - - 80 0 759
6/3/2021 16:42:00 4.4 5.0 40.0 39.6 - - 80 0 763
6/3/2021 16:43:00 5.3 5.0 39.9 39.6 - - 80 0 767
6/3/2021 16:44:00 4.6 5.0 39.9 39.5 - - 80 0 767
6/3/2021 16:45:00 5.3 5.0 39.9 39.5 - - 80 0 767
6/3/2021 16:46:00 5.0 5.0 39.8 39.5 - - 80 0 772
6/3/2021 16:47:00 5.3 5.0 39.8 39.4 - - 80 0 772
6/3/2021 16:48:00 4.6 5.0 39.7 39.4 - - 80 0 776
6/3/2021 16:49:00 5.1 5.0 39.7 39.3 - - 80 0 776
6/3/2021 16:50:00 4.4 5.0 39.6 39.3 - - 80 0 780
6/3/2021 16:51:00 5.3 5.0 39.6 39.2 - - 80 0 781
6/3/2021 16:52:00 5.0 5.0 39.6 39.2 - - 80 0 786
6/3/2021 16:53:00 5.3 5.0 39.5 39.2 - - 80 0 786
6/3/2021 16:54:00 4.9 5.0 39.5 39.1 - - 80 0 790
6/3/2021 16:55:00 5.2 5.0 39.5 39.1 - - 80 0 790
6/3/2021 16:56:00 4.6 5.0 39.4 39.0 - - 80 0 795
6/3/2021 16:57:00 5.3 5.0 39.4 39.0 - - 80 0 795
6/3/2021 16:58:00 4.9 5.0 39.3 39.0 - - 80 0 795
6/3/2021 16:59:00 5.3 5.0 39.3 38.9 - - 80 0 800
6/3/2021 17:00:00 4.9 5.0 39.3 38.9 - - 80 0 800
6/3/2021 17:01:00 5.3 5.0 39.2 38.8 - - 80 0 805
6/3/2021 17:02:00 4.5 5.0 39.2 38.8 - - 80 0 805

-------------------------------------------
Approved by Date Page: 4 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 17:03:00 5.1 5.0 39.1 38.7 - - 80 0 809
6/3/2021 17:04:00 4.5 5.0 39.1 38.7 - - 80 0 809
6/3/2021 17:05:00 5.3 5.0 39.0 38.7 - - 80 0 814
6/3/2021 17:06:00 4.9 5.0 39.0 38.6 - - 80 0 814
6/3/2021 17:07:00 5.3 5.0 39.0 38.6 - - 80 0 814
6/3/2021 17:08:00 4.6 5.0 39.0 38.6 - - 80 0 819
6/3/2021 17:09:00 5.3 5.0 38.9 38.5 - - 80 0 819
6/3/2021 17:10:00 5.1 5.0 38.8 38.5 - - 80 0 824
6/3/2021 17:11:00 5.3 5.0 38.8 38.5 - - 80 0 823
6/3/2021 17:12:00 4.5 5.0 38.7 38.4 - - 80 0 829
6/3/2021 17:13:00 5.3 5.0 38.7 38.4 - - 80 0 829
6/3/2021 17:14:00 4.9 5.0 38.7 38.3 - - 80 0 833
6/3/2021 17:15:00 5.2 5.0 38.6 38.3 - - 80 0 833
6/3/2021 17:16:00 4.5 5.0 38.6 38.2 - - 80 0 838
6/3/2021 17:17:00 5.3 5.0 38.6 38.2 - - 80 0 838
6/3/2021 17:18:00 4.9 5.0 38.5 38.2 - - 80 0 842
6/3/2021 17:19:00 5.2 5.0 38.5 38.1 - - 80 0 843
6/3/2021 17:20:00 4.5 5.0 38.5 38.1 - - 80 0 842
6/3/2021 17:21:00 5.3 5.0 38.4 38.1 - - 80 0 848
6/3/2021 17:22:00 4.5 5.0 38.4 38.0 - - 80 0 847
6/3/2021 17:23:00 5.3 5.0 38.4 38.0 - - 80 0 853
6/3/2021 17:24:00 5.0 5.0 38.3 37.9 - - 80 0 852
6/3/2021 17:25:00 5.2 5.0 38.2 37.9 - - 80 0 853
6/3/2021 17:26:00 4.5 5.0 38.2 37.9 - - 80 0 857
6/3/2021 17:27:00 5.3 5.0 38.2 37.8 - - 80 0 858
6/3/2021 17:28:00 5.1 5.0 38.2 37.8 - - 80 0 862
6/3/2021 17:29:00 5.3 5.0 38.1 37.7 - - 80 0 862

-------------------------------------------
Approved by Date Page: 5 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 17:30:00 4.9 5.0 38.1 37.7 - - 80 0 867
6/3/2021 17:31:00 5.3 5.0 38.0 37.7 - - 80 0 867
6/3/2021 17:32:00 4.8 5.0 38.0 37.6 - - 80 0 868
6/3/2021 17:33:00 5.2 5.0 38.0 37.6 - - 80 0 872
6/3/2021 17:34:00 4.9 5.0 37.9 37.6 - - 80 0 873
6/3/2021 17:35:00 5.2 5.0 37.9 37.5 - - 80 0 878
6/3/2021 17:36:00 4.8 5.0 37.8 37.5 - - 80 0 878
6/3/2021 17:37:00 5.2 5.0 37.8 37.4 - - 80 0 878
6/3/2021 17:38:00 4.9 5.0 37.8 37.4 - - 80 0 883
6/3/2021 17:39:00 5.2 5.0 37.7 37.3 - - 80 0 883
6/3/2021 17:40:00 4.7 5.0 37.7 37.3 - - 80 0 888
6/3/2021 17:41:00 5.2 5.0 37.7 37.3 - - 80 0 888
6/3/2021 17:42:00 4.8 5.0 37.6 37.2 - - 80 0 893
6/3/2021 17:43:00 5.2 5.0 37.6 37.2 - - 80 0 893
6/3/2021 17:44:00 4.9 5.0 37.5 37.2 - - 80 0 893
6/3/2021 17:45:00 5.2 5.0 37.5 37.1 - - 80 0 898
6/3/2021 17:46:00 4.8 5.0 37.5 37.1 - - 80 0 898
6/3/2021 17:47:00 5.2 5.0 37.4 37.1 - - 80 0 904
6/3/2021 17:48:00 4.9 5.0 37.4 37.0 - - 80 0 904
6/3/2021 17:49:00 5.2 5.0 37.3 37.0 - - 80 0 904
6/3/2021 17:50:00 4.7 5.0 37.3 36.9 - - 80 0 909
6/3/2021 17:51:00 5.2 5.0 37.3 36.9 - - 80 0 909
6/3/2021 17:52:00 4.8 5.0 37.2 36.8 - - 80 0 909
6/3/2021 17:53:00 5.2 5.0 37.2 36.8 - - 80 0 914
6/3/2021 17:54:00 4.9 5.0 37.1 36.8 - - 80 0 914
6/3/2021 17:55:00 5.2 5.0 37.1 36.8 - - 80 0 919
6/3/2021 17:56:00 4.9 5.0 37.1 36.7 - - 80 0 919

-------------------------------------------
Approved by Date Page: 6 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 17:57:00 5.2 5.0 37.0 36.7 - - 80 0 919
6/3/2021 17:58:00 4.8 5.0 37.0 36.6 - - 80 0 924
6/3/2021 17:59:00 5.2 5.0 37.0 36.6 - - 80 0 925
6/3/2021 18:00:00 4.9 5.0 36.9 36.6 - - 80 0 927
6/3/2021 18:01:00 5.2 5.0 36.8 36.5 - - 80 0 930
6/3/2021 18:02:00 4.9 5.0 36.8 36.5 - - 80 0 936
6/3/2021 18:03:00 5.2 5.0 36.8 36.4 - - 80 0 935
6/3/2021 18:04:00 4.8 5.0 36.8 36.4 - - 80 0 936
6/3/2021 18:05:00 5.2 5.0 36.7 36.4 - - 80 0 941
6/3/2021 18:06:00 4.9 5.0 36.7 36.3 - - 80 0 940
6/3/2021 18:07:00 5.2 5.0 36.6 36.3 - - 80 0 941
6/3/2021 18:08:00 4.9 5.0 36.6 36.3 - - 80 0 946
6/3/2021 18:09:00 5.2 5.0 36.6 36.2 - - 80 0 947
6/3/2021 18:10:00 4.8 5.0 36.6 36.2 - - 80 0 946
6/3/2021 18:11:00 5.2 5.0 36.6 36.1 - - 80 0 951
6/3/2021 18:12:00 4.8 5.0 36.5 36.1 - - 80 0 951
6/3/2021 18:13:00 5.2 5.0 36.4 36.1 - - 80 0 958
6/3/2021 18:14:00 5.1 5.0 36.4 36.0 - - 80 0 957
6/3/2021 18:15:00 5.2 5.0 36.4 36.0 - - 80 0 957
6/3/2021 18:16:00 4.9 5.0 36.3 36.0 - - 80 0 963
6/3/2021 18:17:00 5.2 5.0 36.3 35.9 - - 80 0 963
6/3/2021 18:18:00 4.8 5.0 36.3 35.9 - - 80 0 963
6/3/2021 18:19:00 5.2 5.0 36.2 35.9 - - 80 0 969
6/3/2021 18:20:00 4.8 5.0 36.2 35.8 - - 80 0 968
6/3/2021 18:21:00 5.2 5.0 36.2 35.8 - - 80 0 974
6/3/2021 18:22:00 4.8 5.0 36.1 35.8 - - 80 0 973
6/3/2021 18:23:00 5.2 5.0 36.0 35.7 - - 80 0 974

-------------------------------------------
Approved by Date Page: 7 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 18:24:00 4.9 5.0 36.0 35.7 - - 80 0 980
6/3/2021 18:25:00 5.2 5.0 36.0 35.6 - - 80 0 980
6/3/2021 18:26:00 4.9 5.0 36.0 35.6 - - 80 0 980
6/3/2021 18:27:00 5.2 5.0 35.9 35.6 - - 80 0 985
6/3/2021 18:28:00 4.8 5.0 35.9 35.5 - - 80 0 985
6/3/2021 18:29:00 5.2 5.0 35.8 35.5 - - 80 0 991
6/3/2021 18:30:00 4.9 5.0 35.8 35.5 - - 80 0 992
6/3/2021 18:31:00 5.2 5.0 35.8 35.4 - - 80 0 991
6/3/2021 18:32:00 4.9 5.0 35.8 35.4 - - 80 0 997
6/3/2021 18:33:00 5.2 5.0 35.7 35.3 - - 80 0 997
6/3/2021 18:34:00 5.1 5.0 35.7 35.3 - - 80 0 996
6/3/2021 18:35:00 5.2 5.0 35.7 35.2 - - 80 0 -
6/3/2021 18:36:00 4.7 5.0 35.6 35.2 - - 80 0 -
6/3/2021 18:37:00 5.2 5.0 35.6 35.2 - - 80 0 -
6/3/2021 18:38:00 4.9 5.0 35.5 35.1 - - 80 0 -
6/3/2021 18:39:00 5.2 5.0 35.5 35.1 - - 80 0 -
6/3/2021 18:40:00 4.7 5.0 35.4 35.1 - - 80 0 -
6/3/2021 18:41:00 5.2 5.0 35.4 35.0 - - 80 0 -
6/3/2021 18:42:00 4.9 5.0 35.4 35.0 - - 80 0 -
6/3/2021 18:43:00 5.2 5.0 35.3 35.0 - - 80 0 -
6/3/2021 18:44:00 4.8 5.0 35.3 34.9 - - 80 0 -
6/3/2021 18:45:00 5.1 5.0 35.3 34.9 - - 80 0 -
6/3/2021 18:46:00 4.9 5.0 35.2 34.8 - - 80 0 -
6/3/2021 18:47:00 5.2 5.0 35.2 34.8 - - 80 0 -
6/3/2021 18:48:00 4.7 5.0 35.2 34.8 - - 80 0 -
6/3/2021 18:49:00 5.2 5.0 35.1 34.7 - - 80 0 -
6/3/2021 18:50:00 4.9 5.0 35.1 34.7 - - 80 0 -

-------------------------------------------
Approved by Date Page: 8 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 18:51:00 5.2 5.0 35.1 34.7 - - 80 0 -
6/3/2021 18:52:00 4.9 5.0 35.0 34.6 - - 80 0 -
6/3/2021 18:53:00 5.2 5.0 35.0 34.6 - - 80 0 -
6/3/2021 18:54:00 4.9 5.0 35.0 34.6 - - 80 0 -
6/3/2021 18:55:00 5.2 5.0 35.0 34.5 - - 80 0 -
6/3/2021 18:56:00 4.9 5.0 34.9 34.5 - - 80 0 -
6/3/2021 18:57:00 5.2 5.0 34.8 34.5 - - 80 0 -
6/3/2021 18:58:00 4.7 5.0 34.8 34.4 - - 80 0 -
6/3/2021 18:59:00 5.1 5.0 34.8 34.4 - - 80 0 -
6/3/2021 19:00:00 4.7 5.0 34.7 34.4 - - 80 0 -
6/3/2021 19:01:00 5.2 5.0 34.7 34.3 - - 80 0 -
6/3/2021 19:02:00 4.9 5.0 34.7 34.3 - - 80 0 -
6/3/2021 19:03:00 5.1 5.0 34.7 34.3 - - 80 0 -
6/3/2021 19:04:00 4.9 5.0 34.6 34.2 - - 80 0 -
6/3/2021 19:05:00 5.2 5.0 34.6 34.2 - - 80 0 -
6/3/2021 19:06:00 4.7 5.0 34.5 34.1 - - 80 0 -
6/3/2021 19:07:00 5.2 5.0 34.5 34.2 - - 80 0 -
6/3/2021 19:08:00 4.9 5.0 34.4 34.1 - - 80 0 -
6/3/2021 19:09:00 5.2 5.0 34.4 34.0 - - 80 0 -
6/3/2021 19:10:00 4.7 5.0 34.4 34.0 - - 80 0 -
6/3/2021 19:11:00 5.2 5.0 34.4 34.0 - - 80 0 -
6/3/2021 19:12:00 4.9 5.0 34.3 33.9 - - 80 0 -
6/3/2021 19:13:00 5.2 5.0 34.3 33.9 - - 80 0 -
6/3/2021 19:14:00 5.0 5.0 34.2 33.9 - - 80 0 -
6/3/2021 19:15:00 5.1 5.0 34.2 33.8 - - 80 0 -
6/3/2021 19:16:00 4.7 5.0 34.2 33.8 - - 80 0 -
6/3/2021 19:17:00 5.1 5.0 34.1 33.8 - - 80 0 -

-------------------------------------------
Approved by Date Page: 9 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 19:18:00 4.9 5.0 34.1 33.8 - - 80 0 -
6/3/2021 19:19:00 5.2 5.0 34.1 33.7 - - 80 0 -
6/3/2021 19:20:00 4.9 5.0 34.0 33.7 - - 80 0 -
6/3/2021 19:21:00 5.2 5.0 34.0 33.6 - - 80 0 -
6/3/2021 19:22:00 4.9 5.0 34.0 33.6 - - 80 0 -
6/3/2021 19:23:00 5.1 5.0 33.9 33.6 - - 80 0 -
6/3/2021 19:24:00 4.7 5.0 33.9 33.5 - - 80 0 -
6/3/2021 19:25:00 5.2 5.0 33.9 33.5 - - 80 0 -
6/3/2021 19:26:00 5.0 5.0 33.9 33.4 - - 80 0 -
6/3/2021 19:27:00 5.2 5.0 33.8 33.4 - - 80 0 -
6/3/2021 19:28:00 4.9 5.0 33.8 33.4 - - 80 0 -
6/3/2021 19:29:00 5.1 5.0 33.7 33.4 - - 80 0 -
6/3/2021 19:30:00 4.9 5.0 33.7 33.3 - - 80 0 -
6/3/2021 19:31:00 5.2 5.0 33.7 33.3 - - 80 0 -
6/3/2021 19:32:00 4.9 5.0 33.6 33.3 - - 80 0 -
6/3/2021 19:33:00 5.2 5.0 33.6 33.2 - - 80 0 -
6/3/2021 19:34:00 4.9 5.0 33.6 33.2 - - 80 0 -
6/3/2021 19:35:00 5.1 5.0 33.5 33.2 - - 80 0 -
6/3/2021 19:36:00 5.2 5.0 33.5 33.1 - - 80 0 -
6/3/2021 19:37:00 4.9 5.0 33.5 33.1 - - 80 0 -
6/3/2021 19:38:00 5.2 5.0 33.4 33.1 - - 80 0 -
6/3/2021 19:39:00 4.7 5.0 33.4 33.0 - - 80 0 -
6/3/2021 19:40:00 5.2 5.0 33.3 33.0 - - 80 0 -
6/3/2021 19:41:00 4.9 5.0 33.3 32.9 - - 80 0 -
6/3/2021 19:42:00 5.2 5.0 33.3 32.9 - - 80 0 -
6/3/2021 19:43:00 4.7 5.0 33.3 32.9 - - 80 0 -
6/3/2021 19:44:00 5.2 5.0 33.2 32.8 - - 80 0 -

-------------------------------------------
Approved by Date Page: 10 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 19:45:00 4.9 5.0 33.2 32.8 - - 80 0 -
6/3/2021 19:46:00 5.2 5.0 33.1 32.8 - - 80 0 -
6/3/2021 19:47:00 4.7 5.0 33.1 32.8 - - 80 0 -
6/3/2021 19:48:00 5.2 5.0 33.1 32.7 - - 80 0 -
6/3/2021 19:49:00 4.8 5.0 33.0 32.7 - - 80 0 -
6/3/2021 19:50:00 5.2 5.0 33.0 32.6 - - 80 0 -
6/3/2021 19:51:00 4.8 5.0 33.0 32.6 - - 80 0 -
6/3/2021 19:52:00 5.2 5.0 33.0 32.6 - - 80 0 -
6/3/2021 19:53:00 5.0 5.0 32.9 32.6 - - 80 0 -
6/3/2021 19:54:00 5.2 5.0 32.9 32.5 - - 80 0 -
6/3/2021 19:55:00 4.8 5.0 32.8 32.5 - - 80 0 -
6/3/2021 19:56:00 5.2 5.0 32.8 32.4 - - 80 0 -
6/3/2021 19:57:00 4.8 5.0 32.8 32.4 - - 80 0 -
6/3/2021 19:58:00 5.2 5.0 32.8 32.4 - - 80 0 -
6/3/2021 19:59:00 4.8 5.0 32.7 32.4 - - 80 0 -
6/3/2021 20:00:00 5.2 5.0 32.6 32.3 - - 80 0 -
6/3/2021 20:01:00 4.8 5.0 32.6 32.3 - - 80 0 -
6/3/2021 20:02:00 5.2 5.0 32.6 32.2 - - 80 0 -
6/3/2021 20:03:00 4.8 5.0 32.6 32.2 - - 80 0 -
6/3/2021 20:04:00 5.2 5.0 32.5 32.2 - - 80 0 -
6/3/2021 20:05:00 4.8 5.0 32.5 32.2 - - 80 0 -
6/3/2021 20:06:00 5.2 5.0 32.5 32.1 - - 80 0 -
6/3/2021 20:07:00 4.8 5.0 32.4 32.1 - - 80 0 -
6/3/2021 20:08:00 5.2 5.0 32.4 32.0 - - 80 0 -
6/3/2021 20:09:00 4.8 5.0 32.4 32.0 - - 80 0 -
6/3/2021 20:10:00 5.2 5.0 32.4 32.0 - - 80 0 -
6/3/2021 20:11:00 5.0 5.0 32.3 32.0 - - 80 0 -

-------------------------------------------
Approved by Date Page: 11 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 20:12:00 5.2 5.0 32.3 31.9 - - 80 0 -
6/3/2021 20:13:00 4.8 5.0 32.2 31.9 - - 80 0 -
6/3/2021 20:14:00 5.2 5.0 32.2 31.9 - - 80 0 -
6/3/2021 20:15:00 4.9 5.0 32.2 31.8 - - 80 0 -
6/3/2021 20:16:00 5.2 5.0 32.1 31.8 - - 80 0 -
6/3/2021 20:17:00 4.8 5.0 32.1 31.8 - - 80 0 -
6/3/2021 20:18:00 5.2 5.0 32.1 31.7 - - 80 0 -
6/3/2021 20:19:00 5.0 5.0 32.0 31.7 - - 80 0 -
6/3/2021 20:20:00 5.2 5.0 32.0 31.6 - - 80 0 -
6/3/2021 20:21:00 4.8 5.0 32.0 31.6 - - 80 0 -
6/3/2021 20:22:00 5.2 5.0 32.0 31.6 - - 80 0 -
6/3/2021 20:23:00 4.8 5.0 31.9 31.6 - - 80 0 -
6/3/2021 20:24:00 5.2 5.0 31.9 31.6 - - 80 0 -
6/3/2021 20:25:00 4.8 5.0 31.8 31.5 - - 80 0 -
6/3/2021 20:26:00 5.2 5.0 31.8 31.4 - - 80 0 -
6/3/2021 20:27:00 4.8 5.0 31.8 31.4 - - 80 0 -
6/3/2021 20:28:00 5.2 5.0 31.8 31.4 - - 80 0 -
6/3/2021 20:29:00 5.0 5.0 31.7 31.4 - - 80 0 -
6/3/2021 20:30:00 5.2 5.0 31.7 31.4 - - 80 0 -
6/3/2021 20:31:00 5.3 5.0 31.7 31.3 - - 80 0 -
6/3/2021 20:32:00 4.8 5.0 31.6 31.3 - - 80 0 -
6/3/2021 20:33:00 5.3 5.0 31.6 31.3 - - 80 0 -
6/3/2021 20:34:00 5.0 5.0 31.6 31.2 - - 80 0 -
6/3/2021 20:35:00 5.2 5.0 31.6 31.2 - - 80 0 -
6/3/2021 20:36:00 4.8 5.0 31.5 31.2 - - 80 0 -
6/3/2021 20:37:00 5.2 5.0 31.5 31.1 - - 80 0 -
6/3/2021 20:38:00 4.8 5.0 31.4 31.1 - - 80 0 -

-------------------------------------------
Approved by Date Page: 12 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 20:39:00 5.2 5.0 31.4 31.1 - - 80 0 -
6/3/2021 20:40:00 4.8 5.0 31.4 31.0 - - 80 0 -
6/3/2021 20:41:00 5.2 5.0 31.4 31.0 - - 80 0 -
6/3/2021 20:42:00 4.8 5.0 31.3 30.9 - - 80 0 -
6/3/2021 20:43:00 5.2 5.0 31.3 31.0 - - 80 0 -
6/3/2021 20:44:00 4.8 5.0 31.2 30.9 - - 80 0 -
6/3/2021 20:45:00 5.2 5.0 31.2 30.9 - - 80 0 -
6/3/2021 20:46:00 4.9 5.0 31.2 30.8 - - 80 0 -
6/3/2021 20:47:00 5.2 5.0 31.2 30.8 - - 80 0 -
6/3/2021 20:48:00 4.8 5.0 31.2 30.8 - - 80 0 -
6/3/2021 20:49:00 5.2 5.0 31.1 30.8 - - 80 0 -
6/3/2021 20:50:00 4.8 5.0 31.1 30.7 - - 80 0 -
6/3/2021 20:51:00 5.2 5.0 31.0 30.7 - - 80 0 -
6/3/2021 20:52:00 4.8 5.0 31.0 30.7 - - 80 0 -
6/3/2021 20:53:00 5.2 5.0 31.0 30.6 - - 80 0 -
6/3/2021 20:54:00 4.8 5.0 31.0 30.6 - - 80 0 -
6/3/2021 20:55:00 5.2 5.0 30.9 30.6 - - 80 0 -
6/3/2021 20:56:00 4.8 5.0 30.9 30.5 - - 80 0 -
6/3/2021 20:57:00 5.2 5.0 30.8 30.5 - - 80 0 -
6/3/2021 20:58:00 4.5 5.0 30.8 30.4 - - 80 0 -
6/3/2021 20:59:00 5.3 5.0 30.8 30.4 - - 80 0 -
6/3/2021 21:00:00 4.6 5.0 30.7 30.4 - - 80 0 -
6/3/2021 21:01:00 5.3 5.0 30.7 30.4 - - 80 0 -
6/3/2021 21:02:00 4.8 5.0 30.7 30.3 - - 80 0 -
6/3/2021 21:03:00 5.2 5.0 30.6 30.3 - - 80 0 -
6/3/2021 21:04:00 4.8 5.0 30.6 30.3 - - 80 0 -
6/3/2021 21:05:00 5.2 5.0 30.6 30.3 - - 80 0 -

-------------------------------------------
Approved by Date Page: 13 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 21:06:00 4.8 5.0 30.6 30.2 - - 80 0 -
6/3/2021 21:07:00 5.2 5.0 30.5 30.2 - - 80 0 -
6/3/2021 21:08:00 5.0 5.0 30.5 30.2 - - 80 0 -
6/3/2021 21:09:00 5.2 5.0 30.5 30.1 - - 80 0 -
6/3/2021 21:10:00 4.8 5.0 30.4 30.1 - - 80 0 -
6/3/2021 21:11:00 5.2 5.0 30.4 30.1 - - 80 0 -
6/3/2021 21:12:00 4.8 5.0 30.4 30.1 - - 80 0 -
6/3/2021 21:13:00 5.2 5.0 30.3 30.0 - - 80 0 -
6/3/2021 21:14:00 4.8 5.0 30.3 30.0 - - 80 0 -
6/3/2021 21:15:00 5.2 5.0 30.3 30.0 - - 80 0 -
6/3/2021 21:16:00 4.9 5.0 30.3 29.9 - - 80 0 -
6/3/2021 21:17:00 5.2 5.0 30.2 29.9 - - 80 0 -
6/3/2021 21:18:00 4.9 5.0 30.2 29.9 - - 80 0 -
6/3/2021 21:19:00 5.2 5.0 30.1 29.8 - - 80 0 -
6/3/2021 21:20:00 4.9 5.0 30.2 29.8 - - 80 0 -
6/3/2021 21:21:00 5.2 5.0 30.1 29.8 - - 80 0 -
6/3/2021 21:22:00 4.9 5.0 30.1 29.7 - - 80 0 -
6/3/2021 21:23:00 5.2 5.0 30.0 29.7 - - 80 0 -
6/3/2021 21:24:00 4.9 5.0 30.0 29.7 - - 80 0 -
6/3/2021 21:25:00 5.2 5.0 30.0 29.7 - - 80 0 -
6/3/2021 21:26:00 4.9 5.0 29.9 29.7 - - 80 0 -
6/3/2021 21:27:00 5.2 5.0 30.0 29.6 - - 80 0 -
6/3/2021 21:28:00 4.8 5.0 29.9 29.5 - - 80 0 -
6/3/2021 21:29:00 5.2 5.0 29.9 29.5 - - 80 0 -
6/3/2021 21:30:00 4.8 5.0 29.9 29.5 - - 80 0 -
6/3/2021 21:31:00 5.2 5.0 29.8 29.5 - - 80 0 -
6/3/2021 21:32:00 4.9 5.0 29.8 29.5 - - 80 0 -

-------------------------------------------
Approved by Date Page: 14 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 21:33:00 5.2 5.0 29.7 29.4 - - 80 0 -
6/3/2021 21:34:00 4.9 5.0 29.8 29.4 - - 80 0 -
6/3/2021 21:35:00 5.2 5.0 29.7 29.4 - - 80 0 -
6/3/2021 21:36:00 4.8 5.0 29.6 29.3 - - 80 0 -
6/3/2021 21:37:00 5.2 5.0 29.6 29.3 - - 80 0 -
6/3/2021 21:38:00 4.8 5.0 29.6 29.3 - - 80 0 -
6/3/2021 21:39:00 5.2 5.0 29.5 29.2 - - 80 0 -
6/3/2021 21:40:00 4.9 5.0 29.5 29.2 - - 80 0 -
6/3/2021 21:41:00 5.2 5.0 29.5 29.2 - - 80 0 -
6/3/2021 21:42:00 4.8 5.0 29.5 29.2 - - 80 0 -
6/3/2021 21:43:00 5.2 5.0 29.5 29.1 - - 80 0 -
6/3/2021 21:44:00 4.8 5.0 29.4 29.1 - - 80 0 -
6/3/2021 21:45:00 5.2 5.0 29.4 29.1 - - 80 0 -
6/3/2021 21:46:00 4.8 5.0 29.4 29.0 - - 80 0 -
6/3/2021 21:47:00 5.2 5.0 29.3 29.1 - - 80 0 -
6/3/2021 21:48:00 4.8 5.0 29.3 29.0 - - 80 0 -
6/3/2021 21:49:00 5.2 5.0 29.3 29.0 - - 80 0 -
6/3/2021 21:50:00 4.9 5.0 29.2 29.0 - - 80 0 -
6/3/2021 21:51:00 5.2 5.0 29.2 28.9 - - 80 0 -
6/3/2021 21:52:00 4.9 5.0 29.2 28.9 - - 80 0 -
6/3/2021 21:53:00 5.2 5.0 29.2 28.9 - - 80 0 -
6/3/2021 21:54:00 4.8 5.0 29.1 28.8 - - 80 0 -
6/3/2021 21:55:00 5.2 5.0 29.1 28.8 - - 80 0 -
6/3/2021 21:56:00 4.9 5.0 29.1 28.8 - - 80 0 -
6/3/2021 21:57:00 5.2 5.0 29.1 28.7 - - 80 0 -
6/3/2021 21:58:00 4.8 5.0 29.0 28.7 - - 80 0 -
6/3/2021 21:59:00 5.2 5.0 29.0 28.7 - - 80 0 -

-------------------------------------------
Approved by Date Page: 15 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 22:00:00 4.8 5.0 29.0 28.7 - - 80 0 -
6/3/2021 22:01:00 5.2 5.0 28.9 28.6 - - 80 0 -
6/3/2021 22:02:00 4.8 5.0 28.9 28.6 - - 80 0 -
6/3/2021 22:03:00 5.2 5.0 28.9 28.6 - - 80 0 -
6/3/2021 22:04:00 4.8 5.0 28.8 28.5 - - 80 0 -
6/3/2021 22:05:00 5.2 5.0 28.8 28.5 - - 80 0 -
6/3/2021 22:06:00 4.8 5.0 28.8 28.5 - - 80 0 -
6/3/2021 22:07:00 5.2 5.0 28.8 28.5 - - 80 0 -
6/3/2021 22:08:00 4.8 5.0 28.7 28.5 - - 80 0 -
6/3/2021 22:09:00 5.2 5.0 28.7 28.4 - - 80 0 -
6/3/2021 22:10:00 4.8 5.0 28.7 28.4 - - 80 0 -
6/3/2021 22:11:00 5.2 5.0 28.6 28.3 - - 80 0 -
6/3/2021 22:12:00 4.9 5.0 28.6 28.3 - - 80 0 -
6/3/2021 22:13:00 5.2 5.0 28.6 28.3 - - 80 0 -
6/3/2021 22:14:00 4.8 5.0 28.6 28.3 - - 80 0 -
6/3/2021 22:15:00 5.2 5.0 28.5 28.3 - - 80 0 -
6/3/2021 22:16:00 4.8 5.0 28.5 28.2 - - 80 0 -
6/3/2021 22:17:00 5.3 5.0 28.5 28.2 - - 80 0 -
6/3/2021 22:18:00 4.8 5.0 28.4 28.2 - - 80 0 -
6/3/2021 22:19:00 5.2 5.0 28.4 28.1 - - 80 0 -
6/3/2021 22:20:00 4.8 5.0 28.4 28.1 - - 80 0 -
6/3/2021 22:21:00 5.2 5.0 28.3 28.1 - - 80 0 -
6/3/2021 22:22:00 4.8 5.0 28.3 28.1 - - 80 0 -
6/3/2021 22:23:00 5.2 5.0 28.3 28.0 - - 80 0 -
6/3/2021 22:24:00 5.0 5.0 28.3 28.0 - - 80 0 -
6/3/2021 22:25:00 5.3 5.0 28.3 27.9 - - 80 0 -
6/3/2021 22:26:00 4.9 5.0 28.2 27.9 - - 80 0 -

-------------------------------------------
Approved by Date Page: 16 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 22:27:00 5.2 5.0 28.2 27.9 - - 80 0 -
6/3/2021 22:28:00 4.9 5.0 28.2 27.9 - - 80 0 -
6/3/2021 22:29:00 5.2 5.0 28.1 27.8 - - 80 0 -
6/3/2021 22:30:00 4.5 5.0 28.1 27.8 - - 80 0 -
6/3/2021 22:31:00 5.2 5.0 28.1 27.8 - - 80 0 -
6/3/2021 22:32:00 4.9 5.0 28.1 27.8 - - 80 0 -
6/3/2021 22:33:00 5.2 5.0 28.1 27.8 - - 80 0 -
6/3/2021 22:34:00 5.0 5.0 28.0 27.7 - - 80 0 -
6/3/2021 22:35:00 5.2 5.0 27.9 27.7 - - 80 0 -
6/3/2021 22:36:00 4.8 5.0 27.9 27.7 - - 80 0 -
6/3/2021 22:37:00 5.2 5.0 27.9 27.7 - - 80 0 -
6/3/2021 22:38:00 4.8 5.0 27.9 27.6 - - 80 0 -
6/3/2021 22:39:00 5.2 5.0 27.9 27.6 - - 80 0 -
6/3/2021 22:40:00 4.8 5.0 27.9 27.6 - - 80 0 -
6/3/2021 22:41:00 5.2 5.0 27.8 27.5 - - 80 0 -
6/3/2021 22:42:00 4.8 5.0 27.8 27.5 - - 80 0 -
6/3/2021 22:43:00 5.2 5.0 27.7 27.5 - - 80 0 -
6/3/2021 22:44:00 4.7 5.0 27.7 27.5 - - 80 0 -
6/3/2021 22:45:00 5.2 5.0 27.7 27.4 - - 80 0 -
6/3/2021 22:46:00 4.9 5.0 27.7 27.4 - - 80 0 -
6/3/2021 22:47:00 5.2 5.0 27.6 27.4 - - 80 0 -
6/3/2021 22:48:00 4.9 5.0 27.6 27.4 - - 80 0 -
6/3/2021 22:49:00 5.2 5.0 27.6 27.4 - - 80 0 -
6/3/2021 22:50:00 4.9 5.0 27.6 27.3 - - 80 0 -
6/3/2021 22:51:00 5.2 5.0 27.5 27.3 - - 80 0 -
6/3/2021 22:52:00 4.8 5.0 27.5 27.2 - - 80 0 -
6/3/2021 22:52:01 Alarm: CLOSE - Communication fail with SQL database.

-------------------------------------------
Approved by Date Page: 17 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 22:53:00 5.2 5.0 27.5 27.2 - - 80 0 -
6/3/2021 22:54:00 4.9 5.0 27.5 27.2 - - 80 0 -
6/3/2021 22:55:00 5.2 5.0 27.4 27.1 - - 80 0 -
6/3/2021 22:56:00 4.8 5.0 27.4 27.1 - - 80 0 -
6/3/2021 22:57:00 5.2 5.0 27.4 27.1 - - 80 0 -
6/3/2021 22:58:00 4.9 5.0 27.4 27.1 - - 80 0 -
6/3/2021 22:59:00 5.2 5.0 27.3 27.0 - - 80 0 -
6/3/2021 23:00:00 4.9 5.0 27.3 27.1 - - 80 0 -
6/3/2021 23:01:00 5.2 5.0 27.3 27.0 - - 80 0 -
6/3/2021 23:02:00 4.9 5.0 27.3 26.9 - - 80 0 -
6/3/2021 23:03:00 5.2 5.0 27.2 26.9 - - 80 0 -
6/3/2021 23:04:00 4.9 5.0 27.2 26.9 - - 80 0 -
6/3/2021 23:05:00 5.2 5.0 27.2 26.9 - - 80 0 -
6/3/2021 23:06:00 4.9 5.0 27.1 26.8 - - 80 0 -
6/3/2021 23:07:00 5.2 5.0 27.1 26.8 - - 80 0 -
6/3/2021 23:08:00 4.9 5.0 27.1 26.8 - - 80 0 -
6/3/2021 23:09:00 5.2 5.0 27.0 26.8 - - 80 0 -
6/3/2021 23:10:00 4.9 5.0 27.0 26.8 - - 80 0 -
6/3/2021 23:11:00 5.2 5.0 27.0 26.7 - - 80 0 -
6/3/2021 23:12:00 4.9 5.0 26.9 26.7 - - 80 0 -
6/3/2021 23:13:00 5.2 5.0 26.9 26.7 - - 80 0 -
6/3/2021 23:14:00 4.9 5.0 26.9 26.7 - - 80 0 -
6/3/2021 23:15:00 5.2 5.0 26.9 26.7 - - 80 0 -
6/3/2021 23:16:00 4.7 5.0 26.9 26.6 - - 80 0 -
6/3/2021 23:17:00 5.2 5.0 26.9 26.6 - - 80 0 -
6/3/2021 23:18:00 4.9 5.0 26.8 26.5 - - 80 0 -
6/3/2021 23:19:00 5.1 5.0 26.8 26.5 - - 80 0 -

-------------------------------------------
Approved by Date Page: 18 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 23:20:00 4.7 5.0 26.8 26.5 - - 80 0 -
6/3/2021 23:21:00 5.2 5.0 26.8 26.5 - - 80 0 -
6/3/2021 23:22:00 4.9 5.0 26.7 26.4 - - 80 0 -
6/3/2021 23:23:00 5.2 5.0 26.7 26.4 - - 80 0 -
6/3/2021 23:24:00 4.9 5.0 26.6 26.4 - - 80 0 -
6/3/2021 23:25:00 5.2 5.0 26.6 26.4 - - 80 0 -
6/3/2021 23:26:00 4.9 5.0 26.6 26.3 - - 80 0 -
6/3/2021 23:27:00 5.2 5.0 26.6 26.3 - - 80 0 -
6/3/2021 23:28:00 4.9 5.0 26.6 26.3 - - 80 0 -
6/3/2021 23:29:00 5.2 5.0 26.5 26.3 - - 80 0 -
6/3/2021 23:30:00 5.0 5.0 26.5 26.3 - - 80 0 -
6/3/2021 23:31:00 5.2 5.0 26.5 26.3 - - 80 0 -
6/3/2021 23:32:00 4.9 5.0 26.5 26.2 - - 80 0 -
6/3/2021 23:33:00 5.1 5.0 26.4 26.2 - - 80 0 -
6/3/2021 23:34:00 4.7 5.0 26.4 26.1 - - 80 0 -
6/3/2021 23:35:00 5.2 5.0 26.4 26.1 - - 80 0 -
6/3/2021 23:36:00 5.0 5.0 26.4 26.1 - - 80 0 -
6/3/2021 23:37:00 5.2 5.0 26.3 26.1 - - 80 0 -
6/3/2021 23:38:00 4.8 5.0 26.3 26.0 - - 80 0 -
6/3/2021 23:39:00 5.2 5.0 26.3 26.0 - - 80 0 -
6/3/2021 23:40:00 4.9 5.0 26.3 26.0 - - 80 0 -
6/3/2021 23:41:00 5.2 5.0 26.3 26.0 - - 80 0 -
6/3/2021 23:42:00 4.9 5.0 26.2 25.9 - - 80 0 -
6/3/2021 23:43:00 5.2 5.0 26.2 25.9 - - 80 0 -
6/3/2021 23:44:00 4.7 5.0 26.1 25.9 - - 80 0 -
6/3/2021 23:45:00 5.2 5.0 26.1 25.9 - - 80 0 -
6/3/2021 23:46:00 4.9 5.0 26.1 25.8 - - 80 0 -

-------------------------------------------
Approved by Date Page: 19 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/3/2021 23:47:00 5.2 5.0 26.1 25.8 - - 80 0 -
6/3/2021 23:48:00 4.7 5.0 26.0 25.7 - - 80 0 -
6/3/2021 23:49:00 5.2 5.0 26.0 25.8 - - 80 0 -
6/3/2021 23:50:00 4.9 5.0 26.0 25.7 - - 80 0 -
6/3/2021 23:51:00 5.2 5.0 26.0 25.7 - - 80 0 -
6/3/2021 23:52:00 4.9 5.0 25.9 25.7 - - 80 0 -
6/3/2021 23:53:00 5.2 5.0 25.9 25.7 - - 80 0 -
6/3/2021 23:54:00 4.9 5.0 25.9 25.7 - - 80 0 -
6/3/2021 23:55:00 5.2 5.0 25.9 25.6 - - 80 0 -
6/3/2021 23:56:00 4.9 5.0 25.8 25.6 - - 80 0 -
6/3/2021 23:57:00 5.2 5.0 25.8 25.6 - - 80 0 -
6/3/2021 23:58:00 4.9 5.0 25.8 25.5 - - 80 0 -
6/3/2021 23:59:00 5.2 5.0 25.7 25.5 - - 80 0 -
6/4/2021 00:00:00 4.8 5.0 25.7 25.5 - - 80 0 -
6/4/2021 00:01:00 5.2 5.0 25.7 25.5 - - 80 0 -
6/4/2021 00:01:02 Audit: - Security Synchronizer: Beginning security synchronization process by SecuritySyochronizer.
Audit: - Security Synchronizer: Function is not enabled on this node, check license/key by SecuritySyochronizer.
6/4/2021 00:02:00 4.8 5.0 25.7 25.4 - - 80 0 -
6/4/2021 00:03:00 5.2 5.0 25.7 25.4 - - 80 0 -
6/4/2021 00:04:00 4.9 5.0 25.6 25.4 - - 80 0 -
6/4/2021 00:05:00 5.2 5.0 25.6 25.4 - - 80 0 -
6/4/2021 00:06:00 4.8 5.0 25.6 25.3 - - 80 0 -
6/4/2021 00:07:00 5.2 5.0 25.6 25.3 - - 80 0 -
6/4/2021 00:08:00 4.8 5.0 25.5 25.3 - - 80 0 -
6/4/2021 00:09:00 5.2 5.0 25.5 25.3 - - 80 0 -
6/4/2021 00:10:00 5.1 5.0 25.5 25.3 - - 80 0 -
6/4/2021 00:11:00 5.2 5.0 25.5 25.2 - - 80 0 -

-------------------------------------------
Approved by Date Page: 20 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 00:12:00 4.8 5.0 25.4 25.2 - - 80 0 -
6/4/2021 00:13:00 5.2 5.0 25.4 25.2 - - 80 0 -
6/4/2021 00:14:00 4.8 5.0 25.4 25.2 - - 80 0 -
6/4/2021 00:15:00 5.3 5.0 25.4 25.1 - - 80 0 -
6/4/2021 00:16:00 4.8 5.0 25.3 25.1 - - 80 0 -
6/4/2021 00:17:00 5.2 5.0 25.3 25.0 - - 80 0 -
6/4/2021 00:18:00 4.8 5.0 25.3 25.1 - - 80 0 -
6/4/2021 00:19:00 5.2 5.0 25.2 25.0 - - 80 0 -
6/4/2021 00:20:00 4.8 5.0 25.2 25.0 - - 80 0 -
6/4/2021 00:21:00 5.2 5.0 25.2 25.0 - - 80 0 -
6/4/2021 00:22:00 5.0 5.0 25.2 24.9 - - 80 0 -
6/4/2021 00:23:00 5.2 5.0 25.1 24.9 - - 80 0 -
6/4/2021 00:24:00 4.8 5.0 25.2 24.9 - - 80 0 -
6/4/2021 00:25:00 5.2 5.0 25.1 24.9 - - 80 0 -
6/4/2021 00:26:00 4.8 5.0 25.1 24.9 - - 80 0 -
6/4/2021 00:27:00 5.2 5.0 25.1 24.9 - - 80 0 -
6/4/2021 00:28:00 4.8 5.0 25.1 24.8 - - 80 0 -
6/4/2021 00:29:00 5.2 5.0 25.0 24.8 - - 80 0 -
6/4/2021 00:30:00 4.8 5.0 24.9 24.8 - - 80 0 -
6/4/2021 00:31:00 5.2 5.0 25.0 24.7 - - 80 0 -
6/4/2021 00:32:00 4.8 5.0 24.9 24.7 - - 80 0 -
6/4/2021 00:33:00 5.2 5.0 24.9 24.7 - - 80 0 -
6/4/2021 00:34:00 4.8 5.0 24.9 24.7 - - 80 0 -
6/4/2021 00:35:00 5.2 5.0 24.9 24.7 - - 80 0 -
6/4/2021 00:36:00 4.9 5.0 24.8 24.7 - - 80 0 -
6/4/2021 00:37:00 5.2 5.0 24.8 24.6 - - 80 0 -
6/4/2021 00:38:00 4.8 5.0 24.8 24.6 - - 80 0 -

-------------------------------------------
Approved by Date Page: 21 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 00:39:00 5.2 5.0 24.7 24.5 - - 80 0 -
6/4/2021 00:40:00 4.8 5.0 24.7 24.5 - - 80 0 -
6/4/2021 00:41:00 5.2 5.0 24.7 24.5 - - 80 0 -
6/4/2021 00:42:00 4.8 5.0 24.7 24.5 - - 80 0 -
6/4/2021 00:43:00 5.2 5.0 24.7 24.5 - - 80 0 -
6/4/2021 00:44:00 4.9 5.0 24.6 24.4 - - 80 0 -
6/4/2021 00:45:00 5.2 5.0 24.6 24.4 - - 80 0 -
6/4/2021 00:46:00 5.0 5.0 24.6 24.4 - - 80 0 -
6/4/2021 00:47:00 5.3 5.0 24.5 24.3 - - 80 0 -
6/4/2021 00:48:00 4.5 5.0 24.5 24.4 - - 80 0 -
6/4/2021 00:49:00 5.1 5.0 24.5 24.3 - - 80 0 -
6/4/2021 00:50:00 4.8 5.0 24.5 24.3 - - 80 0 -
6/4/2021 00:51:00 5.2 5.0 24.5 24.3 - - 80 0 -
6/4/2021 00:52:00 4.8 5.0 24.4 24.3 - - 80 0 -
6/4/2021 00:53:00 5.3 5.0 24.4 24.3 - - 80 0 -
6/4/2021 00:54:00 4.7 5.0 24.4 24.2 - - 80 0 -
6/4/2021 00:55:00 5.2 5.0 24.4 24.2 - - 80 0 -
6/4/2021 00:56:00 4.8 5.0 24.3 24.1 - - 80 0 -
6/4/2021 00:57:00 5.2 5.0 24.3 24.1 - - 80 0 -
6/4/2021 00:58:00 5.0 5.0 24.3 24.1 - - 80 0 -
6/4/2021 00:59:00 5.2 5.0 24.3 24.1 - - 80 0 -
6/4/2021 01:00:00 4.8 5.0 24.3 24.1 - - 80 0 -
6/4/2021 01:01:00 5.2 5.0 24.3 24.1 - - 80 0 -
6/4/2021 01:02:00 4.9 5.0 24.2 24.0 - - 80 0 -
6/4/2021 01:03:00 5.2 5.0 24.2 24.0 - - 80 0 -
6/4/2021 01:04:00 4.8 5.0 24.1 24.0 - - 80 0 -
6/4/2021 01:05:00 5.2 5.0 24.1 23.9 - - 80 0 -

-------------------------------------------
Approved by Date Page: 22 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 01:06:00 4.8 5.0 24.1 23.9 - - 80 0 -
6/4/2021 01:07:00 5.2 5.0 24.1 23.9 - - 80 0 -
6/4/2021 01:08:00 4.8 5.0 24.1 23.9 - - 80 0 -
6/4/2021 01:09:00 5.2 5.0 24.0 23.8 - - 80 0 -
6/4/2021 01:10:00 4.8 5.0 24.0 23.9 - - 80 0 -
6/4/2021 01:11:00 5.2 5.0 23.9 23.8 - - 80 0 -
6/4/2021 01:12:00 4.9 5.0 24.0 23.8 - - 80 0 -
6/4/2021 01:13:00 5.2 5.0 23.9 23.8 - - 80 0 -
6/4/2021 01:14:00 4.9 5.0 23.9 23.8 - - 80 0 -
6/4/2021 01:15:00 5.2 5.0 23.9 23.7 - - 80 0 -
6/4/2021 01:16:00 4.8 5.0 23.9 23.7 - - 80 0 -
6/4/2021 01:17:00 5.2 5.0 23.8 23.7 - - 80 0 -
6/4/2021 01:18:00 4.8 5.0 23.8 23.7 - - 80 0 -
6/4/2021 01:19:00 5.2 5.0 23.8 23.6 - - 80 0 -
6/4/2021 01:20:00 4.8 5.0 23.8 23.6 - - 80 0 -
6/4/2021 01:21:00 5.2 5.0 23.7 23.6 - - 80 0 -
6/4/2021 01:22:00 4.8 5.0 23.7 23.6 - - 80 0 -
6/4/2021 01:23:00 5.2 5.0 23.7 23.6 - - 80 0 -
6/4/2021 01:24:00 4.9 5.0 23.6 23.5 - - 80 0 -
6/4/2021 01:25:00 5.2 5.0 23.6 23.5 - - 80 0 -
6/4/2021 01:26:00 4.9 5.0 23.6 23.5 - - 80 0 -
6/4/2021 01:27:00 5.2 5.0 23.6 23.5 - - 80 0 -
6/4/2021 01:28:00 4.9 5.0 23.6 23.5 - - 80 0 -
6/4/2021 01:29:00 5.2 5.0 23.6 23.4 - - 80 0 -
6/4/2021 01:30:00 4.9 5.0 23.5 23.4 - - 80 0 -
6/4/2021 01:31:00 5.2 5.0 23.5 23.4 - - 80 0 -
6/4/2021 01:32:00 4.9 5.0 23.5 23.4 - - 80 0 -

-------------------------------------------
Approved by Date Page: 23 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 01:33:00 5.2 5.0 23.5 23.4 - - 80 0 -
6/4/2021 01:34:00 4.8 5.0 23.4 23.3 - - 80 0 -
6/4/2021 01:35:00 5.2 5.0 23.4 23.3 - - 80 0 -
6/4/2021 01:36:00 4.9 5.0 23.4 23.3 - - 80 0 -
6/4/2021 01:37:00 5.2 5.0 23.4 23.3 - - 80 0 -
6/4/2021 01:38:00 4.7 5.0 23.4 23.2 - - 80 0 -
6/4/2021 01:39:00 5.2 5.0 23.3 23.2 - - 80 0 -
6/4/2021 01:40:00 4.9 5.0 23.3 23.2 - - 80 0 -
6/4/2021 01:41:00 5.2 5.0 23.3 23.2 - - 80 0 -
6/4/2021 01:42:00 4.8 5.0 23.2 23.1 - - 80 0 -
6/4/2021 01:43:00 5.2 5.0 23.2 23.2 - - 80 0 -
6/4/2021 01:44:00 4.9 5.0 23.2 23.1 - - 80 0 -
6/4/2021 01:45:00 5.2 5.0 23.2 23.1 - - 80 0 -
6/4/2021 01:46:00 4.8 5.0 23.2 23.0 - - 80 0 -
6/4/2021 01:47:00 5.2 5.0 23.2 23.0 - - 80 0 -
6/4/2021 01:48:00 4.9 5.0 23.1 23.0 - - 80 0 -
6/4/2021 01:49:00 5.2 5.0 23.1 23.0 - - 80 0 -
6/4/2021 01:50:00 4.9 5.0 23.1 23.0 - - 80 0 -
6/4/2021 01:51:00 5.2 5.0 23.1 23.0 - - 80 0 -
6/4/2021 01:52:00 4.9 5.0 23.0 23.0 - - 80 0 -
6/4/2021 01:53:00 5.2 5.0 23.0 22.9 - - 80 0 -
6/4/2021 01:54:00 4.9 5.0 23.0 22.9 - - 80 0 -
6/4/2021 01:55:00 5.2 5.0 23.0 22.8 - - 80 0 -
6/4/2021 01:56:00 4.9 5.0 23.0 22.8 - - 80 0 -
6/4/2021 01:57:00 5.2 5.0 22.9 22.8 - - 80 0 -
6/4/2021 01:58:00 4.7 5.0 22.9 22.8 - - 80 0 -
6/4/2021 01:59:00 5.2 5.0 22.9 22.8 - - 80 0 -

-------------------------------------------
Approved by Date Page: 24 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 02:00:00 4.8 5.0 22.8 22.8 - - 80 0 -
6/4/2021 02:01:00 5.1 5.0 22.8 22.7 - - 80 0 -
6/4/2021 02:02:00 4.7 5.0 22.8 22.7 - - 80 0 -
6/4/2021 02:03:00 5.1 5.0 22.8 22.7 - - 80 0 -
6/4/2021 02:04:00 5.0 5.0 22.8 22.7 - - 80 0 -
6/4/2021 02:05:00 5.2 5.0 22.8 22.6 - - 80 0 -
6/4/2021 02:06:00 4.9 5.0 22.7 22.6 - - 80 0 -
6/4/2021 02:07:00 5.2 5.0 22.7 22.6 - - 80 0 -
6/4/2021 02:08:00 4.9 5.0 22.7 22.6 - - 80 0 -
6/4/2021 02:09:00 5.1 5.0 22.6 22.6 - - 80 0 -
6/4/2021 02:10:00 5.0 5.0 22.7 22.6 - - 80 0 -
6/4/2021 02:11:00 5.2 5.0 22.6 22.5 - - 80 0 -
6/4/2021 02:12:00 4.8 5.0 22.6 22.5 - - 80 0 -
6/4/2021 02:13:00 5.2 5.0 22.6 22.5 - - 80 0 -
6/4/2021 02:14:00 5.3 5.0 22.6 22.5 - - 80 0 -
6/4/2021 02:15:00 4.9 5.0 22.5 22.4 - - 80 0 -
6/4/2021 02:16:00 5.2 5.0 22.5 22.4 - - 80 0 -
6/4/2021 02:17:00 4.7 5.0 22.5 22.4 - - 80 0 -
6/4/2021 02:18:00 5.1 5.0 22.4 22.4 - - 80 0 -
6/4/2021 02:19:00 5.2 5.0 22.4 22.4 - - 80 0 -
6/4/2021 02:20:00 5.3 5.0 22.4 22.3 - - 80 0 -
6/4/2021 02:21:00 5.3 5.0 22.4 22.4 - - 80 0 -
6/4/2021 02:22:00 5.3 5.0 22.4 22.3 - - 80 0 -
6/4/2021 02:23:00 5.0 5.0 22.4 22.2 - - 80 0 -
6/4/2021 02:24:00 5.2 5.0 22.3 22.2 - - 80 0 -
6/4/2021 02:25:00 4.8 5.0 22.3 22.2 - - 80 0 -
6/4/2021 02:26:00 5.2 5.0 22.3 22.2 - - 80 0 -

-------------------------------------------
Approved by Date Page: 25 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 02:27:00 5.3 5.0 22.2 22.2 - - 80 0 -
6/4/2021 02:28:00 5.0 5.0 22.2 22.2 - - 80 0 -
6/4/2021 02:29:00 5.1 5.0 22.2 22.1 - - 80 0 -
6/4/2021 02:30:00 4.7 5.0 22.2 22.1 - - 80 0 -
6/4/2021 02:31:00 4.7 5.0 22.2 22.1 - - 80 0 -
6/4/2021 02:32:00 5.2 5.0 22.2 22.0 - - 80 0 -
6/4/2021 02:33:00 5.3 5.0 22.2 22.0 - - 80 0 -
6/4/2021 02:34:00 5.3 5.0 22.2 22.0 - - 80 0 -
6/4/2021 02:35:00 5.3 5.0 22.1 22.0 - - 80 0 -
6/4/2021 02:36:00 4.9 5.0 22.1 22.0 - - 80 0 -
6/4/2021 02:37:00 5.2 5.0 22.1 22.0 - - 80 0 -
6/4/2021 02:38:00 5.0 5.0 22.1 22.0 - - 80 0 -
6/4/2021 02:39:00 5.1 5.0 22.0 21.9 - - 80 0 -
6/4/2021 02:40:00 5.2 5.0 22.0 21.9 - - 80 0 -
6/4/2021 02:41:00 4.9 5.0 22.0 21.9 - - 80 0 -
6/4/2021 02:42:00 5.1 5.0 21.9 21.8 - - 80 0 -
6/4/2021 02:43:00 4.9 5.0 21.9 21.8 - - 80 0 -
6/4/2021 02:44:00 5.1 5.0 21.9 21.8 - - 80 0 -
6/4/2021 02:45:00 5.0 5.0 21.9 21.8 - - 80 0 -
6/4/2021 02:46:00 5.2 5.0 21.9 21.8 - - 80 0 -
6/4/2021 02:47:00 4.9 5.0 21.9 21.8 - - 80 0 -
6/4/2021 02:48:00 5.1 5.0 21.8 21.7 - - 80 0 -
6/4/2021 02:49:00 4.9 5.0 21.8 21.7 - - 80 0 -
6/4/2021 02:50:00 5.1 5.0 21.8 21.7 - - 80 0 -
6/4/2021 02:51:00 5.0 5.0 21.8 21.7 - - 80 0 -
6/4/2021 02:52:00 5.1 5.0 21.7 21.6 - - 80 0 -
6/4/2021 02:53:00 5.1 5.0 21.7 21.6 - - 80 0 -

-------------------------------------------
Approved by Date Page: 26 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 02:54:00 5.1 5.0 21.7 21.6 - - 80 0 -
6/4/2021 02:55:00 5.1 5.0 21.7 21.6 - - 80 0 -
6/4/2021 02:56:00 5.1 5.0 21.7 21.6 - - 80 0 -
6/4/2021 02:57:00 5.0 5.0 21.6 21.5 - - 80 0 -
6/4/2021 02:58:00 5.1 5.0 21.6 21.5 - - 80 0 -
6/4/2021 02:59:00 4.7 5.0 21.6 21.5 - - 80 0 -
6/4/2021 03:00:00 4.5 5.0 21.6 21.5 - - 80 0 -
6/4/2021 03:01:00 4.9 5.0 21.6 21.4 - - 80 0 -
6/4/2021 03:02:00 5.2 5.0 21.5 21.4 - - 80 0 -
6/4/2021 03:03:00 5.0 5.0 21.5 21.4 - - 80 0 -
6/4/2021 03:04:00 5.1 5.0 21.5 21.4 - - 80 0 -
6/4/2021 03:05:00 4.7 5.0 21.5 21.4 - - 80 0 -
6/4/2021 03:06:00 5.2 5.0 21.5 21.4 - - 80 0 -
6/4/2021 03:07:00 4.9 5.0 21.4 21.4 - - 80 0 -
6/4/2021 03:08:00 5.1 5.0 21.4 21.4 - - 80 0 -
6/4/2021 03:09:00 4.8 5.0 21.4 21.3 - - 80 0 -
6/4/2021 03:10:00 5.1 5.0 21.4 21.2 - - 80 0 -
6/4/2021 03:11:00 5.0 5.0 21.3 21.2 - - 80 0 -
6/4/2021 03:12:00 5.2 5.0 21.3 21.2 - - 80 0 -
6/4/2021 03:13:00 4.9 5.0 21.3 21.2 - - 80 0 -
6/4/2021 03:14:00 5.1 5.0 21.3 21.2 - - 80 0 -
6/4/2021 03:15:00 4.9 5.0 21.3 21.2 - - 80 0 -
6/4/2021 03:16:00 5.2 5.0 21.2 21.2 - - 80 0 -
6/4/2021 03:17:00 4.9 5.0 21.2 21.1 - - 80 0 -
6/4/2021 03:18:00 5.2 5.0 21.2 21.1 - - 80 0 -
6/4/2021 03:19:00 4.9 5.0 21.2 21.1 - - 80 0 -
6/4/2021 03:20:00 5.2 5.0 21.1 21.1 - - 80 0 -

-------------------------------------------
Approved by Date Page: 27 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 03:21:00 4.9 5.0 21.1 21.1 - - 80 0 -
6/4/2021 03:22:00 5.2 5.0 21.1 21.0 - - 80 0 -
6/4/2021 03:23:00 4.9 5.0 21.1 21.0 - - 80 0 -
6/4/2021 03:24:00 5.2 5.0 21.1 21.0 - - 80 0 -
6/4/2021 03:25:00 4.9 5.0 21.1 21.0 - - 80 0 -
6/4/2021 03:26:00 5.2 5.0 21.0 21.0 - - 80 0 -
6/4/2021 03:27:00 4.9 5.0 21.0 20.9 - - 80 0 -
6/4/2021 03:28:00 5.2 5.0 21.0 20.9 - - 80 0 -
6/4/2021 03:29:00 4.9 5.0 21.0 20.9 - - 80 0 -
6/4/2021 03:30:00 5.2 5.0 20.9 20.9 - - 80 0 -
6/4/2021 03:31:00 4.7 5.0 20.9 20.9 - - 80 0 -
6/4/2021 03:32:00 5.2 5.0 20.9 20.8 - - 80 0 -
6/4/2021 03:33:00 4.9 5.0 20.9 20.8 - - 80 0 -
6/4/2021 03:34:00 5.2 5.0 20.9 20.8 - - 80 0 -
6/4/2021 03:35:00 4.8 5.0 20.9 20.8 - - 80 0 -
6/4/2021 03:36:00 5.2 5.0 20.8 20.8 - - 80 0 -
6/4/2021 03:37:00 4.9 5.0 20.8 20.8 - - 80 0 -
6/4/2021 03:38:00 5.2 5.0 20.8 20.7 - - 80 0 -
6/4/2021 03:39:00 4.8 5.0 20.8 20.7 - - 80 0 -
6/4/2021 03:40:00 5.2 5.0 20.8 20.7 - - 80 0 -
6/4/2021 03:41:00 4.7 5.0 20.7 20.7 - - 80 0 -
6/4/2021 03:42:00 5.2 5.0 20.7 20.6 - - 80 0 -
6/4/2021 03:43:00 4.8 5.0 20.7 20.6 - - 80 0 -
6/4/2021 03:44:00 5.2 5.0 20.7 20.6 - - 80 0 -
6/4/2021 03:45:00 4.8 5.0 20.6 20.6 - - 80 0 -
6/4/2021 03:46:00 5.2 5.0 20.6 20.6 - - 80 0 -
6/4/2021 03:47:00 4.8 5.0 20.6 20.6 - - 80 0 -

-------------------------------------------
Approved by Date Page: 28 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 03:48:00 5.2 5.0 20.6 20.5 - - 80 0 -
6/4/2021 03:49:00 4.8 5.0 20.6 20.5 - - 80 0 -
6/4/2021 03:50:00 5.2 5.0 20.6 20.5 - - 80 0 -
6/4/2021 03:51:00 4.8 5.0 20.6 20.4 - - 80 0 -
6/4/2021 03:52:00 5.2 5.0 20.5 20.4 - - 80 0 -
6/4/2021 03:53:00 5.0 5.0 20.5 20.4 - - 80 0 -
6/4/2021 03:54:00 5.2 5.0 20.5 20.4 - - 80 0 -
6/4/2021 03:55:00 4.9 5.0 20.4 20.4 - - 80 0 -
6/4/2021 03:56:00 5.2 5.0 20.4 20.4 - - 80 0 -
6/4/2021 03:57:00 4.8 5.0 20.4 20.4 - - 80 0 -
6/4/2021 03:58:00 5.2 5.0 20.4 20.3 - - 80 0 -
6/4/2021 03:59:00 5.0 5.0 20.4 20.3 - - 80 0 -
6/4/2021 04:00:00 5.2 5.0 20.3 20.3 - - 80 0 -
6/4/2021 04:01:00 4.8 5.0 20.4 20.3 - - 80 0 -
6/4/2021 04:02:00 5.2 5.0 20.3 20.2 - - 80 0 -
6/4/2021 04:03:00 4.9 5.0 20.3 20.2 - - 80 0 -
6/4/2021 04:04:00 5.2 5.0 20.3 20.2 - - 80 0 -
6/4/2021 04:05:00 4.8 5.0 20.2 20.2 - - 80 0 -
6/4/2021 04:06:00 5.2 5.0 20.2 20.2 - - 80 0 -
6/4/2021 04:07:00 5.0 5.0 20.2 20.1 - - 80 0 -
6/4/2021 04:08:00 5.2 5.0 20.2 20.1 - - 80 0 -
6/4/2021 04:09:00 4.8 5.0 20.2 20.1 - - 80 0 -
6/4/2021 04:10:00 5.2 5.0 20.2 20.1 - - 80 0 -
6/4/2021 04:11:00 4.9 5.0 20.1 20.1 - - 80 0 -
6/4/2021 04:12:00 5.2 5.0 20.1 20.1 - - 80 0 -
6/4/2021 04:13:00 4.8 5.0 20.1 20.0 - - 80 0 -
6/4/2021 04:14:00 5.3 5.0 20.1 20.0 - - 80 0 -

-------------------------------------------
Approved by Date Page: 29 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 04:15:00 4.9 5.0 20.1 20.0 - - 80 0 -
6/4/2021 04:16:00 5.3 5.0 20.1 20.0 - - 80 0 -
6/4/2021 04:17:00 4.9 5.0 20.0 20.0 - - 80 0 -
6/4/2021 04:18:00 5.2 5.0 20.0 19.9 - - 80 0 -
6/4/2021 04:19:00 4.7 5.0 20.0 19.9 - - 80 0 -
6/4/2021 04:20:00 5.2 5.0 20.0 19.9 - - 80 0 -
6/4/2021 04:21:00 4.8 5.0 20.0 19.9 - - 80 0 -
6/4/2021 04:22:00 5.2 5.0 19.9 19.9 - - 80 0 -
6/4/2021 04:23:00 4.8 5.0 19.9 19.8 - - 80 0 -
6/4/2021 04:24:00 5.2 5.0 19.9 19.8 - - 80 0 -
6/4/2021 04:25:00 4.8 5.0 19.9 19.8 - - 80 0 -
6/4/2021 04:26:00 5.2 5.0 19.8 19.8 - - 80 0 -
6/4/2021 04:27:00 4.8 5.0 19.8 19.8 - - 80 0 -
6/4/2021 04:28:00 5.2 5.0 19.9 19.8 - - 80 0 -
6/4/2021 04:29:00 5.0 5.0 19.8 19.7 - - 80 0 -
6/4/2021 04:30:00 5.2 5.0 19.8 19.7 - - 80 0 -
6/4/2021 04:31:00 4.9 5.0 19.8 19.7 - - 80 0 -
6/4/2021 04:32:00 5.2 5.0 19.8 19.7 - - 80 0 -
6/4/2021 04:33:00 4.8 5.0 19.7 19.7 - - 80 0 -
6/4/2021 04:34:00 5.2 5.0 19.7 19.6 - - 80 0 -
6/4/2021 04:35:00 5.0 5.0 19.7 19.6 - - 80 0 -
6/4/2021 04:36:00 5.2 5.0 19.7 19.6 - - 80 0 -
6/4/2021 04:37:00 4.8 5.0 19.7 19.6 - - 80 0 -
6/4/2021 04:38:00 5.2 5.0 19.6 19.6 - - 80 0 -
6/4/2021 04:39:00 4.9 5.0 19.6 19.5 - - 80 0 -
6/4/2021 04:40:00 5.2 5.0 19.6 19.5 - - 80 0 -
6/4/2021 04:41:00 4.8 5.0 19.6 19.5 - - 80 0 -

-------------------------------------------
Approved by Date Page: 30 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 04:42:00 5.2 5.0 19.5 19.5 - - 80 0 -
6/4/2021 04:43:00 4.8 5.0 19.5 19.5 - - 80 0 -
6/4/2021 04:44:00 5.2 5.0 19.5 19.5 - - 80 0 -
6/4/2021 04:45:00 4.8 5.0 19.5 19.5 - - 80 0 -
6/4/2021 04:46:00 5.2 5.0 19.5 19.4 - - 80 0 -
6/4/2021 04:47:00 4.8 5.0 19.5 19.4 - - 80 0 -
6/4/2021 04:48:00 5.2 5.0 19.5 19.4 - - 80 0 -
6/4/2021 04:49:00 4.8 5.0 19.4 19.4 - - 80 0 -
6/4/2021 04:50:00 5.3 5.0 19.4 19.4 - - 80 0 -
6/4/2021 04:51:00 4.9 5.0 19.4 19.3 - - 80 0 -
6/4/2021 04:52:00 5.2 5.0 19.4 19.3 - - 80 0 -
6/4/2021 04:53:00 4.8 5.0 19.4 19.3 - - 80 0 -
6/4/2021 04:54:00 5.2 5.0 19.3 19.3 - - 80 0 -
6/4/2021 04:55:00 4.8 5.0 19.3 19.3 - - 80 0 -
6/4/2021 04:56:00 5.2 5.0 19.3 19.3 - - 80 0 -
6/4/2021 04:57:00 4.8 5.0 19.2 19.2 - - 80 0 -
6/4/2021 04:58:00 5.2 5.0 19.3 19.2 - - 80 0 -
6/4/2021 04:59:00 5.0 5.0 19.2 19.2 - - 80 0 -
6/4/2021 05:00:00 5.2 5.0 19.2 19.2 - - 80 0 -
6/4/2021 05:01:00 4.5 5.0 19.2 19.2 - - 80 0 -
6/4/2021 05:02:00 5.2 5.0 19.2 19.1 - - 80 0 -
6/4/2021 05:03:00 4.8 5.0 19.2 19.1 - - 80 0 -
6/4/2021 05:04:00 5.2 5.0 19.2 19.1 - - 80 0 -
6/4/2021 05:05:00 4.9 5.0 19.1 19.1 - - 80 0 -
6/4/2021 05:06:00 5.2 5.0 19.1 19.1 - - 80 0 -
6/4/2021 05:07:00 4.9 5.0 19.1 19.0 - - 80 0 -
6/4/2021 05:08:00 5.2 5.0 19.1 19.0 - - 80 0 -

-------------------------------------------
Approved by Date Page: 31 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 05:09:00 4.8 5.0 19.1 19.0 - - 80 0 -
6/4/2021 05:10:00 5.1 5.0 19.0 19.0 - - 80 0 -
6/4/2021 05:11:00 4.9 5.0 19.0 19.0 - - 80 0 -
6/4/2021 05:12:00 5.2 5.0 19.0 19.0 - - 80 0 -
6/4/2021 05:12:29 Audit: - A_SQLCOMMFAIL ALARM is acknowledged by IDIN.
6/4/2021 05:12:40 Audit: - The freeze drying cycle is advanced to the next step by IDIN.
Event: - Auto freeze drying advanced to next step.
6/4/2021 05:12:41 Event: - Step advanced to [2] Freezing
6/4/2021 05:13:00 4.9 5.0 19.0 19.0 - - 80 0 -
6/4/2021 05:14:00 5.2 5.0 19.0 18.9 - - 80 0 -
6/4/2021 05:15:00 4.9 5.0 19.0 19.0 - - 80 0 -
6/4/2021 05:16:00 5.1 5.0 19.0 18.9 - - 80 0 -
6/4/2021 05:17:00 4.7 5.0 18.9 18.9 - - 80 0 -
6/4/2021 05:18:00 5.1 5.0 18.9 18.9 - - 80 0 -
6/4/2021 05:19:00 4.7 5.0 18.9 18.8 - - 80 0 -
6/4/2021 05:20:00 5.2 5.0 18.9 18.9 - - 80 0 -
6/4/2021 05:21:00 5.0 5.0 18.9 18.8 - - 80 0 -
6/4/2021 05:22:00 5.1 5.0 18.8 18.7 - - 80 0 -
6/4/2021 05:23:00 4.7 5.0 18.8 18.8 - - 80 0 -
6/4/2021 05:24:00 5.2 5.0 18.8 18.8 - - 80 0 -
6/4/2021 05:25:00 5.0 5.0 18.8 18.7 - - 80 0 -
6/4/2021 05:26:00 5.2 5.0 18.7 18.7 - - 80 0 -
6/4/2021 05:27:00 4.9 5.0 18.7 18.7 - - 80 0 -
6/4/2021 05:28:00 5.2 5.0 18.7 18.7 - - 80 0 -
6/4/2021 05:29:00 4.9 5.0 18.7 18.7 - - 80 0 -
6/4/2021 05:30:00 5.1 5.0 18.7 18.7 - - 80 0 -
6/4/2021 05:31:00 4.9 5.0 18.7 18.6 - - 80 0 -

-------------------------------------------
Approved by Date Page: 32 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 05:32:00 5.2 5.0 18.7 18.6 - - 80 0 -
6/4/2021 05:33:00 4.9 5.0 18.6 18.6 - - 80 0 -
6/4/2021 05:34:00 5.2 5.0 18.6 18.6 - - 80 0 -
6/4/2021 05:35:00 4.9 5.0 18.6 18.5 - - 80 0 -
6/4/2021 05:36:00 5.2 5.0 18.5 18.5 - - 80 0 -
6/4/2021 05:37:00 4.9 5.0 18.5 18.5 - - 80 0 -
6/4/2021 05:38:00 5.1 5.0 18.5 18.5 - - 80 0 -
6/4/2021 05:39:00 4.8 5.0 18.5 18.5 - - 80 0 -
6/4/2021 05:40:00 5.1 5.0 18.5 18.5 - - 80 0 -
6/4/2021 05:41:00 4.9 5.0 18.5 18.4 - - 80 0 -
6/4/2021 05:42:00 5.1 5.0 18.5 18.4 - - 80 0 -
6/4/2021 05:42:40 Event: - Step advanced to [3] Freezing
6/4/2021 05:43:00 4.8 4.8 18.5 18.4 - - 80 0 -
6/4/2021 05:44:00 5.0 4.4 18.4 18.4 - - 80 0 -
6/4/2021 05:45:00 3.5 3.8 18.4 18.4 - - 80 0 -
6/4/2021 05:46:00 4.3 3.4 18.4 18.4 - - 80 0 -
6/4/2021 05:47:00 2.4 2.8 18.3 18.4 - - 80 0 -
6/4/2021 05:48:00 2.9 2.4 18.4 18.4 - - 80 0 -
6/4/2021 05:49:00 1.4 1.8 18.4 18.4 - - 80 0 -
6/4/2021 05:50:00 1.8 1.4 18.3 18.3 - - 80 0 -
6/4/2021 05:51:00 0.7 0.8 18.3 18.3 - - 80 0 -
6/4/2021 05:52:00 0.1 0.4 18.3 18.3 - - 80 0 -
6/4/2021 05:53:00 -0.3 -0.2 18.3 18.3 - - 80 0 -
6/4/2021 05:54:00 -0.6 -0.6 18.3 18.3 - - 80 0 -
6/4/2021 05:55:00 -1.4 -1.2 18.3 18.2 - - 80 0 -
6/4/2021 05:56:00 -1.7 -1.6 18.2 18.2 - - 80 0 -
6/4/2021 05:57:00 -2.2 -2.2 18.2 18.2 - - 80 0 -

-------------------------------------------
Approved by Date Page: 33 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 05:58:00 -2.7 -2.6 18.2 18.2 - - 80 0 -
6/4/2021 05:59:00 -3.6 -3.2 18.2 18.2 - - 80 0 -
6/4/2021 06:00:00 -3.7 -3.6 18.2 18.1 - - 80 0 -
6/4/2021 06:01:00 -4.3 -4.2 18.2 18.1 - - 80 0 -
6/4/2021 06:02:00 -4.8 -4.6 18.1 18.1 - - 80 0 -
6/4/2021 06:03:00 -5.6 -5.2 18.1 18.1 - - 80 0 -
6/4/2021 06:04:00 -5.8 -5.6 18.1 18.1 - - 80 0 -
6/4/2021 06:05:00 -6.5 -6.2 18.1 18.1 - - 80 0 -
6/4/2021 06:06:00 -7.0 -6.6 18.0 18.1 - - 80 0 -
6/4/2021 06:07:00 -7.8 -7.2 18.1 18.0 - - 80 0 -
6/4/2021 06:08:00 -7.7 -7.6 18.1 18.0 - - 80 0 -
6/4/2021 06:09:00 -8.6 -8.2 18.0 18.0 - - 80 0 -
6/4/2021 06:10:00 -9.0 -8.6 18.0 18.0 - - 80 0 -
6/4/2021 06:11:00 -9.7 -9.2 18.0 18.0 - - 80 0 -
6/4/2021 06:12:00 -9.9 -9.6 17.9 18.0 - - 80 0 -
6/4/2021 06:13:00 -10.8 -10.2 17.9 18.0 - - 80 0 -
6/4/2021 06:14:00 -11.0 -10.6 17.9 17.9 - - 80 0 -
6/4/2021 06:15:00 -11.6 -11.2 17.9 17.9 - - 80 0 -
6/4/2021 06:16:00 -12.0 -11.6 17.9 17.9 - - 80 0 -
6/4/2021 06:17:00 -12.6 -12.2 17.9 17.9 - - 80 0 -
6/4/2021 06:18:00 -12.9 -12.6 17.9 17.9 - - 80 0 -
6/4/2021 06:19:00 -13.5 -13.2 17.9 17.9 - - 80 0 -
6/4/2021 06:20:00 -14.0 -13.6 17.9 17.9 - - 80 0 -
6/4/2021 06:21:00 -14.4 -14.2 17.8 17.8 - - 80 0 -
6/4/2021 06:22:00 -14.9 -14.6 17.8 17.8 - - 80 0 -
6/4/2021 06:23:00 -15.4 -15.2 17.8 17.8 - - 80 0 -
6/4/2021 06:24:00 -15.9 -15.6 17.8 17.8 - - 80 0 -

-------------------------------------------
Approved by Date Page: 34 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 06:25:00 -16.4 -16.2 17.7 17.7 - - 80 0 -
6/4/2021 06:26:00 -16.8 -16.6 17.8 17.7 - - 80 0 -
6/4/2021 06:27:00 -17.3 -17.2 17.7 17.7 - - 80 0 -
6/4/2021 06:28:00 -17.7 -17.6 17.7 17.7 - - 80 0 -
6/4/2021 06:29:00 -18.2 -18.2 17.7 17.7 - - 80 0 -
6/4/2021 06:30:00 -18.7 -18.6 17.7 17.7 - - 80 0 -
6/4/2021 06:31:00 -19.1 -19.2 17.6 17.7 - - 80 0 -
6/4/2021 06:32:00 -19.6 -19.6 17.6 17.7 - - 80 0 -
6/4/2021 06:33:00 -20.1 -20.2 17.6 17.6 - - 80 0 -
6/4/2021 06:34:00 -20.5 -20.6 17.6 17.7 - - 80 0 -
6/4/2021 06:35:00 -21.0 -21.2 17.6 17.6 - - 80 0 -
6/4/2021 06:36:00 -21.5 -21.6 17.6 17.6 - - 80 0 -
6/4/2021 06:37:00 -22.0 -22.2 17.6 17.6 - - 80 0 -
6/4/2021 06:38:00 -22.5 -22.6 17.5 17.6 - - 80 0 -
6/4/2021 06:39:00 -23.0 -23.2 17.5 17.6 - - 80 0 -
6/4/2021 06:40:00 -23.4 -23.6 17.5 17.5 - - 80 0 -
6/4/2021 06:41:00 -23.9 -24.2 17.5 17.5 - - 80 0 -
6/4/2021 06:42:00 -24.3 -24.6 17.5 17.5 - - 80 0 -
6/4/2021 06:43:00 -24.7 -25.2 17.5 17.5 - - 80 0 -
6/4/2021 06:44:00 -25.1 -25.6 17.5 17.5 - - 80 0 -
6/4/2021 06:45:00 -25.5 -26.2 17.5 17.5 - - 80 0 -
6/4/2021 06:46:00 -25.8 -26.6 17.5 17.5 - - 80 0 -
6/4/2021 06:47:00 -26.1 -27.2 17.5 17.5 - - 80 0 -
6/4/2021 06:48:00 -26.9 -27.6 17.4 17.5 - - 80 0 -
6/4/2021 06:49:00 -27.8 -28.2 17.4 17.4 - - 80 0 -
6/4/2021 06:50:00 -28.5 -28.6 17.4 17.4 - - 80 0 -
6/4/2021 06:51:00 -29.2 -29.2 17.4 17.4 - - 80 0 -

-------------------------------------------
Approved by Date Page: 35 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 06:52:00 -29.6 -29.6 17.3 17.4 - - 80 0 -
6/4/2021 06:53:00 -30.5 -30.2 17.4 17.4 - - 80 0 -
6/4/2021 06:54:00 -30.8 -30.6 17.3 17.3 - - 80 0 -
6/4/2021 06:55:00 -31.1 -31.2 17.3 17.3 - - 80 0 -
6/4/2021 06:56:00 -31.6 -31.6 17.3 17.3 - - 80 0 -
6/4/2021 06:57:00 -32.3 -32.2 17.3 17.3 - - 80 0 -
6/4/2021 06:58:00 -32.7 -32.6 17.3 17.3 - - 80 0 -
6/4/2021 06:59:00 -33.1 -33.2 17.3 17.3 - - 80 0 -
6/4/2021 07:00:00 -33.6 -33.6 17.3 17.3 - - 80 0 -
6/4/2021 07:01:00 -34.0 -34.2 17.2 17.2 - - 80 0 -
6/4/2021 07:02:00 -34.3 -34.6 17.2 17.3 - - 80 0 -
6/4/2021 07:03:00 -34.8 -35.2 17.2 17.3 - - 80 0 -
6/4/2021 07:04:00 -35.0 -35.6 17.2 17.3 - - 80 0 -
6/4/2021 07:05:00 -35.6 -36.2 17.2 17.2 - - 80 0 -
6/4/2021 07:06:00 -35.9 -36.6 17.2 17.2 - - 80 0 -
6/4/2021 07:07:00 -36.3 -37.2 17.1 17.2 - - 80 0 -
6/4/2021 07:08:00 -36.7 -37.6 17.2 17.2 - - 80 0 -
6/4/2021 07:09:00 -37.0 -38.2 17.1 17.2 - - 80 0 -
6/4/2021 07:10:00 -37.3 -38.6 17.1 17.2 - - 80 0 -
6/4/2021 07:11:00 -37.6 -39.2 17.1 17.1 - - 80 0 -
6/4/2021 07:12:00 -37.9 -39.6 17.1 17.1 - - 80 0 -
6/4/2021 07:13:00 -37.9 -40.2 17.1 17.1 - - 80 0 -
6/4/2021 07:14:00 -38.1 -40.6 17.1 17.1 - - 80 0 -
6/4/2021 07:15:00 -38.5 -41.2 17.0 17.1 - - 80 0 -
6/4/2021 07:16:00 -38.8 -41.6 17.0 17.0 - - 80 0 -
6/4/2021 07:17:00 -39.3 -42.2 17.0 17.1 - - 80 0 -
6/4/2021 07:18:00 -39.8 -42.6 17.0 17.0 - - 80 0 -

-------------------------------------------
Approved by Date Page: 36 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 07:19:00 -40.2 -43.2 17.0 17.0 - - 80 0 -
6/4/2021 07:20:00 -40.6 -43.6 17.0 17.0 - - 80 0 -
6/4/2021 07:21:00 -41.1 -44.2 17.0 17.0 - - 80 0 -
6/4/2021 07:22:00 -41.5 -44.6 16.9 17.0 - - 80 0 -
6/4/2021 07:22:40 Event: - Auto freeze cycle hold mode activated.
6/4/2021 07:23:00 -42.0 -45.0 16.9 16.9 - - 80 0 -
6/4/2021 07:24:00 -42.4 -45.0 16.9 17.0 - - 80 0 -
6/4/2021 07:25:00 -42.9 -45.0 16.9 17.0 - - 80 0 -
6/4/2021 07:26:00 -43.3 -45.0 16.8 16.9 - - 80 0 -
6/4/2021 07:27:00 -43.7 -45.0 16.8 16.9 - - 80 0 -
6/4/2021 07:27:50 Event: - Step advanced to [4] Freezing
6/4/2021 07:27:55 Event: - Auto freeze cycle hold mode exited.
6/4/2021 07:28:00 -44.1 -45.0 16.9 16.9 - - 80 0 -
6/4/2021 07:29:00 -44.5 -45.0 16.8 16.9 - - 80 0 -
6/4/2021 07:30:00 -44.9 -45.0 16.8 16.9 - - 80 0 -
6/4/2021 07:31:00 -45.2 -45.0 16.8 16.8 - - 80 0 -
6/4/2021 07:32:00 -45.6 -45.0 16.8 16.8 - - 80 0 -
6/4/2021 07:33:00 -45.7 -45.0 16.8 16.8 - - 80 0 -
6/4/2021 07:34:00 -45.5 -45.0 16.8 16.8 - - 80 0 -
6/4/2021 07:35:00 -45.6 -45.0 16.7 16.8 - - 80 0 -
6/4/2021 07:36:00 -44.8 -45.0 16.7 16.8 - - 80 0 -
6/4/2021 07:37:00 -45.0 -45.0 16.7 16.8 - - 80 0 -
6/4/2021 07:38:00 -45.1 -45.0 16.7 16.8 - - 80 0 -
6/4/2021 07:39:00 -44.8 -45.0 16.7 16.8 - - 80 0 -
6/4/2021 07:40:00 -45.5 -45.0 16.7 16.7 - - 80 0 -
6/4/2021 07:41:00 -44.8 -45.0 16.6 16.7 - - 80 0 -
6/4/2021 07:42:00 -45.2 -45.0 16.6 16.7 - - 80 0 -

-------------------------------------------
Approved by Date Page: 37 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 07:43:00 -45.1 -45.0 16.7 16.7 - - 80 0 -
6/4/2021 07:44:00 -44.9 -45.0 16.6 16.7 - - 80 0 -
6/4/2021 07:45:00 -45.2 -45.0 16.6 16.6 - - 80 0 -
6/4/2021 07:46:00 -44.9 -45.0 16.6 16.6 - - 80 0 -
6/4/2021 07:47:00 -45.1 -45.0 16.5 16.6 - - 80 0 -
6/4/2021 07:48:00 -44.9 -45.0 16.6 16.6 - - 80 0 -
6/4/2021 07:49:00 -44.9 -45.0 16.5 16.6 - - 80 0 -
6/4/2021 07:50:00 -45.3 -45.0 16.6 16.6 - - 80 0 -
6/4/2021 07:51:00 -45.0 -45.0 16.5 16.6 - - 80 0 -
6/4/2021 07:52:00 -45.0 -45.0 16.5 16.6 - - 80 0 -
6/4/2021 07:53:00 -45.0 -45.0 16.5 16.5 - - 80 0 -
6/4/2021 07:54:00 -45.0 -45.0 16.4 16.5 - - 80 0 -
6/4/2021 07:55:00 -45.0 -45.0 16.5 16.5 - - 80 0 -
6/4/2021 07:56:00 -45.0 -45.0 16.4 16.5 - - 80 0 -
6/4/2021 07:57:00 -45.0 -45.0 16.4 16.5 - - 80 0 -
6/4/2021 07:58:00 -45.1 -45.0 16.4 16.5 - - 80 0 -
6/4/2021 07:59:00 -45.0 -45.0 16.4 16.4 - - 80 0 -
6/4/2021 08:00:00 -45.1 -45.0 16.4 16.4 - - 80 0 -
6/4/2021 08:01:00 -44.9 -45.0 16.4 16.4 - - 80 0 -
6/4/2021 08:02:00 -45.1 -45.0 16.3 16.4 - - 80 0 -
6/4/2021 08:02:31 Alarm: CLOSE - Communication fail with SQL database.
6/4/2021 08:03:00 -44.9 -45.0 16.3 16.4 - - 80 0 -
6/4/2021 08:04:00 -44.9 -45.0 16.3 16.4 - - 80 0 -
6/4/2021 08:05:00 -44.9 -45.0 16.3 16.4 - - 80 0 -
6/4/2021 08:06:00 -45.0 -45.0 16.3 16.4 - - 80 0 -
6/4/2021 08:07:00 -45.0 -45.0 16.3 16.3 - - 80 0 -
6/4/2021 08:08:00 -44.9 -45.0 16.3 16.3 - - 80 0 -

-------------------------------------------
Approved by Date Page: 38 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 08:09:00 -45.0 -45.0 16.3 16.3 - - 80 0 -
6/4/2021 08:10:00 -44.9 -45.0 16.2 16.3 - - 80 0 -
6/4/2021 08:11:00 -44.9 -45.0 16.2 16.3 - - 80 0 -
6/4/2021 08:12:00 -44.9 -45.0 16.2 16.3 - - 80 0 -
6/4/2021 08:13:00 -45.0 -45.0 16.2 16.3 - - 80 0 -
6/4/2021 08:14:00 -45.0 -45.0 16.2 16.2 - - 80 0 -
6/4/2021 08:15:00 -45.0 -45.0 16.2 16.2 - - 80 0 -
6/4/2021 08:16:00 -45.0 -45.0 16.2 16.2 - - 80 0 -
6/4/2021 08:17:00 -45.0 -45.0 16.1 16.2 - - 80 0 -
6/4/2021 08:18:00 -45.2 -45.0 16.1 16.2 - - 80 0 -
6/4/2021 08:19:00 -45.2 -45.0 16.1 16.2 - - 80 0 -
6/4/2021 08:20:00 -44.9 -45.0 16.1 16.2 - - 80 0 -
6/4/2021 08:21:00 -44.9 -45.0 16.1 16.2 - - 80 0 -
6/4/2021 08:22:00 -45.0 -45.0 16.0 16.1 - - 80 0 -
6/4/2021 08:23:00 -45.2 -45.0 16.0 16.1 - - 80 0 -
6/4/2021 08:24:00 -45.1 -45.0 16.0 16.1 - - 80 0 -
6/4/2021 08:25:00 -45.1 -45.0 16.0 16.1 - - 80 0 -
6/4/2021 08:26:00 -44.9 -45.0 16.0 16.1 - - 80 0 -
6/4/2021 08:27:00 -44.9 -45.0 16.0 16.1 - - 80 0 -
6/4/2021 08:28:00 -44.9 -45.0 16.0 16.0 - - 80 0 -
6/4/2021 08:29:00 -44.9 -45.0 16.0 16.0 - - 80 0 -
6/4/2021 08:30:00 -45.0 -45.0 15.9 16.0 - - 80 0 -
6/4/2021 08:31:00 -45.0 -45.0 16.0 16.0 - - 80 0 -
6/4/2021 08:32:00 -45.0 -45.0 15.9 16.0 - - 80 0 -
6/4/2021 08:33:00 -45.2 -45.0 15.9 16.0 - - 80 0 -
6/4/2021 08:34:00 -45.1 -45.0 15.9 16.0 - - 80 0 -
6/4/2021 08:35:00 -45.1 -45.0 15.9 16.0 - - 80 0 -

-------------------------------------------
Approved by Date Page: 39 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 08:36:00 -45.1 -45.0 15.9 15.9 - - 80 0 -
6/4/2021 08:37:00 -45.1 -45.0 15.8 15.9 - - 80 0 -
6/4/2021 08:38:00 -45.2 -45.0 15.8 15.9 - - 80 0 -
6/4/2021 08:39:00 -45.1 -45.0 15.8 15.9 - - 80 0 -
6/4/2021 08:40:00 -44.9 -45.0 15.8 15.9 - - 80 0 -
6/4/2021 08:41:00 -44.9 -45.0 15.8 15.9 - - 80 0 -
6/4/2021 08:42:00 -44.9 -45.0 15.8 15.9 - - 80 0 -
6/4/2021 08:43:00 -44.9 -45.0 15.8 15.8 - - 80 0 -
6/4/2021 08:44:00 -44.9 -45.0 15.8 15.8 - - 80 0 -
6/4/2021 08:45:00 -45.0 -45.0 15.7 15.8 - - 80 0 -
6/4/2021 08:46:00 -44.9 -45.0 15.7 15.8 - - 80 0 -
6/4/2021 08:47:00 -44.9 -45.0 15.7 15.8 - - 80 0 -
6/4/2021 08:48:00 -45.0 -45.0 15.7 15.8 - - 80 0 -
6/4/2021 08:49:00 -45.0 -45.0 15.7 15.8 - - 80 0 -
6/4/2021 08:50:00 -45.2 -45.0 15.7 15.7 - - 80 0 -
6/4/2021 08:51:00 -45.1 -45.0 15.7 15.7 - - 80 0 -
6/4/2021 08:52:00 -44.9 -45.0 15.6 15.7 - - 80 0 -
6/4/2021 08:53:00 -45.0 -45.0 15.6 15.7 - - 80 0 -
6/4/2021 08:54:00 -45.0 -45.0 15.6 15.7 - - 80 0 -
6/4/2021 08:55:00 -45.0 -45.0 15.6 15.6 - - 80 0 -
6/4/2021 08:56:00 -45.2 -45.0 15.6 15.7 - - 80 0 -
6/4/2021 08:57:00 -45.1 -45.0 15.6 15.6 - - 80 0 -
6/4/2021 08:57:45 Event: - Step advanced to [5] Evacuation
6/4/2021 08:58:00 -44.9 -45.0 15.6 15.6 - 200 230 170 -
6/4/2021 08:59:00 -44.9 -45.0 15.2 15.6 - 200 230 170 -
6/4/2021 09:00:00 -44.9 -45.0 10.2 15.4 - 200 230 170 -
6/4/2021 09:01:00 -44.8 -45.0 -25.7 15.2 - 200 230 170 -

-------------------------------------------
Approved by Date Page: 40 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 09:01:50 Event: - The condenser is cooled to -40°C.
6/4/2021 09:02:00 -44.7 -45.0 -41.7 14.8 - 200 230 170 21
6/4/2021 09:03:00 -44.6 -45.0 -46.5 14.3 - 200 230 170 11
6/4/2021 09:04:00 -44.5 -45.0 -48.3 13.8 - 200 230 170 8
6/4/2021 09:05:00 -44.5 -45.0 -49.3 13.3 - 200 230 170 6
6/4/2021 09:06:00 -44.4 -45.0 -50.7 12.6 - 200 230 170 6
6/4/2021 09:07:00 -44.4 -45.0 -52.7 12.0 - 200 230 170 5
6/4/2021 09:08:00 -44.3 -45.0 -54.5 11.4 - 200 230 170 4
6/4/2021 09:09:00 -44.3 -45.0 -56.1 10.8 - 200 230 170 4
6/4/2021 09:10:00 -44.3 -45.0 -57.1 10.1 - 200 230 170 4
6/4/2021 09:11:00 -44.3 -45.0 -57.8 9.5 - 200 230 170 4
6/4/2021 09:12:00 -44.3 -45.0 -58.0 8.8 - 200 230 170 5
6/4/2021 09:12:45 Event: - The evacuation is started.
6/4/2021 09:13:00 -44.3 -45.0 -57.8 8.3 - 200 230 170 -
6/4/2021 09:14:00 -44.3 -45.0 -59.0 7.4 - 200 230 170 -
6/4/2021 09:15:00 -44.4 -45.0 -60.2 6.5 - 200 230 170 -
6/4/2021 09:16:00 -44.4 -45.0 -61.4 5.8 - 200 230 170 -
6/4/2021 09:17:00 -44.4 -45.0 -62.5 5.2 - 200 230 170 -
6/4/2021 09:18:00 -44.5 -45.0 -63.4 4.7 - 200 230 170 -
6/4/2021 09:19:00 -44.5 -45.0 -64.2 4.2 - 200 230 170 -
6/4/2021 09:20:00 -44.6 -45.0 -65.1 3.9 - 200 230 170 -
6/4/2021 09:20:02 Alarm: CLOSE - Communication fail with SQL database.
6/4/2021 09:21:00 -44.6 -45.0 -66.0 3.5 - 200 230 170 -
6/4/2021 09:22:00 -44.7 -45.0 -66.8 3.3 - 200 230 170 -
6/4/2021 09:23:00 -44.8 -45.0 -67.7 3.1 - 200 230 170 -
6/4/2021 09:24:00 -44.8 -45.0 -68.6 3.0 - 200 230 170 -
6/4/2021 09:25:00 -44.9 -45.0 -69.5 2.7 - 200 230 170 -

-------------------------------------------
Approved by Date Page: 41 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 09:26:00 -44.9 -45.0 -70.4 2.6 - 200 230 170 -
6/4/2021 09:27:00 -44.9 -45.0 -71.0 2.4 - 200 230 170 -
6/4/2021 09:28:00 -44.9 -45.0 -71.6 2.1 733 200 230 170 853
6/4/2021 09:29:00 -44.9 -45.0 -72.0 1.8 380 200 230 170 410
6/4/2021 09:30:00 -44.9 -45.0 -72.4 1.6 217 200 230 170 209
6/4/2021 09:30:10 Event: - Step advanced to [6] Drying
6/4/2021 09:31:00 -44.9 -44.5 -72.7 1.3 197 200 230 170 184
6/4/2021 09:32:00 -45.0 -44.0 -72.9 1.1 200 200 230 170 188
6/4/2021 09:33:00 -45.0 -43.5 -73.2 0.8 200 200 230 170 188
6/4/2021 09:34:00 -45.0 -43.0 -73.5 0.4 200 200 230 170 187
6/4/2021 09:35:00 -44.5 -42.5 -73.7 -1.8 200 200 230 170 187
6/4/2021 09:36:00 -43.4 -42.0 -74.0 -28.9 200 200 230 170 187
6/4/2021 09:37:00 -42.3 -41.5 -74.4 -42.5 200 200 230 170 186
6/4/2021 09:38:00 -41.3 -41.0 -74.6 -48.8 200 200 230 170 185
6/4/2021 09:39:00 -40.5 -40.5 -75.1 -54.0 201 200 230 170 185
6/4/2021 09:40:00 -39.7 -40.0 -75.3 -58.3 200 200 230 170 185
6/4/2021 09:41:00 -39.1 -39.5 -75.4 -61.6 200 200 230 170 185
6/4/2021 09:42:00 -38.7 -39.0 -75.7 -64.0 200 200 230 170 185
6/4/2021 09:43:00 -38.5 -38.5 -76.0 -65.9 200 200 230 170 185
6/4/2021 09:44:00 -38.2 -38.0 -76.5 -67.5 199 200 230 170 185
6/4/2021 09:45:00 -37.8 -37.5 -77.0 -68.9 201 200 230 170 184
6/4/2021 09:46:00 -37.2 -37.0 -77.1 -70.1 201 200 230 170 185
6/4/2021 09:47:00 -36.6 -36.5 -76.1 -71.2 199 200 230 170 184
6/4/2021 09:48:00 -36.0 -36.0 -74.4 -72.2 199 200 230 170 184
6/4/2021 09:49:00 -35.4 -35.5 -73.7 -73.0 200 200 230 170 184
6/4/2021 09:50:00 -34.9 -35.0 -75.1 -73.7 200 200 230 170 183
6/4/2021 09:51:00 -34.5 -34.5 -76.1 -74.3 200 200 230 170 182

-------------------------------------------
Approved by Date Page: 42 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 09:52:00 -34.1 -34.0 -75.6 -74.9 201 200 230 170 182
6/4/2021 09:53:00 -33.7 -33.5 -73.8 -75.4 200 200 230 170 181
6/4/2021 09:54:00 -33.1 -33.0 -72.0 -75.7 199 200 230 170 181
6/4/2021 09:55:00 -32.6 -32.5 -70.4 -75.9 200 200 230 170 181
6/4/2021 09:56:00 -32.0 -32.0 -71.8 -76.1 199 200 230 170 181
6/4/2021 09:57:00 -31.5 -31.5 -72.9 -76.2 201 200 230 170 181
6/4/2021 09:58:00 -31.0 -31.0 -73.4 -76.4 199 200 230 170 181
6/4/2021 09:59:00 -30.5 -30.5 -72.1 -76.6 200 200 230 170 181
6/4/2021 10:00:00 -30.0 -30.0 -70.5 -76.6 200 200 230 170 181
6/4/2021 10:01:00 -29.5 -29.5 -68.8 -76.4 200 200 230 170 180
6/4/2021 10:02:00 -29.0 -29.0 -69.6 -76.2 200 200 230 170 181
6/4/2021 10:03:00 -28.5 -28.5 -70.2 -76.3 200 200 230 170 180
6/4/2021 10:04:00 -28.0 -28.0 -70.8 -76.5 199 200 230 170 179
6/4/2021 10:05:00 -27.5 -27.5 -70.4 -76.7 201 200 230 170 181
6/4/2021 10:06:00 -27.0 -27.0 -68.8 -76.9 204 200 230 170 182
6/4/2021 10:07:00 -26.5 -26.5 -68.8 -76.9 202 200 230 170 182
6/4/2021 10:08:00 -26.0 -26.0 -69.6 -76.7 201 200 230 170 181
6/4/2021 10:09:00 -25.5 -25.5 -70.2 -76.3 199 200 230 170 179
6/4/2021 10:10:00 -24.9 -25.0 -70.6 -76.3 199 200 230 170 177
6/4/2021 10:11:00 -24.5 -24.5 -70.9 -76.2 197 200 230 170 175
6/4/2021 10:12:00 -24.0 -24.0 -71.2 -76.2 197 200 230 170 172
6/4/2021 10:13:00 -23.6 -23.5 -71.5 -75.9 197 200 230 170 172
6/4/2021 10:14:00 -23.1 -23.0 -71.5 -75.4 199 200 230 170 172
6/4/2021 10:15:00 -22.6 -22.5 -71.6 -74.9 199 200 230 170 172
6/4/2021 10:16:00 -22.0 -22.0 -71.4 -74.4 199 200 230 170 172
6/4/2021 10:17:00 -21.4 -21.5 -71.2 -73.9 199 200 230 170 172
6/4/2021 10:18:00 -20.9 -21.0 -71.0 -73.4 197 200 230 170 171

-------------------------------------------
Approved by Date Page: 43 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 10:19:00 -20.5 -20.5 -70.6 -72.8 197 200 230 170 169
6/4/2021 10:20:00 -20.0 -20.0 -70.4 -72.2 196 200 230 170 167
6/4/2021 10:21:00 -19.5 -19.6 -69.9 -71.4 194 200 230 170 166
6/4/2021 10:22:00 -19.1 -19.1 -69.6 -70.8 194 200 230 170 170
6/4/2021 10:23:00 -18.6 -18.6 -69.2 -71.1 196 200 230 170 173
6/4/2021 10:24:00 -18.1 -18.1 -68.8 -71.4 199 200 230 170 176
6/4/2021 10:25:00 -17.7 -17.6 -68.5 -70.8 201 200 230 170 179
6/4/2021 10:26:00 -17.1 -17.1 -68.4 -69.9 204 200 230 170 181
6/4/2021 10:27:00 -16.6 -16.6 -68.2 -68.9 205 200 230 170 182
6/4/2021 10:28:00 -16.1 -16.1 -68.2 -67.8 202 200 230 170 178
6/4/2021 10:29:00 -15.5 -15.6 -68.1 -67.4 199 200 230 170 172
6/4/2021 10:30:00 -15.0 -15.1 -68.2 -68.1 197 200 230 170 171
6/4/2021 10:31:00 -14.6 -14.6 -68.3 -68.7 199 200 230 170 174
6/4/2021 10:32:00 -14.1 -14.1 -68.5 -68.3 199 200 230 170 176
6/4/2021 10:33:00 -13.6 -13.6 -68.7 -67.5 201 200 230 170 177
6/4/2021 10:34:00 -13.1 -13.1 -69.0 -66.7 202 200 230 170 177
6/4/2021 10:35:00 -12.5 -12.6 -69.3 -65.9 199 200 230 170 176
6/4/2021 10:36:00 -12.1 -12.1 -69.6 -65.3 200 200 230 170 176
6/4/2021 10:37:00 -11.6 -11.6 -69.7 -64.7 199 200 230 170 177
6/4/2021 10:38:00 -11.2 -11.1 -69.9 -64.2 199 200 230 170 177
6/4/2021 10:39:00 -10.7 -10.6 -70.0 -63.5 200 200 230 170 177
6/4/2021 10:40:00 -10.0 -10.1 -70.1 -62.7 199 200 230 170 177
6/4/2021 10:41:00 -9.6 -9.6 -70.1 -61.9 201 200 230 170 178
6/4/2021 10:42:00 -9.1 -9.1 -70.2 -61.1 200 200 230 170 178
6/4/2021 10:43:00 -8.6 -8.6 -70.3 -60.6 201 200 230 170 178
6/4/2021 10:44:00 -8.0 -8.1 -70.2 -59.9 200 200 230 170 179
6/4/2021 10:45:00 -7.6 -7.6 -70.0 -59.1 200 200 230 170 179

-------------------------------------------
Approved by Date Page: 44 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 10:46:00 -7.1 -7.1 -69.7 -58.3 201 200 230 170 180
6/4/2021 10:47:00 -6.6 -6.6 -69.4 -57.5 200 200 230 170 181
6/4/2021 10:48:00 -6.1 -6.1 -69.3 -58.3 200 200 230 170 182
6/4/2021 10:48:52 Audit: - A_SQLCOMMFAIL ALARM is acknowledged by IDIN.
6/4/2021 10:49:00 -5.6 -5.6 -69.3 -60.1 201 200 230 170 182
6/4/2021 10:50:00 -5.2 -5.1 -69.2 -59.9 200 200 230 170 182
6/4/2021 10:51:00 -4.7 -4.6 -69.0 -58.9 201 200 230 170 182
6/4/2021 10:52:00 -4.2 -4.1 -68.6 -57.6 201 200 230 170 184
6/4/2021 10:53:00 -3.7 -3.6 -68.3 -56.5 201 200 230 170 186
6/4/2021 10:54:00 -3.2 -3.1 -68.1 -57.6 200 200 230 170 186
6/4/2021 10:55:00 -2.7 -2.6 -68.0 -59.1 200 200 230 170 186
6/4/2021 10:56:00 -2.2 -2.1 -68.1 -59.1 201 200 230 170 186
6/4/2021 10:57:00 -1.7 -1.6 -67.7 -57.6 201 200 230 170 186
6/4/2021 10:58:00 -1.2 -1.1 -67.2 -56.0 201 200 230 170 186
6/4/2021 10:59:00 -0.7 -0.6 -66.4 -54.4 199 200 230 170 187
6/4/2021 11:00:00 -0.1 -0.1 -66.1 -55.5 199 200 230 170 186
6/4/2021 11:01:00 0.4 0.4 -66.6 -57.6 200 200 230 170 187
6/4/2021 11:02:00 0.9 0.9 -67.2 -58.7 200 200 230 170 184
6/4/2021 11:03:00 1.4 1.4 -67.0 -58.2 201 200 230 170 184
6/4/2021 11:04:00 1.9 1.9 -65.8 -56.4 201 200 230 170 184
6/4/2021 11:05:00 2.3 2.4 -64.9 -54.6 201 200 230 170 184
6/4/2021 11:06:00 2.9 2.9 -64.6 -55.9 200 200 230 170 183
6/4/2021 11:07:00 3.4 3.4 -65.2 -57.3 200 200 230 170 181
6/4/2021 11:08:00 3.9 3.9 -67.2 -58.2 199 200 230 170 180
6/4/2021 11:09:00 4.4 4.4 -67.2 -58.2 199 200 230 170 180
6/4/2021 11:10:00 4.9 4.9 -65.6 -56.3 201 200 230 170 180
6/4/2021 11:10:10 Event: - Step advanced to [7] Drying

-------------------------------------------
Approved by Date Page: 45 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 11:11:00 5.4 5.0 -64.4 -54.1 199 200 230 170 180
6/4/2021 11:12:00 5.7 5.0 -64.1 -55.3 201 200 230 170 181
6/4/2021 11:13:00 5.7 5.0 -65.0 -56.8 199 200 230 170 177
6/4/2021 11:14:00 5.5 5.0 -67.2 -58.4 201 200 230 170 177
6/4/2021 11:15:00 5.2 5.0 -67.3 -58.8 201 200 230 170 177
6/4/2021 11:16:00 4.9 5.0 -65.7 -57.3 201 200 230 170 178
6/4/2021 11:17:00 4.7 5.0 -64.2 -54.5 201 200 230 170 179
6/4/2021 11:18:00 4.6 5.0 -63.8 -52.4 200 200 230 170 180
6/4/2021 11:19:00 4.8 5.0 -64.1 -54.5 201 200 230 170 180
6/4/2021 11:20:00 4.9 5.0 -66.0 -56.8 201 200 230 170 179
6/4/2021 11:21:00 5.1 5.0 -66.6 -58.9 199 200 230 170 177
6/4/2021 11:22:00 5.2 5.0 -66.4 -60.7 199 200 230 170 176
6/4/2021 11:23:00 5.2 5.0 -66.1 -61.1 199 200 230 170 177
6/4/2021 11:24:00 5.1 5.0 -65.8 -59.2 200 200 230 170 179
6/4/2021 11:25:00 5.0 5.0 -65.6 -56.4 200 200 230 170 180
6/4/2021 11:26:00 5.0 5.0 -65.5 -56.4 201 200 230 170 180
6/4/2021 11:27:00 4.9 5.0 -66.1 -57.4 199 200 230 170 177
6/4/2021 11:28:00 4.9 5.0 -66.3 -59.3 199 200 230 170 176
6/4/2021 11:29:00 4.9 5.0 -66.4 -61.3 201 200 230 170 178
6/4/2021 11:30:00 5.0 5.0 -66.7 -61.6 200 200 230 170 178
6/4/2021 11:31:00 5.0 5.0 -66.5 -59.6 200 200 230 170 180
6/4/2021 11:32:00 5.1 5.0 -66.1 -57.3 199 200 230 170 179
6/4/2021 11:33:00 5.1 5.0 -65.3 -57.1 199 200 230 170 178
6/4/2021 11:34:00 5.1 5.0 -65.0 -57.7 201 200 230 170 178
6/4/2021 11:35:00 5.0 5.0 -65.6 -58.9 201 200 230 170 177
6/4/2021 11:36:00 5.0 5.0 -66.7 -60.8 199 200 230 170 176
6/4/2021 11:37:00 4.9 5.0 -67.7 -61.6 199 200 230 170 177

-------------------------------------------
Approved by Date Page: 46 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 11:38:00 4.9 5.0 -67.8 -61.2 200 200 230 170 177
6/4/2021 11:39:00 4.9 5.0 -66.3 -58.7 201 200 230 170 179
6/4/2021 11:40:00 5.0 5.0 -64.2 -55.3 201 200 230 170 180
6/4/2021 11:41:00 5.1 5.0 -63.1 -54.5 199 200 230 170 180
6/4/2021 11:42:00 5.1 5.0 -63.9 -55.7 199 200 230 170 178
6/4/2021 11:43:00 5.1 5.0 -66.2 -57.6 200 200 230 170 178
6/4/2021 11:44:00 5.0 5.0 -67.5 -60.1 201 200 230 170 177
6/4/2021 11:45:00 5.0 5.0 -67.1 -61.4 200 200 230 170 176
6/4/2021 11:46:00 4.9 5.0 -65.4 -60.5 201 200 230 170 178
6/4/2021 11:47:00 4.9 5.0 -64.2 -57.9 201 200 230 170 180
6/4/2021 11:48:00 5.0 5.0 -64.3 -57.1 201 200 230 170 180
6/4/2021 11:49:00 5.0 5.0 -65.5 -57.5 199 200 230 170 178
6/4/2021 11:50:00 5.1 5.0 -67.1 -59.0 199 200 230 170 176
6/4/2021 11:51:00 5.1 5.0 -67.2 -61.0 201 200 230 170 176
6/4/2021 11:52:00 5.1 5.0 -66.3 -61.7 199 200 230 170 176
6/4/2021 11:53:00 5.0 5.0 -65.6 -61.0 199 200 230 170 177
6/4/2021 11:54:00 5.0 5.0 -65.2 -58.6 200 200 230 170 179
6/4/2021 11:55:00 5.0 5.0 -65.0 -56.0 201 200 230 170 180
6/4/2021 11:56:00 4.9 5.0 -65.2 -56.4 199 200 230 170 178
6/4/2021 11:57:00 4.9 5.0 -65.6 -57.2 199 200 230 170 176
6/4/2021 11:58:00 4.9 5.0 -65.7 -58.8 201 200 230 170 177
6/4/2021 11:59:00 5.0 5.0 -66.0 -60.8 199 200 230 170 176
6/4/2021 12:00:00 5.0 5.0 -66.6 -61.5 201 200 230 170 178
6/4/2021 12:01:00 5.1 5.0 -66.6 -59.9 200 200 230 170 179
6/4/2021 12:02:00 5.1 5.0 -65.8 -57.1 200 200 230 170 179
6/4/2021 12:03:00 5.1 5.0 -64.7 -56.7 199 200 230 170 177
6/4/2021 12:04:00 5.0 5.0 -64.5 -57.3 201 200 230 170 178

-------------------------------------------
Approved by Date Page: 47 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 12:05:00 5.0 5.0 -65.6 -58.9 201 200 230 170 178
6/4/2021 12:06:00 5.0 5.0 -67.0 -60.9 199 200 230 170 178
6/4/2021 12:07:00 4.9 5.0 -68.0 -61.8 200 200 230 170 177
6/4/2021 12:08:00 4.9 5.0 -67.4 -61.0 201 200 230 170 178
6/4/2021 12:09:00 5.0 5.0 -65.4 -58.3 201 200 230 170 179
6/4/2021 12:10:00 5.0 5.0 -63.8 -56.2 201 200 230 170 179
6/4/2021 12:11:00 5.0 5.0 -63.6 -56.8 199 200 230 170 179
6/4/2021 12:12:00 5.1 5.0 -65.6 -58.0 201 200 230 170 180
6/4/2021 12:13:00 5.1 5.0 -67.5 -60.0 200 200 230 170 179
6/4/2021 12:14:00 5.0 5.0 -67.8 -61.1 199 200 230 170 177
6/4/2021 12:15:00 5.0 5.0 -66.8 -61.5 201 200 230 170 177
6/4/2021 12:16:00 5.0 5.0 -64.9 -59.6 201 200 230 170 178
6/4/2021 12:17:00 5.0 5.0 -63.9 -56.7 201 200 230 170 179
6/4/2021 12:18:00 4.9 5.0 -63.8 -55.0 199 200 230 170 180
6/4/2021 12:19:00 4.9 5.0 -64.6 -56.0 200 200 230 170 180
6/4/2021 12:20:00 5.0 5.0 -66.0 -57.4 200 200 230 170 178
6/4/2021 12:21:00 5.0 5.0 -66.4 -59.1 199 200 230 170 176
6/4/2021 12:22:00 5.0 5.0 -65.8 -61.2 201 200 230 170 177
6/4/2021 12:23:00 5.0 5.0 -65.6 -61.7 201 200 230 170 178
6/4/2021 12:24:00 5.0 5.0 -65.5 -60.2 199 200 230 170 180
6/4/2021 12:25:00 5.0 5.0 -65.5 -58.1 199 200 230 170 181
6/4/2021 12:26:00 5.0 5.0 -65.6 -57.8 200 200 230 170 180
6/4/2021 12:27:00 5.0 5.0 -65.9 -58.3 199 200 230 170 177
6/4/2021 12:28:00 5.0 5.0 -65.8 -59.6 199 200 230 170 176
6/4/2021 12:29:00 5.0 5.0 -65.8 -61.2 201 200 230 170 178
6/4/2021 12:30:00 5.0 5.0 -66.2 -61.7 200 200 230 170 180
6/4/2021 12:31:00 5.0 5.0 -66.6 -60.9 199 200 230 170 179

-------------------------------------------
Approved by Date Page: 48 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 12:32:00 5.0 5.0 -66.2 -58.5 201 200 230 170 179
6/4/2021 12:33:00 5.0 5.0 -64.8 -55.3 201 200 230 170 180
6/4/2021 12:34:00 5.0 5.0 -63.1 -54.3 199 200 230 170 179
6/4/2021 12:35:00 5.0 5.0 -63.0 -55.8 201 200 230 170 181
6/4/2021 12:36:00 5.0 5.0 -65.2 -57.8 199 200 230 170 180
6/4/2021 12:37:00 5.1 5.0 -67.0 -59.7 200 200 230 170 180
6/4/2021 12:38:00 5.0 5.0 -67.7 -60.9 199 200 230 170 178
6/4/2021 12:39:00 5.1 5.0 -66.4 -59.8 199 200 230 170 177
6/4/2021 12:40:00 5.1 5.0 -64.3 -57.4 201 200 230 170 179
6/4/2021 12:41:00 5.0 5.0 -63.0 -56.3 201 200 230 170 180
6/4/2021 12:42:00 5.0 5.0 -63.5 -57.0 201 200 230 170 181
6/4/2021 12:43:00 5.0 5.0 -65.6 -58.1 199 200 230 170 179
6/4/2021 12:44:00 5.0 5.0 -67.1 -59.5 200 200 230 170 179
6/4/2021 12:45:00 5.0 5.0 -67.0 -61.0 199 200 230 170 176
6/4/2021 12:46:00 5.0 5.0 -66.1 -61.5 200 200 230 170 177
6/4/2021 12:47:00 5.0 5.0 -65.0 -60.4 201 200 230 170 179
6/4/2021 12:48:00 5.0 5.0 -64.3 -57.7 199 200 230 170 180
6/4/2021 12:49:00 5.0 5.0 -64.5 -55.2 199 200 230 170 182
6/4/2021 12:50:00 5.0 5.0 -64.9 -56.1 200 200 230 170 181
6/4/2021 12:51:00 5.0 5.0 -65.8 -57.2 201 200 230 170 179
6/4/2021 12:52:00 5.0 5.0 -66.0 -59.0 199 200 230 170 177
6/4/2021 12:53:00 5.0 5.0 -65.6 -60.9 200 200 230 170 177
6/4/2021 12:54:00 5.0 5.0 -65.3 -60.9 201 200 230 170 180
6/4/2021 12:55:00 5.0 5.0 -65.3 -58.9 199 200 230 170 181
6/4/2021 12:56:00 5.0 5.0 -65.5 -58.0 199 200 230 170 182
6/4/2021 12:57:00 5.0 5.0 -66.0 -58.2 201 200 230 170 181
6/4/2021 12:58:00 5.0 5.0 -66.4 -58.9 199 200 230 170 177

-------------------------------------------
Approved by Date Page: 49 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 12:59:00 5.0 5.0 -66.1 -60.5 201 200 230 170 178
6/4/2021 13:00:00 5.0 5.0 -65.8 -61.6 201 200 230 170 179
6/4/2021 13:01:00 5.0 5.0 -65.8 -61.4 199 200 230 170 179
6/4/2021 13:02:00 5.0 5.0 -65.9 -59.4 200 200 230 170 182
6/4/2021 13:03:00 5.0 5.0 -65.8 -58.1 201 200 230 170 182
6/4/2021 13:04:00 5.0 5.0 -65.5 -58.4 199 200 230 170 179
6/4/2021 13:05:00 5.0 5.0 -65.6 -59.0 201 200 230 170 178
6/4/2021 13:06:00 5.0 5.0 -65.6 -60.6 199 200 230 170 178
6/4/2021 13:07:00 5.0 5.0 -66.2 -61.6 201 200 230 170 180
6/4/2021 13:08:00 5.0 5.0 -67.1 -61.8 200 200 230 170 182
6/4/2021 13:09:00 5.0 5.0 -67.3 -60.7 200 200 230 170 181
6/4/2021 13:10:00 5.0 5.0 -66.3 -58.1 199 200 230 170 180
6/4/2021 13:11:00 5.0 5.0 -64.2 -55.3 199 200 230 170 180
6/4/2021 13:12:00 5.0 5.0 -62.7 -55.5 201 200 230 170 181
6/4/2021 13:13:00 5.0 5.0 -63.2 -56.6 201 200 230 170 181
6/4/2021 13:14:00 5.0 5.0 -65.7 -58.1 199 200 230 170 181
6/4/2021 13:15:00 5.0 5.0 -67.3 -59.9 199 200 230 170 179
6/4/2021 13:16:00 5.0 5.0 -67.7 -61.0 201 200 230 170 179
6/4/2021 13:17:00 5.0 5.0 -66.4 -60.3 199 200 230 170 178
6/4/2021 13:18:00 5.0 5.0 -64.5 -58.5 199 200 230 170 179
6/4/2021 13:19:00 5.0 5.0 -63.7 -57.9 201 200 230 170 181
6/4/2021 13:20:00 5.0 5.0 -64.5 -58.3 201 200 230 170 182
6/4/2021 13:21:00 5.0 5.0 -66.6 -59.1 201 200 230 170 181
6/4/2021 13:22:00 5.0 5.0 -67.7 -60.7 199 200 230 170 178
6/4/2021 13:23:00 5.0 5.0 -67.3 -61.7 199 200 230 170 178
6/4/2021 13:24:00 5.0 5.0 -66.1 -61.7 201 200 230 170 179
6/4/2021 13:25:00 5.0 5.0 -65.0 -60.0 199 200 230 170 179

-------------------------------------------
Approved by Date Page: 50 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 13:26:00 5.0 5.0 -64.5 -57.8 200 200 230 170 182
6/4/2021 13:27:00 5.0 5.0 -65.0 -58.1 201 200 230 170 183
6/4/2021 13:28:00 5.0 5.0 -66.3 -58.4 199 200 230 170 180
6/4/2021 13:29:00 5.0 5.0 -66.9 -59.6 199 200 230 170 179
6/4/2021 13:30:00 5.0 5.0 -66.5 -61.1 201 200 230 170 179
6/4/2021 13:31:00 5.0 5.0 -66.0 -61.7 200 200 230 170 179
6/4/2021 13:32:00 5.0 5.0 -65.6 -60.4 199 200 230 170 181
6/4/2021 13:33:00 5.0 5.0 -65.6 -58.1 199 200 230 170 183
6/4/2021 13:34:00 5.0 5.0 -65.6 -57.8 199 200 230 170 182
6/4/2021 13:35:00 5.0 5.0 -65.9 -58.0 201 200 230 170 181
6/4/2021 13:36:00 5.0 5.0 -66.0 -59.0 201 200 230 170 179
6/4/2021 13:37:00 5.0 5.0 -65.8 -61.0 199 200 230 170 178
6/4/2021 13:38:00 5.0 5.0 -66.0 -61.9 200 200 230 170 181
6/4/2021 13:39:00 5.0 5.0 -66.3 -61.1 200 200 230 170 183
6/4/2021 13:40:00 5.0 5.0 -66.5 -59.3 201 200 230 170 184
6/4/2021 13:41:00 5.0 5.0 -66.4 -59.0 199 200 230 170 182
6/4/2021 13:42:00 5.0 5.0 -66.1 -59.0 201 200 230 170 181
6/4/2021 13:43:00 5.0 5.0 -65.8 -59.7 201 200 230 170 179
6/4/2021 13:44:00 4.9 5.0 -65.7 -61.3 201 200 230 170 180
6/4/2021 13:45:00 5.0 5.0 -66.1 -62.0 199 200 230 170 180
6/4/2021 13:46:00 5.0 5.0 -66.6 -61.4 200 200 230 170 182
6/4/2021 13:47:00 5.0 5.0 -66.7 -59.3 201 200 230 170 183
6/4/2021 13:48:00 5.0 5.0 -65.9 -58.4 201 200 230 170 182
6/4/2021 13:49:00 5.0 5.0 -64.9 -58.5 200 200 230 170 181
6/4/2021 13:50:00 5.0 5.0 -65.0 -59.0 199 200 230 170 180
6/4/2021 13:51:00 5.0 5.0 -65.5 -60.5 200 200 230 170 181
6/4/2021 13:52:00 5.0 5.0 -66.6 -61.6 199 200 230 170 182

-------------------------------------------
Approved by Date Page: 51 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 13:53:00 5.0 5.0 -67.5 -61.8 199 200 230 170 182
6/4/2021 13:54:00 5.0 5.0 -67.2 -60.3 201 200 230 170 181
6/4/2021 13:55:00 5.0 5.0 -65.6 -57.8 200 200 230 170 182
6/4/2021 13:56:00 5.0 5.0 -63.7 -57.6 200 200 230 170 182
6/4/2021 13:57:00 5.0 5.0 -63.8 -57.9 199 200 230 170 181
6/4/2021 13:58:00 5.0 5.0 -65.4 -59.0 199 200 230 170 181
6/4/2021 13:59:00 5.0 5.0 -67.1 -60.7 199 200 230 170 182
6/4/2021 14:00:00 5.0 5.0 -67.8 -61.2 201 200 230 170 181
6/4/2021 14:01:00 5.0 5.0 -66.8 -60.1 199 200 230 170 180
6/4/2021 14:02:00 5.0 5.0 -64.9 -58.4 199 200 230 170 180
6/4/2021 14:03:00 5.0 5.0 -63.7 -58.4 201 200 230 170 182
6/4/2021 14:04:00 5.0 5.0 -64.2 -58.6 201 200 230 170 183
6/4/2021 14:05:00 5.0 5.0 -66.1 -59.0 201 200 230 170 183
6/4/2021 14:06:00 5.0 5.0 -67.6 -60.2 201 200 230 170 182
6/4/2021 14:07:00 5.0 5.0 -67.7 -61.6 200 200 230 170 181
6/4/2021 14:08:00 5.0 5.0 -66.8 -61.7 199 200 230 170 180
6/4/2021 14:09:00 5.0 5.0 -65.3 -60.2 199 200 230 170 179
6/4/2021 14:10:00 5.0 5.0 -64.5 -58.2 199 200 230 170 181
6/4/2021 14:11:00 5.0 5.0 -64.7 -58.2 199 200 230 170 183
6/4/2021 14:12:00 5.0 5.0 -65.9 -58.5 201 200 230 170 183
6/4/2021 14:13:00 5.0 5.0 -67.2 -59.1 200 200 230 170 182
6/4/2021 14:14:00 5.0 5.0 -67.3 -60.9 201 200 230 170 181
6/4/2021 14:15:00 5.0 5.0 -66.5 -62.0 201 200 230 170 180
6/4/2021 14:16:00 5.0 5.0 -65.5 -61.4 201 200 230 170 180
6/4/2021 14:17:00 5.0 5.0 -64.9 -59.5 201 200 230 170 182
6/4/2021 14:18:00 5.0 5.0 -65.1 -59.2 201 200 230 170 184
6/4/2021 14:18:01 Alarm: CLOSE - Communication fail with SQL database.

-------------------------------------------
Approved by Date Page: 52 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 14:18:11 Audit: - A_SQLCOMMFAIL ALARM is acknowledged by IDIN.
6/4/2021 14:18:15 Audit: - Alarm is reset manually by IDIN.
6/4/2021 14:19:00 5.0 5.0 -66.3 -59.0 199 200 230 170 183
6/4/2021 14:20:00 5.0 5.0 -67.4 -59.7 199 200 230 170 181
6/4/2021 14:21:00 5.0 5.0 -67.4 -61.5 200 200 230 170 180
6/4/2021 14:22:00 5.0 5.0 -66.4 -61.9 201 200 230 170 181
6/4/2021 14:23:00 5.0 5.0 -65.5 -60.7 201 200 230 170 182
6/4/2021 14:24:00 5.0 5.0 -65.0 -59.7 200 200 230 170 184
6/4/2021 14:25:00 5.0 5.0 -65.5 -59.5 199 200 230 170 184
6/4/2021 14:26:00 5.0 5.0 -66.8 -59.5 200 200 230 170 183
6/4/2021 14:27:00 5.0 5.0 -67.3 -60.3 201 200 230 170 181
6/4/2021 14:28:00 5.0 5.0 -66.8 -61.8 199 200 230 170 180
6/4/2021 14:29:00 5.0 5.0 -66.1 -61.9 200 200 230 170 180
6/4/2021 14:30:00 5.0 5.0 -65.6 -60.6 201 200 230 170 183
6/4/2021 14:31:00 5.0 5.0 -65.6 -58.9 201 200 230 170 186
6/4/2021 14:32:00 5.0 5.0 -65.9 -59.0 200 200 230 170 186
6/4/2021 14:33:00 5.0 5.0 -66.6 -59.1 199 200 230 170 182
6/4/2021 14:34:00 5.0 5.0 -66.7 -59.8 199 200 230 170 180
6/4/2021 14:35:00 5.0 5.0 -66.3 -61.2 201 200 230 170 181
6/4/2021 14:36:00 5.0 5.0 -66.1 -62.1 201 200 230 170 182
6/4/2021 14:37:00 5.0 5.0 -66.3 -61.8 201 200 230 170 183
6/4/2021 14:38:00 5.0 5.0 -66.4 -60.2 201 200 230 170 186
6/4/2021 14:39:00 5.0 5.0 -66.3 -58.1 201 200 230 170 186
6/4/2021 14:40:00 5.0 5.0 -65.5 -58.3 199 200 230 170 183
6/4/2021 14:41:00 5.0 5.0 -65.0 -58.4 199 200 230 170 181
6/4/2021 14:42:00 5.0 5.0 -65.3 -59.6 199 200 230 170 181
6/4/2021 14:43:00 5.0 5.0 -65.9 -61.6 199 200 230 170 181

-------------------------------------------
Approved by Date Page: 53 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 14:44:00 5.0 5.0 -66.8 -61.8 199 200 230 170 183
6/4/2021 14:45:00 5.0 5.0 -67.2 -60.4 199 200 230 170 184
6/4/2021 14:46:00 5.0 5.0 -66.8 -59.7 199 200 230 170 184
6/4/2021 14:47:00 5.0 5.0 -65.8 -59.5 200 200 230 170 183
6/4/2021 14:48:00 5.0 5.0 -65.5 -59.6 200 200 230 170 182
6/4/2021 14:49:00 5.0 5.0 -65.7 -60.5 199 200 230 170 182
6/4/2021 14:50:00 5.0 5.0 -66.5 -61.8 199 200 230 170 183
6/4/2021 14:51:00 5.0 5.0 -67.4 -61.4 199 200 230 170 184
6/4/2021 14:51:31 Alarm: CLOSE - Communication fail with SQL database.
6/4/2021 14:52:00 5.0 5.0 -67.7 -60.1 199 200 230 170 186
6/4/2021 14:53:00 5.0 5.0 -66.9 -59.7 201 200 230 170 186
6/4/2021 14:54:00 5.0 5.0 -65.7 -59.7 199 200 230 170 183
6/4/2021 14:55:00 5.0 5.0 -65.3 -59.6 199 200 230 170 182
6/4/2021 14:56:00 5.0 5.0 -65.6 -60.4 199 200 230 170 182
6/4/2021 14:57:00 5.0 5.0 -66.5 -61.8 199 200 230 170 183
6/4/2021 14:58:00 5.0 5.0 -67.6 -62.4 200 200 230 170 186
6/4/2021 14:59:00 5.0 5.0 -67.7 -61.5 200 200 230 170 184
6/4/2021 15:00:00 5.0 5.0 -66.6 -59.7 199 200 230 170 183
6/4/2021 15:01:00 5.0 5.0 -64.8 -58.8 200 200 230 170 183
6/4/2021 15:02:00 5.0 5.0 -64.1 -58.9 199 200 230 170 183
6/4/2021 15:03:00 5.0 5.0 -65.2 -59.0 199 200 230 170 184
6/4/2021 15:04:00 5.0 5.0 -66.8 -60.4 201 200 230 170 186
6/4/2021 15:05:00 5.0 5.0 -68.0 -62.1 201 200 230 170 184
6/4/2021 15:06:00 5.0 5.0 -67.8 -62.1 200 200 230 170 183
6/4/2021 15:07:00 5.0 5.0 -66.2 -60.7 200 200 230 170 182
6/4/2021 15:08:00 5.0 5.0 -64.7 -60.0 199 200 230 170 182
6/4/2021 15:09:00 5.0 5.0 -64.4 -59.7 200 200 230 170 183

-------------------------------------------
Approved by Date Page: 54 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 15:10:00 5.0 5.0 -65.9 -59.9 199 200 230 170 184
6/4/2021 15:11:00 5.0 5.0 -67.5 -61.0 199 200 230 170 184
6/4/2021 15:12:00 5.0 5.0 -68.5 -62.0 199 200 230 170 183
6/4/2021 15:13:00 5.0 5.0 -67.9 -61.5 199 200 230 170 182
6/4/2021 15:14:00 5.0 5.0 -66.1 -60.5 200 200 230 170 183
6/4/2021 15:15:00 5.0 5.0 -64.8 -60.3 200 200 230 170 183
6/4/2021 15:16:00 5.0 5.0 -64.8 -59.9 201 200 230 170 184
6/4/2021 15:17:00 5.0 5.0 -66.4 -60.0 201 200 230 170 186
6/4/2021 15:18:00 4.9 5.0 -67.7 -61.2 199 200 230 170 184
6/4/2021 15:19:00 4.9 5.0 -68.3 -62.2 200 200 230 170 183
6/4/2021 15:20:00 5.0 5.0 -67.4 -61.8 200 200 230 170 183
6/4/2021 15:21:00 5.0 5.0 -65.8 -60.4 200 200 230 170 183
6/4/2021 15:22:00 5.0 5.0 -64.8 -59.7 199 200 230 170 184
6/4/2021 15:23:00 5.1 5.0 -65.0 -59.7 200 200 230 170 186
6/4/2021 15:24:00 5.1 5.0 -66.7 -59.6 200 200 230 170 187
6/4/2021 15:25:00 5.0 5.0 -68.0 -60.6 200 200 230 170 186
6/4/2021 15:26:00 5.0 5.0 -68.2 -61.7 199 200 230 170 183
6/4/2021 15:27:00 5.0 5.0 -67.3 -62.2 199 200 230 170 182
6/4/2021 15:28:00 4.9 5.0 -65.8 -61.1 200 200 230 170 183
6/4/2021 15:29:00 4.9 5.0 -64.9 -59.2 201 200 230 170 186
6/4/2021 15:30:00 4.9 5.0 -64.8 -59.0 201 200 230 170 187
6/4/2021 15:31:00 5.0 5.0 -65.8 -58.9 199 200 230 170 187
6/4/2021 15:32:00 5.0 5.0 -67.1 -59.4 200 200 230 170 184
6/4/2021 15:33:00 5.0 5.0 -67.2 -61.2 201 200 230 170 183
6/4/2021 15:34:00 5.1 5.0 -66.5 -61.8 201 200 230 170 183
6/4/2021 15:35:00 5.1 5.0 -65.8 -61.0 201 200 230 170 184
6/4/2021 15:36:00 5.0 5.0 -65.5 -60.0 200 200 230 170 187

-------------------------------------------
Approved by Date Page: 55 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 15:37:00 5.0 5.0 -65.9 -59.9 199 200 230 170 186
6/4/2021 15:38:00 5.0 5.0 -67.0 -59.8 200 200 230 170 187
6/4/2021 15:39:00 5.0 5.0 -67.5 -60.1 201 200 230 170 184
6/4/2021 15:40:00 4.9 5.0 -67.0 -60.7 200 200 230 170 183
6/4/2021 15:41:00 4.9 5.0 -66.2 -60.5 200 200 230 170 183
6/4/2021 15:42:00 5.0 5.0 -65.6 -59.2 201 200 230 170 186
6/4/2021 15:43:00 5.0 5.0 -65.6 -59.4 200 200 230 170 187
6/4/2021 15:44:00 5.1 5.0 -66.1 -59.5 199 200 230 170 188
6/4/2021 15:45:00 5.1 5.0 -67.0 -59.6 201 200 230 170 185
6/4/2021 15:46:00 5.1 5.0 -67.2 -60.2 201 200 230 170 184
6/4/2021 15:47:00 5.0 5.0 -66.7 -61.0 200 200 230 170 183
6/4/2021 15:48:00 5.0 5.0 -66.2 -61.0 199 200 230 170 183
6/4/2021 15:49:00 5.0 5.0 -66.0 -59.8 200 200 230 170 186
6/4/2021 15:50:00 4.9 5.0 -66.3 -58.7 200 200 230 170 188
6/4/2021 15:51:00 4.9 5.0 -66.5 -59.1 199 200 230 170 188
6/4/2021 15:52:00 4.9 5.0 -66.9 -59.3 200 200 230 170 187
6/4/2021 15:53:00 5.0 5.0 -66.7 -59.7 200 200 230 170 184
6/4/2021 15:54:00 5.0 5.0 -66.3 -61.2 199 200 230 170 183
6/4/2021 15:55:00 5.1 5.0 -66.3 -62.1 200 200 230 170 186
6/4/2021 15:56:00 5.1 5.0 -66.6 -61.5 200 200 230 170 187
6/4/2021 15:57:00 5.0 5.0 -66.9 -59.9 199 200 230 170 188
6/4/2021 15:58:00 5.0 5.0 -66.7 -59.4 201 200 230 170 188
6/4/2021 15:58:02 Alarm: CLOSE - Communication fail with SQL database.
6/4/2021 15:58:27 Audit: - A_SQLCOMMFAIL ALARM is acknowledged by IDIN.
6/4/2021 15:59:00 5.0 5.0 -66.0 -59.3 200 200 230 170 186
6/4/2021 16:00:00 4.9 5.0 -65.8 -59.5 199 200 230 170 184
6/4/2021 16:01:00 4.9 5.0 -66.0 -60.5 201 200 230 170 184

-------------------------------------------
Approved by Date Page: 56 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 16:02:00 4.9 5.0 -66.4 -61.2 200 200 230 170 185
6/4/2021 16:03:00 5.0 5.0 -67.1 -60.5 201 200 230 170 188
6/4/2021 16:04:00 5.0 5.0 -67.3 -59.8 201 200 230 170 189
6/4/2021 16:05:00 5.1 5.0 -66.9 -59.8 199 200 230 170 187
6/4/2021 16:06:00 5.1 5.0 -66.4 -59.8 200 200 230 170 186
6/4/2021 16:07:00 5.1 5.0 -66.2 -60.1 200 200 230 170 184
6/4/2021 16:08:00 5.0 5.0 -66.4 -60.6 199 200 230 170 184
6/4/2021 16:09:00 5.0 5.0 -66.8 -60.3 200 200 230 170 186
6/4/2021 16:10:00 5.0 5.0 -67.3 -59.4 201 200 230 170 189
6/4/2021 16:11:00 5.0 5.0 -67.3 -59.6 199 200 230 170 188
6/4/2021 16:12:00 4.9 5.0 -66.8 -59.6 199 200 230 170 186
6/4/2021 16:13:00 5.0 5.0 -66.4 -59.9 200 200 230 170 186
6/4/2021 16:14:00 5.0 5.0 -66.3 -60.4 201 200 230 170 186
6/4/2021 16:15:00 5.0 5.0 -66.6 -60.9 200 200 230 170 187
6/4/2021 16:16:00 5.1 5.0 -67.1 -60.2 200 200 230 170 188
6/4/2021 16:17:00 5.1 5.0 -67.4 -59.4 200 200 230 170 188
6/4/2021 16:18:00 5.0 5.0 -67.1 -59.7 200 200 230 170 188
6/4/2021 16:19:00 5.0 5.0 -66.5 -59.7 199 200 230 170 185
6/4/2021 16:20:00 5.0 5.0 -66.2 -59.9 200 200 230 170 185
6/4/2021 16:21:00 5.0 5.0 -66.3 -61.2 199 200 230 170 184
6/4/2021 16:22:00 5.0 5.0 -66.8 -62.0 201 200 230 170 187
6/4/2021 16:23:00 5.0 5.0 -67.5 -61.6 200 200 230 170 188
6/4/2021 16:24:00 4.9 5.0 -67.8 -60.5 200 200 230 170 189
6/4/2021 16:25:00 4.9 5.0 -67.1 -59.9 200 200 230 170 188
6/4/2021 16:26:00 5.0 5.0 -65.9 -59.9 201 200 230 170 187
6/4/2021 16:27:00 5.0 5.0 -65.6 -59.8 199 200 230 170 186
6/4/2021 16:28:00 5.1 5.0 -66.0 -60.7 201 200 230 170 187

-------------------------------------------
Approved by Date Page: 57 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 16:29:00 5.1 5.0 -66.9 -62.0 199 200 230 170 187
6/4/2021 16:30:00 5.0 5.0 -68.0 -62.4 200 200 230 170 189
6/4/2021 16:31:00 5.0 5.0 -68.2 -61.5 200 200 230 170 188
6/4/2021 16:32:00 5.0 5.0 -67.2 -60.4 201 200 230 170 187
6/4/2021 16:33:00 5.0 5.0 -65.8 -60.3 199 200 230 170 187
6/4/2021 16:34:00 5.0 5.0 -65.5 -60.1 201 200 230 170 187
6/4/2021 16:35:00 4.9 5.0 -66.2 -60.5 200 200 230 170 188
6/4/2021 16:36:00 4.9 5.0 -67.5 -61.6 200 200 230 170 188
6/4/2021 16:37:00 4.9 5.0 -68.4 -61.7 199 200 230 170 189
6/4/2021 16:38:00 5.0 5.0 -68.4 -60.7 200 200 230 170 188
6/4/2021 16:39:00 5.0 5.0 -67.1 -60.5 199 200 230 170 187
6/4/2021 16:40:00 5.1 5.0 -65.8 -60.5 201 200 230 170 187
6/4/2021 16:41:00 5.1 5.0 -65.8 -60.4 201 200 230 170 187
6/4/2021 16:42:00 5.0 5.0 -66.6 -60.7 199 200 230 170 187
6/4/2021 16:43:00 5.0 5.0 -67.8 -61.2 199 200 230 170 188
6/4/2021 16:44:00 5.0 5.0 -68.4 -60.7 200 200 230 170 189
6/4/2021 16:45:00 5.0 5.0 -68.1 -60.2 200 200 230 170 189
6/4/2021 16:46:00 5.0 5.0 -66.9 -60.4 199 200 230 170 187
6/4/2021 16:47:00 4.9 5.0 -66.0 -60.3 200 200 230 170 188
6/4/2021 16:48:00 4.9 5.0 -66.1 -60.4 199 200 230 170 186
6/4/2021 16:49:00 5.0 5.0 -66.9 -60.9 200 200 230 170 188
6/4/2021 16:50:00 5.0 5.0 -67.8 -61.1 199 200 230 170 189
6/4/2021 16:51:00 5.0 5.0 -68.2 -60.2 199 200 230 170 189
6/4/2021 16:52:00 5.1 5.0 -67.6 -60.0 200 200 230 170 188
6/4/2021 16:53:00 5.0 5.0 -66.3 -60.3 200 200 230 170 187
6/4/2021 16:54:00 5.0 5.0 -65.8 -60.2 199 200 230 170 186
6/4/2021 16:55:00 5.0 5.0 -66.1 -60.4 199 200 230 170 186

-------------------------------------------
Approved by Date Page: 58 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 16:56:00 5.0 5.0 -67.0 -61.0 201 200 230 170 189
6/4/2021 16:57:00 5.0 5.0 -68.1 -61.3 200 200 230 170 189
6/4/2021 16:58:00 5.0 5.0 -68.5 -60.6 199 200 230 170 189
6/4/2021 16:59:00 5.0 5.0 -68.0 -59.5 200 200 230 170 189
6/4/2021 17:00:00 5.0 5.0 -66.5 -59.6 200 200 230 170 188
6/4/2021 17:01:00 5.0 5.0 -65.5 -59.9 199 200 230 170 187
6/4/2021 17:02:00 4.9 5.0 -65.8 -60.0 201 200 230 170 188
6/4/2021 17:03:00 5.0 5.0 -66.9 -61.0 201 200 230 170 189
6/4/2021 17:04:00 5.0 5.0 -68.2 -62.1 200 200 230 170 190
6/4/2021 17:05:00 5.0 5.0 -68.8 -62.0 200 200 230 170 189
6/4/2021 17:06:00 5.0 5.0 -68.1 -61.2 201 200 230 170 188
6/4/2021 17:07:00 5.0 5.0 -66.6 -61.0 199 200 230 170 187
6/4/2021 17:08:00 5.0 5.0 -65.7 -60.8 201 200 230 170 188
6/4/2021 17:09:00 5.0 5.0 -66.2 -60.8 201 200 230 170 189
6/4/2021 17:10:00 5.0 5.0 -67.4 -61.3 200 200 230 170 189
6/4/2021 17:11:00 5.0 5.0 -68.5 -61.8 199 200 230 170 189
6/4/2021 17:12:00 5.0 5.0 -68.8 -61.3 200 200 230 170 189
6/4/2021 17:13:00 5.0 5.0 -67.8 -60.9 200 200 230 170 188
6/4/2021 17:14:00 5.1 5.0 -66.6 -61.0 200 200 230 170 188
6/4/2021 17:15:00 5.1 5.0 -66.1 -61.0 199 200 230 170 188
6/4/2021 17:16:00 5.0 5.0 -66.9 -61.2 200 200 230 170 189
6/4/2021 17:17:00 5.0 5.0 -68.0 -61.7 200 200 230 170 189
6/4/2021 17:18:00 5.0 5.0 -68.7 -61.5 199 200 230 170 190
6/4/2021 17:19:00 5.0 5.0 -68.3 -61.0 201 200 230 170 189
6/4/2021 17:20:00 5.0 5.0 -67.1 -61.0 201 200 230 170 188
6/4/2021 17:21:00 5.0 5.0 -66.3 -61.0 199 200 230 170 188
6/4/2021 17:22:00 5.0 5.0 -66.6 -61.1 200 200 230 170 188

-------------------------------------------
Approved by Date Page: 59 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 17:23:00 5.0 5.0 -67.4 -61.6 201 200 230 170 189
6/4/2021 17:24:00 5.0 5.0 -68.2 -61.2 201 200 230 170 190
6/4/2021 17:25:00 5.0 5.0 -68.5 -61.0 201 200 230 170 191
6/4/2021 17:26:00 5.0 5.0 -68.0 -61.0 200 200 230 170 189
6/4/2021 17:27:00 5.0 5.0 -67.2 -61.0 200 200 230 170 188
6/4/2021 17:28:00 5.0 5.0 -66.9 -61.4 199 200 230 170 187
6/4/2021 17:29:00 5.0 5.0 -66.8 -61.5 199 200 230 170 188
6/4/2021 17:30:00 5.0 5.0 -67.1 -60.9 201 200 230 170 190
6/4/2021 17:31:00 5.0 5.0 -67.6 -61.0 199 200 230 170 191
6/4/2021 17:32:00 5.0 5.0 -68.0 -61.0 201 200 230 170 190
6/4/2021 17:33:00 5.0 5.0 -68.3 -61.2 201 200 230 170 188
6/4/2021 17:34:00 5.0 5.0 -67.6 -61.7 200 200 230 170 188
6/4/2021 17:35:00 5.0 5.0 -66.9 -61.2 200 200 230 170 188
6/4/2021 17:36:00 5.0 5.0 -66.5 -60.7 199 200 230 170 189
6/4/2021 17:37:00 5.0 5.0 -66.8 -60.9 200 200 230 170 191
6/4/2021 17:38:00 5.0 5.0 -67.7 -61.0 200 200 230 170 191
6/4/2021 17:39:00 5.0 5.0 -68.7 -61.4 200 200 230 170 189
6/4/2021 17:40:00 5.0 5.0 -68.5 -61.8 200 200 230 170 188
6/4/2021 17:41:00 5.0 5.0 -67.4 -61.3 200 200 230 170 188
6/4/2021 17:42:00 5.0 5.0 -66.5 -60.7 199 200 230 170 188
6/4/2021 17:43:00 5.0 5.0 -66.2 -61.0 201 200 230 170 190
6/4/2021 17:44:00 5.0 5.0 -66.9 -61.2 200 200 230 170 191
6/4/2021 17:45:00 5.0 5.0 -68.4 -61.5 199 200 230 170 190
6/4/2021 17:46:00 5.0 5.0 -69.1 -62.0 200 200 230 170 189
6/4/2021 17:47:00 5.0 5.0 -68.5 -61.7 199 200 230 170 188
6/4/2021 17:48:00 5.0 5.0 -67.2 -61.2 201 200 230 170 189
6/4/2021 17:49:00 5.0 5.0 -66.3 -61.4 199 200 230 170 188

-------------------------------------------
Approved by Date Page: 60 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 17:50:00 5.0 5.0 -66.3 -61.5 200 200 230 170 189
6/4/2021 17:51:00 5.0 5.0 -67.6 -61.8 200 200 230 170 190
6/4/2021 17:52:00 5.0 5.0 -68.8 -62.3 200 200 230 170 191
6/4/2021 17:53:00 5.0 5.0 -69.1 -62.0 200 200 230 170 190
6/4/2021 17:54:00 5.0 5.0 -68.3 -61.8 201 200 230 170 189
6/4/2021 17:55:00 5.0 5.0 -67.1 -61.8 201 200 230 170 189
6/4/2021 17:56:00 5.0 5.0 -66.6 -61.9 201 200 230 170 189
6/4/2021 17:57:00 5.0 5.0 -67.1 -62.3 200 200 230 170 189
6/4/2021 17:58:00 5.0 5.0 -67.8 -62.1 200 200 230 170 189
6/4/2021 17:59:00 5.0 5.0 -68.6 -61.4 199 200 230 170 191
6/4/2021 18:00:00 5.0 5.0 -68.8 -61.6 201 200 230 170 191
6/4/2021 18:01:00 5.0 5.0 -68.3 -61.7 201 200 230 170 189
6/4/2021 18:02:00 5.0 5.0 -67.8 -62.0 200 200 230 170 189
6/4/2021 18:03:00 5.0 5.0 -67.5 -62.4 199 200 230 170 188
6/4/2021 18:04:00 5.0 5.0 -67.4 -62.1 200 200 230 170 189
6/4/2021 18:05:00 5.0 5.0 -67.8 -61.6 200 200 230 170 190
6/4/2021 18:06:00 5.0 5.0 -68.4 -61.8 199 200 230 170 191
6/4/2021 18:07:00 5.0 5.0 -68.8 -62.0 199 200 230 170 190
6/4/2021 18:08:00 5.0 5.0 -68.8 -62.3 199 200 230 170 189
6/4/2021 18:09:00 5.0 5.0 -68.2 -62.8 200 200 230 170 189
6/4/2021 18:10:00 5.0 5.0 -67.6 -62.4 201 200 230 170 188
6/4/2021 18:11:00 5.0 5.0 -67.5 -62.0 201 200 230 170 189
6/4/2021 18:12:00 5.0 5.0 -67.9 -62.2 200 200 230 170 191
6/4/2021 18:13:00 5.0 5.0 -68.7 -62.3 201 200 230 170 191
6/4/2021 18:14:00 5.0 5.0 -69.5 -62.6 200 200 230 170 189
6/4/2021 18:15:00 5.0 5.0 -69.1 -63.1 199 200 230 170 188
6/4/2021 18:16:00 5.0 5.0 -68.2 -62.6 201 200 230 170 188

-------------------------------------------
Approved by Date Page: 61 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 18:17:00 5.0 5.0 -67.6 -62.3 201 200 230 170 188
6/4/2021 18:18:00 5.0 5.0 -67.6 -62.5 199 200 230 170 189
6/4/2021 18:19:00 5.0 5.0 -68.2 -62.6 200 200 230 170 190
6/4/2021 18:20:00 5.0 5.0 -69.4 -62.9 199 200 230 170 190
6/4/2021 18:21:00 5.0 5.0 -69.7 -63.3 200 200 230 170 189
6/4/2021 18:22:00 5.0 5.0 -68.9 -63.0 201 200 230 170 188
6/4/2021 18:23:00 5.0 5.0 -68.0 -62.6 201 200 230 170 188
6/4/2021 18:24:00 5.0 5.0 -67.5 -62.8 200 200 230 170 188
6/4/2021 18:25:00 5.0 5.0 -67.8 -63.0 200 200 230 170 189
6/4/2021 18:26:00 5.0 5.0 -68.9 -63.3 200 200 230 170 190
6/4/2021 18:27:00 5.0 5.0 -69.8 -63.6 200 200 230 170 190
6/4/2021 18:28:00 5.0 5.0 -69.7 -63.2 199 200 230 170 188
6/4/2021 18:29:00 5.0 5.0 -68.8 -62.9 199 200 230 170 187
6/4/2021 18:30:00 5.0 5.0 -67.9 -63.0 200 200 230 170 188
6/4/2021 18:31:00 5.0 5.0 -67.7 -63.1 200 200 230 170 188
6/4/2021 18:32:00 5.0 5.0 -68.1 -63.5 200 200 230 170 189
6/4/2021 18:33:00 5.0 5.0 -68.8 -63.6 200 200 230 170 189
6/4/2021 18:34:00 5.0 5.0 -69.4 -63.0 200 200 230 170 189
6/4/2021 18:35:00 5.0 5.0 -69.2 -62.8 201 200 230 170 188
6/4/2021 18:36:00 5.0 5.0 -68.3 -63.0 200 200 230 170 187
6/4/2021 18:37:00 5.0 5.0 -67.7 -63.2 199 200 230 170 186
6/4/2021 18:38:00 5.0 5.0 -67.7 -63.6 199 200 230 170 186
6/4/2021 18:39:00 5.0 5.0 -68.1 -63.6 201 200 230 170 187
6/4/2021 18:40:00 5.0 5.0 -68.8 -63.0 201 200 230 170 188
6/4/2021 18:41:00 5.0 5.0 -69.5 -63.0 199 200 230 170 189
6/4/2021 18:42:00 5.1 5.0 -69.6 -63.2 199 200 230 170 186
6/4/2021 18:43:00 5.1 5.0 -69.0 -63.4 199 200 230 170 185

-------------------------------------------
Approved by Date Page: 62 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 18:44:00 5.0 5.0 -68.2 -63.9 200 200 230 170 186
6/4/2021 18:45:00 5.0 5.0 -68.0 -63.8 200 200 230 170 184
6/4/2021 18:46:00 5.0 5.0 -68.1 -63.3 201 200 230 170 186
6/4/2021 18:47:00 5.0 5.0 -68.7 -63.1 200 200 230 170 187
6/4/2021 18:48:00 4.9 5.0 -69.4 -63.5 201 200 230 170 188
6/4/2021 18:49:00 4.9 5.0 -69.6 -63.7 200 200 230 170 187
6/4/2021 18:50:00 5.0 5.0 -69.1 -64.1 199 200 230 170 184
6/4/2021 18:51:00 5.0 5.0 -68.4 -64.3 201 200 230 170 184
6/4/2021 18:52:00 5.1 5.0 -68.0 -63.9 201 200 230 170 183
6/4/2021 18:53:00 5.1 5.0 -68.0 -63.5 199 200 230 170 183
6/4/2021 18:54:00 5.1 5.0 -68.5 -63.9 201 200 230 170 186
6/4/2021 18:55:00 5.0 5.0 -69.5 -64.2 200 200 230 170 187
6/4/2021 18:56:00 5.0 5.0 -70.3 -64.5 200 200 230 170 186
6/4/2021 18:57:00 5.0 5.0 -70.2 -64.7 200 200 230 170 184
6/4/2021 18:58:00 5.0 5.0 -68.8 -64.3 200 200 230 170 182
6/4/2021 18:59:00 5.0 5.0 -66.9 -63.7 200 200 230 170 182
6/4/2021 19:00:00 4.9 5.0 -66.3 -64.0 200 200 230 170 181
6/4/2021 19:01:00 5.0 5.0 -66.2 -64.4 199 200 230 170 180
6/4/2021 19:02:00 4.9 5.0 -66.6 -64.7 200 200 230 170 181
6/4/2021 19:03:00 5.0 5.0 -67.6 -65.0 200 200 230 170 181
6/4/2021 19:04:00 5.0 5.0 -68.9 -64.7 201 200 230 170 181
6/4/2021 19:05:00 5.0 5.0 -69.7 -64.2 199 200 230 170 181
6/4/2021 19:06:00 5.0 5.0 -69.6 -64.2 200 200 230 170 181
6/4/2021 19:07:00 5.0 5.0 -68.8 -64.7 200 200 230 170 180
6/4/2021 19:08:00 5.1 5.0 -68.4 -65.0 201 200 230 170 180
6/4/2021 19:09:00 5.1 5.0 -68.5 -65.3 201 200 230 170 180
6/4/2021 19:10:00 5.0 5.0 -68.9 -65.0 201 200 230 170 180

-------------------------------------------
Approved by Date Page: 63 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 19:11:00 5.0 5.0 -69.7 -64.4 200 200 230 170 181
6/4/2021 19:12:00 5.0 5.0 -70.4 -63.8 199 200 230 170 180
6/4/2021 19:13:00 4.9 5.0 -70.6 -64.3 200 200 230 170 180
6/4/2021 19:14:00 4.9 5.0 -69.9 -64.8 200 200 230 170 179
6/4/2021 19:15:00 4.9 5.0 -69.4 -65.2 199 200 230 170 179
6/4/2021 19:16:00 4.9 5.0 -69.1 -65.4 201 200 230 170 179
6/4/2021 19:17:00 5.0 5.0 -69.3 -65.1 201 200 230 170 179
6/4/2021 19:18:00 5.0 5.0 -69.9 -64.6 201 200 230 170 179
6/4/2021 19:19:00 5.1 5.0 -70.7 -64.1 199 200 230 170 179
6/4/2021 19:20:00 5.1 5.0 -71.0 -64.8 200 200 230 170 179
6/4/2021 19:21:00 5.1 5.0 -70.4 -65.4 201 200 230 170 178
6/4/2021 19:22:00 5.0 5.0 -68.8 -65.8 200 200 230 170 178
6/4/2021 19:23:00 5.0 5.0 -67.8 -65.9 201 200 230 170 177
6/4/2021 19:24:00 5.0 5.0 -67.6 -65.5 201 200 230 170 176
6/4/2021 19:25:00 5.0 5.0 -67.6 -64.9 200 200 230 170 176
6/4/2021 19:26:00 4.9 5.0 -68.0 -64.3 199 200 230 170 176
6/4/2021 19:27:00 4.9 5.0 -68.9 -63.6 201 200 230 170 176
6/4/2021 19:27:31 Alarm: CLOSE - Communication fail with SQL database.
6/4/2021 19:28:00 5.0 5.0 -70.1 -63.4 200 200 230 170 177
6/4/2021 19:29:00 5.0 5.0 -71.0 -64.2 200 200 230 170 177
6/4/2021 19:30:00 5.0 5.0 -71.4 -64.6 200 200 230 170 176
6/4/2021 19:31:00 5.0 5.0 -70.5 -65.0 199 200 230 170 176
6/4/2021 19:32:00 5.0 5.0 -68.8 -65.7 199 200 230 170 175
6/4/2021 19:33:00 5.0 5.0 -68.2 -66.0 201 200 230 170 175
6/4/2021 19:34:00 5.1 5.0 -68.4 -65.8 201 200 230 170 175
6/4/2021 19:35:00 5.1 5.0 -68.6 -65.6 199 200 230 170 174
6/4/2021 19:36:00 5.1 5.0 -69.1 -66.1 200 200 230 170 175

-------------------------------------------
Approved by Date Page: 64 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 19:37:00 5.0 5.0 -70.3 -66.4 200 200 230 170 175
6/4/2021 19:38:00 5.0 5.0 -71.6 -66.8 199 200 230 170 174
6/4/2021 19:39:00 5.0 5.0 -72.6 -67.4 199 200 230 170 174
6/4/2021 19:40:00 5.0 5.0 -72.5 -67.5 199 200 230 170 173
6/4/2021 19:41:00 5.0 5.0 -71.0 -67.2 199 200 230 170 173
6/4/2021 19:42:00 4.9 5.0 -69.1 -67.1 200 200 230 170 174
6/4/2021 19:43:00 4.9 5.0 -68.8 -67.5 201 200 230 170 173
6/4/2021 19:44:00 5.0 5.0 -69.1 -68.0 201 200 230 170 173
6/4/2021 19:45:00 5.0 5.0 -69.6 -68.4 201 200 230 170 173
6/4/2021 19:46:00 5.1 5.0 -70.1 -68.2 201 200 230 170 173
6/4/2021 19:47:00 5.1 5.0 -71.1 -67.8 199 200 230 170 172
6/4/2021 19:48:00 5.1 5.0 -72.3 -67.3 200 200 230 170 173
6/4/2021 19:49:00 5.0 5.0 -73.2 -67.2 200 200 230 170 173
6/4/2021 19:50:00 5.0 5.0 -73.1 -67.8 201 200 230 170 172
6/4/2021 19:51:00 5.0 5.0 -71.7 -68.2 201 200 230 170 172
6/4/2021 19:52:00 5.0 5.0 -69.9 -68.7 200 200 230 170 172
6/4/2021 19:53:00 4.9 5.0 -69.2 -68.6 200 200 230 170 172
6/4/2021 19:54:00 4.9 5.0 -69.6 -68.2 200 200 230 170 172
6/4/2021 19:55:00 5.0 5.0 -70.2 -67.8 201 200 230 170 172
6/4/2021 19:56:00 5.0 5.0 -70.7 -67.3 201 200 230 170 171
6/4/2021 19:57:00 5.0 5.0 -71.5 -66.8 201 200 230 170 171
6/4/2021 19:58:00 5.0 5.0 -72.6 -66.4 201 200 230 170 171
6/4/2021 19:59:00 5.0 5.0 -73.7 -67.0 200 200 230 170 171
6/4/2021 20:00:00 5.0 5.0 -74.4 -67.5 201 200 230 170 171
6/4/2021 20:01:00 5.0 5.0 -74.0 -67.8 201 200 230 170 171
6/4/2021 20:02:00 5.1 5.0 -72.6 -68.4 199 200 230 170 170
6/4/2021 20:03:00 5.1 5.0 -70.9 -68.9 201 200 230 170 171

-------------------------------------------
Approved by Date Page: 65 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 20:04:00 5.0 5.0 -70.0 -68.8 200 200 230 170 170
6/4/2021 20:05:00 5.0 5.0 -70.5 -68.5 199 200 230 170 170
6/4/2021 20:06:00 4.9 5.0 -71.3 -68.2 199 200 230 170 170
6/4/2021 20:07:00 5.0 5.0 -72.4 -68.6 201 200 230 170 171
6/4/2021 20:08:00 5.0 5.0 -72.8 -69.2 201 200 230 170 171
6/4/2021 20:09:00 5.0 5.0 -73.4 -69.7 199 200 230 170 170
6/4/2021 20:10:00 5.0 5.0 -74.2 -70.2 199 200 230 170 170
6/4/2021 20:11:00 5.0 5.0 -75.1 -70.3 201 200 230 170 170
6/4/2021 20:12:00 5.1 5.0 -75.8 -70.2 200 200 230 170 170
6/4/2021 20:13:00 5.1 5.0 -75.8 -69.9 201 200 230 170 170
6/4/2021 20:14:00 5.0 5.0 -74.7 -69.5 199 200 230 170 170
6/4/2021 20:15:00 5.0 5.0 -73.0 -69.2 201 200 230 170 170
6/4/2021 20:16:00 5.0 5.0 -71.3 -68.9 200 200 230 170 170
6/4/2021 20:17:00 5.0 5.0 -70.5 -68.6 199 200 230 170 170
6/4/2021 20:18:00 5.0 5.0 -71.2 -68.3 201 200 230 170 170
6/4/2021 20:19:00 5.0 5.0 -72.1 -68.0 200 200 230 170 169
6/4/2021 20:20:00 5.0 5.0 -73.3 -68.8 199 200 230 170 170
6/4/2021 20:21:00 4.9 5.0 -73.8 -69.4 200 200 230 170 170
6/4/2021 20:22:00 5.0 5.0 -74.1 -69.5 199 200 230 170 169
6/4/2021 20:23:00 5.0 5.0 -74.7 -69.2 201 200 230 170 170
6/4/2021 20:24:00 5.0 5.0 -75.4 -68.9 199 200 230 170 169
6/4/2021 20:25:00 5.0 5.0 -76.1 -68.6 201 200 230 170 170
6/4/2021 20:26:00 5.0 5.0 -76.4 -68.5 199 200 230 170 169
6/4/2021 20:27:00 5.0 5.0 -76.0 -68.4 201 200 230 170 170
6/4/2021 20:28:00 5.1 5.0 -74.8 -68.3 199 200 230 170 169
6/4/2021 20:29:00 5.0 5.0 -73.3 -68.2 200 200 230 170 170
6/4/2021 20:30:00 5.1 5.0 -71.8 -68.1 200 200 230 170 170

-------------------------------------------
Approved by Date Page: 66 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 20:31:00 5.0 5.0 -71.7 -67.9 200 200 230 170 170
6/4/2021 20:32:00 5.0 5.0 -72.6 -67.8 200 200 230 170 169
6/4/2021 20:33:00 5.0 5.0 -73.5 -67.8 201 200 230 170 170
6/4/2021 20:34:00 5.0 5.0 -74.2 -67.7 199 200 230 170 169
6/4/2021 20:35:00 5.0 5.0 -74.9 -67.6 200 200 230 170 169
6/4/2021 20:36:00 5.0 5.0 -75.3 -67.6 200 200 230 170 170
6/4/2021 20:37:00 4.9 5.0 -75.6 -67.5 199 200 230 170 169
6/4/2021 20:38:00 5.0 5.0 -75.8 -67.4 201 200 230 170 170
6/4/2021 20:39:00 5.0 5.0 -76.1 -68.6 199 200 230 170 169
6/4/2021 20:40:00 5.0 5.0 -76.5 -69.4 200 200 230 170 170
6/4/2021 20:41:00 5.0 5.0 -76.8 -69.5 200 200 230 170 170
6/4/2021 20:42:00 5.0 5.0 -77.1 -69.4 201 200 230 170 170
6/4/2021 20:43:00 5.0 5.0 -77.3 -69.3 201 200 230 170 169
6/4/2021 20:44:00 5.0 5.0 -77.4 -69.1 200 200 230 170 170
6/4/2021 20:45:00 5.0 5.0 -77.6 -68.9 199 200 230 170 169
6/4/2021 20:46:00 5.1 5.0 -77.7 -68.8 200 200 230 170 170
6/4/2021 20:47:00 5.0 5.0 -77.5 -68.7 199 200 230 170 169
6/4/2021 20:48:00 5.0 5.0 -77.6 -68.5 201 200 230 170 170
6/4/2021 20:49:00 5.0 5.0 -77.5 -68.4 199 200 230 170 169
6/4/2021 20:50:00 4.9 5.0 -77.6 -68.2 199 200 230 170 169
6/4/2021 20:51:00 4.9 5.0 -77.7 -68.1 200 200 230 170 170
6/4/2021 20:52:00 5.0 5.0 -77.6 -68.1 199 200 230 170 169
6/4/2021 20:53:00 5.0 5.0 -76.8 -68.1 201 200 230 170 170
6/4/2021 20:54:00 5.0 5.0 -75.7 -68.1 201 200 230 170 170
6/4/2021 20:55:00 5.1 5.0 -74.5 -68.1 201 200 230 170 170
6/4/2021 20:56:00 5.1 5.0 -74.0 -68.0 199 200 230 170 169
6/4/2021 20:57:00 5.0 5.0 -74.7 -68.4 200 200 230 170 169

-------------------------------------------
Approved by Date Page: 67 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 20:58:00 4.9 5.0 -75.5 -70.2 200 200 230 170 170
6/4/2021 20:59:00 4.9 5.0 -76.3 -71.6 200 200 230 170 170
6/4/2021 21:00:00 4.9 5.0 -76.8 -72.0 199 200 230 170 170
6/4/2021 21:01:00 5.0 5.0 -77.0 -72.1 199 200 230 170 169
6/4/2021 21:02:00 5.0 5.0 -77.2 -71.9 201 200 230 170 170
6/4/2021 21:03:00 5.0 5.0 -77.5 -71.7 201 200 230 170 170
6/4/2021 21:04:00 5.1 5.0 -77.8 -71.5 201 200 230 170 170
6/4/2021 21:05:00 5.1 5.0 -77.7 -71.4 200 200 230 170 170
6/4/2021 21:06:00 5.0 5.0 -76.9 -71.1 199 200 230 170 170
6/4/2021 21:07:00 5.0 5.0 -76.0 -71.0 201 200 230 170 170
6/4/2021 21:08:00 4.9 5.0 -75.0 -70.8 200 200 230 170 170
6/4/2021 21:09:00 4.9 5.0 -74.2 -70.7 199 200 230 170 170
6/4/2021 21:10:00 5.0 5.0 -75.1 -71.5 199 200 230 170 170
6/4/2021 21:11:00 5.0 5.0 -76.4 -72.7 201 200 230 170 170
6/4/2021 21:12:00 5.0 5.0 -77.2 -73.7 199 200 230 170 169
6/4/2021 21:13:00 5.0 5.0 -77.9 -74.3 201 200 230 170 170
6/4/2021 21:14:00 5.0 5.0 -78.1 -74.4 199 200 230 170 170
6/4/2021 21:15:00 5.1 5.0 -77.3 -74.2 200 200 230 170 170
6/4/2021 21:16:00 5.0 5.0 -76.1 -74.0 200 200 230 170 170
6/4/2021 21:17:00 5.0 5.0 -74.8 -73.9 201 200 230 170 170
6/4/2021 21:18:00 5.0 5.0 -74.5 -74.5 199 200 230 170 169
6/4/2021 21:19:00 5.0 5.0 -75.8 -75.1 201 200 230 170 170
6/4/2021 21:20:00 5.0 5.0 -77.1 -75.1 201 200 230 170 171
6/4/2021 21:21:00 5.0 5.0 -78.5 -74.9 200 200 230 170 171
6/4/2021 21:22:00 5.0 5.0 -79.8 -74.7 200 200 230 170 170
6/4/2021 21:23:00 5.0 5.0 -79.8 -74.7 199 200 230 170 169
6/4/2021 21:24:00 5.0 5.0 -78.8 -75.3 199 200 230 170 170

-------------------------------------------
Approved by Date Page: 68 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 21:25:00 5.0 5.0 -77.7 -75.8 201 200 230 170 171
6/4/2021 21:26:00 5.0 5.0 -76.6 -75.9 201 200 230 170 171
6/4/2021 21:27:00 5.0 5.0 -75.5 -75.8 199 200 230 170 170
6/4/2021 21:28:00 5.0 5.0 -74.6 -75.6 199 200 230 170 170
6/4/2021 21:29:00 5.0 5.0 -73.9 -75.3 201 200 230 170 171
6/4/2021 21:30:00 5.0 5.0 -74.8 -75.6 199 200 230 170 169
6/4/2021 21:31:00 5.0 5.0 -76.4 -76.2 199 200 230 170 169
6/4/2021 21:32:00 5.0 5.0 -77.9 -76.6 201 200 230 170 170
6/4/2021 21:33:00 5.0 5.0 -78.8 -76.7 201 200 230 170 170
6/4/2021 21:34:00 5.0 5.0 -79.3 -76.5 199 200 230 170 168
6/4/2021 21:35:00 5.0 5.0 -78.9 -76.7 201 200 230 170 170
6/4/2021 21:36:00 5.0 5.0 -78.0 -77.0 199 200 230 170 170
6/4/2021 21:37:00 5.0 5.0 -76.9 -77.2 199 200 230 170 169
6/4/2021 21:38:00 5.0 5.0 -75.9 -77.4 200 200 230 170 171
6/4/2021 21:39:00 5.0 5.0 -74.9 -77.7 199 200 230 170 168
6/4/2021 21:40:00 5.0 5.0 -74.2 -77.8 202 200 230 170 171
6/4/2021 21:41:00 5.0 5.0 -75.5 -77.7 199 200 230 170 169
6/4/2021 21:42:00 5.0 5.0 -77.2 -77.6 199 200 230 170 169
6/4/2021 21:43:00 5.1 5.0 -78.7 -77.7 202 200 230 170 171
6/4/2021 21:44:00 5.1 5.0 -79.6 -77.8 202 200 230 170 172
6/4/2021 21:45:00 5.1 5.0 -80.2 -78.0 200 200 230 170 170
6/4/2021 21:46:00 5.1 5.0 -80.5 -77.8 199 200 230 170 169
6/4/2021 21:47:00 5.0 5.0 -80.3 -77.2 199 200 230 170 168
6/4/2021 21:48:00 5.0 5.0 -79.5 -77.3 199 200 230 170 168
6/4/2021 21:49:00 5.0 5.0 -78.3 -77.5 199 200 230 170 167
6/4/2021 21:50:00 5.0 5.0 -77.2 -77.8 199 200 230 170 167
6/4/2021 21:51:00 5.0 5.0 -76.2 -77.5 197 200 230 170 167

-------------------------------------------
Approved by Date Page: 69 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 21:52:00 5.0 5.0 -76.3 -77.5 205 200 230 170 174
6/4/2021 21:53:00 5.0 5.0 -78.0 -77.9 193 200 230 170 163
6/4/2021 21:54:00 5.0 5.0 -79.5 -78.0 220 200 230 170 192
6/4/2021 21:55:00 5.0 5.0 -80.7 -77.7 225 200 230 170 198
6/4/2021 21:56:00 5.0 5.0 -81.6 -77.4 178 200 230 170 146
6/4/2021 21:57:00 5.0 5.0 -82.2 -77.6 197 200 230 170 165
6/4/2021 21:58:00 5.0 5.0 -82.3 -78.0 227 200 230 170 199
6/4/2021 21:59:00 5.0 5.0 -81.5 -78.0 166 200 230 170 133
6/4/2021 22:00:00 5.0 5.0 -80.4 -77.8 210 200 230 170 181
6/4/2021 22:01:00 5.0 5.0 -79.3 -77.9 220 200 230 170 193
6/4/2021 22:02:00 4.9 5.0 -78.3 -77.9 179 200 230 170 145
6/4/2021 22:03:00 5.0 5.0 -77.4 -77.8 225 200 230 170 199
6/4/2021 22:04:00 4.9 5.0 -76.6 -77.8 171 200 230 170 139
6/4/2021 22:05:00 5.0 5.0 -75.9 -77.9 215 200 230 170 186
6/4/2021 22:06:00 4.9 5.0 -75.1 -78.1 212 200 230 170 182
6/4/2021 22:07:00 5.0 5.0 -74.5 -78.1 196 200 230 170 164
6/4/2021 22:08:00 4.9 5.0 -75.7 -78.2 225 200 230 170 198
6/4/2021 22:09:00 4.8 5.0 -76.7 -77.9 183 200 230 170 151
6/4/2021 22:10:00 5.0 5.0 -77.2 -77.9 227 200 230 170 200
6/4/2021 22:10:55 Audit: - A_SQLCOMMFAIL ALARM is acknowledged by IDIN.
6/4/2021 22:11:00 5.1 5.0 -77.3 -78.2 177 200 230 170 144
6/4/2021 22:11:13 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 15 by IDIN.
6/4/2021 22:11:22 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 16 by IDIN.
6/4/2021 22:12:00 5.1 5.0 -76.9 -78.3 227 200 230 170 200
6/4/2021 22:13:00 5.1 5.0 -76.1 -78.1 173 200 230 170 141
6/4/2021 22:14:00 5.1 5.0 -75.3 -78.0 227 200 230 170 200
6/4/2021 22:15:00 5.1 5.0 -74.5 -77.9 175 200 230 170 143

-------------------------------------------
Approved by Date Page: 70 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 22:16:00 5.0 5.0 -73.7 -77.9 227 200 230 170 200
6/4/2021 22:17:00 5.0 5.0 -73.1 -77.8 180 200 230 170 149
6/4/2021 22:18:00 5.0 5.0 -73.7 -78.0 226 200 230 170 199
6/4/2021 22:19:00 5.1 5.0 -74.5 -78.0 192 200 230 170 160
6/4/2021 22:20:00 5.1 5.0 -74.9 -78.0 221 200 230 170 193
6/4/2021 22:21:00 5.0 5.0 -74.6 -77.9 204 200 230 170 175
6/4/2021 22:22:00 5.1 5.0 -73.9 -78.0 200 200 230 170 173
6/4/2021 22:23:00 5.1 5.0 -73.1 -78.0 219 200 230 170 190
6/4/2021 22:24:00 4.9 5.0 -72.3 -78.1 166 200 230 170 132
6/4/2021 22:25:00 4.9 5.0 -71.5 -78.1 225 200 230 170 199
6/4/2021 22:26:00 4.9 5.0 -72.0 -78.0 181 200 230 170 150
6/4/2021 22:27:00 5.0 5.0 -71.4 -78.0 222 200 230 170 194
6/4/2021 22:28:00 5.0 5.0 -71.2 -77.9 207 200 230 170 179
6/4/2021 22:29:00 5.0 5.0 -71.4 -77.8 180 200 230 170 150
6/4/2021 22:30:00 5.0 5.0 -71.3 -77.8 225 200 230 170 198
6/4/2021 22:31:00 5.1 5.0 -70.9 -77.8 179 200 230 170 147
6/4/2021 22:32:00 5.1 5.0 -70.7 -77.9 224 200 230 170 196
6/4/2021 22:33:00 5.1 5.0 -70.7 -77.8 212 200 230 170 184
6/4/2021 22:34:00 5.1 5.0 -70.9 -77.8 166 200 230 170 134
6/4/2021 22:35:00 5.0 5.0 -71.0 -77.7 227 200 230 170 201
6/4/2021 22:35:01 Alarm: CLOSE - Communication fail with SQL database.
6/4/2021 22:36:00 5.0 5.0 -70.8 -77.6 199 200 230 170 170
6/4/2021 22:37:00 5.1 5.0 -70.0 -77.6 188 200 230 170 162
6/4/2021 22:38:00 5.1 5.0 -69.1 -77.7 225 200 230 170 200
6/4/2021 22:39:00 5.1 5.0 -68.2 -77.7 190 200 230 170 162
6/4/2021 22:40:00 4.9 5.0 -67.4 -77.8 205 200 230 170 178
6/4/2021 22:41:00 4.9 5.0 -66.6 -77.6 222 200 230 170 198

-------------------------------------------
Approved by Date Page: 71 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 22:42:00 4.9 5.0 -65.9 -77.5 185 200 230 170 157
6/4/2021 22:43:00 4.9 5.0 -65.3 -77.3 208 200 230 170 183
6/4/2021 22:44:00 5.1 5.0 -65.4 -77.3 224 200 230 170 199
6/4/2021 22:45:00 5.1 5.0 -65.9 -77.3 190 200 230 170 161
6/4/2021 22:46:00 5.1 5.0 -66.0 -77.2 197 200 230 170 170
6/4/2021 22:47:00 5.0 5.0 -66.3 -77.3 225 200 230 170 201
6/4/2021 22:48:00 5.1 5.0 -66.6 -77.2 198 200 230 170 171
6/4/2021 22:49:00 5.0 5.0 -66.6 -77.1 175 200 230 170 147
6/4/2021 22:50:00 5.0 5.0 -66.0 -77.0 225 200 230 170 202
6/4/2021 22:51:00 5.0 5.0 -65.3 -76.9 209 200 230 170 183
6/4/2021 22:52:00 5.0 5.0 -64.6 -76.8 167 200 230 170 137
6/4/2021 22:53:00 4.9 5.0 -64.1 -76.9 225 200 230 170 201
6/4/2021 22:54:00 4.9 5.0 -63.5 -76.9 219 200 230 170 195
6/4/2021 22:55:00 5.0 5.0 -63.9 -76.7 186 200 230 170 160
6/4/2021 22:56:00 5.0 5.0 -64.5 -76.6 188 200 230 170 163
6/4/2021 22:57:00 5.1 5.0 -64.8 -76.6 225 200 230 170 202
6/4/2021 22:58:00 5.0 5.0 -64.7 -76.5 206 200 230 170 182
6/4/2021 22:59:00 5.1 5.0 -64.2 -76.6 167 200 230 170 138
6/4/2021 23:00:00 5.0 5.0 -63.7 -76.5 223 200 230 170 198
6/4/2021 23:01:00 5.1 5.0 -63.2 -76.4 220 200 230 170 195
6/4/2021 23:02:00 5.0 5.0 -62.9 -76.3 192 200 230 170 164
6/4/2021 23:03:00 5.0 5.0 -63.6 -76.2 175 200 230 170 147
6/4/2021 23:04:00 4.9 5.0 -64.1 -76.4 225 200 230 170 201
6/4/2021 23:05:00 4.9 5.0 -64.4 -76.4 215 200 230 170 190
6/4/2021 23:06:00 4.9 5.0 -64.7 -76.4 183 200 230 170 155
6/4/2021 23:07:00 4.8 5.0 -64.5 -76.3 196 200 230 170 169
6/4/2021 23:08:00 4.9 5.0 -64.1 -76.2 225 200 230 170 200

-------------------------------------------
Approved by Date Page: 72 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 23:09:00 4.9 5.0 -63.6 -76.1 211 200 230 170 185
6/4/2021 23:10:00 4.9 5.0 -63.2 -76.1 179 200 230 170 148
6/4/2021 23:11:00 4.9 5.0 -62.9 -76.1 198 200 230 170 171
6/4/2021 23:12:00 4.9 5.0 -63.2 -76.1 225 200 230 170 200
6/4/2021 23:13:00 4.9 5.0 -63.7 -76.1 210 200 230 170 184
6/4/2021 23:14:00 4.9 5.0 -63.9 -76.1 179 200 230 170 150
6/4/2021 23:15:00 5.0 5.0 -63.6 -76.1 198 200 230 170 170
6/4/2021 23:15:38 Audit: - A_SQLCOMMFAIL ALARM is acknowledged by IDIN.
6/4/2021 23:16:00 5.1 5.0 -63.1 -76.1 225 200 230 170 201
6/4/2021 23:17:00 5.1 5.0 -62.7 -76.1 214 200 230 170 189
6/4/2021 23:18:00 4.9 5.0 -62.3 -76.0 191 200 230 170 164
6/4/2021 23:19:00 4.9 5.0 -61.9 -75.9 173 200 230 170 146
6/4/2021 23:20:00 4.8 5.0 -62.6 -75.9 225 200 230 170 201
6/4/2021 23:21:00 4.9 5.0 -63.1 -75.8 219 200 230 170 197
6/4/2021 23:22:00 4.9 5.0 -63.4 -75.9 202 200 230 170 177
6/4/2021 23:23:00 4.9 5.0 -63.3 -75.9 172 200 230 170 144
6/4/2021 23:24:00 4.9 5.0 -62.8 -75.9 206 200 230 170 183
6/4/2021 23:25:00 4.9 5.0 -62.4 -75.9 225 200 230 170 202
6/4/2021 23:26:00 4.9 5.0 -62.0 -75.9 214 200 230 170 191
6/4/2021 23:27:00 4.9 5.0 -61.7 -75.9 192 200 230 170 168
6/4/2021 23:28:00 4.8 5.0 -61.5 -75.9 166 200 230 170 138
6/4/2021 23:29:00 4.9 5.0 -61.5 -75.9 219 200 230 170 197
6/4/2021 23:30:00 4.8 5.0 -62.1 -75.9 224 200 230 170 201
6/4/2021 23:31:00 4.9 5.0 -62.8 -75.8 212 200 230 170 188
6/4/2021 23:32:00 4.9 5.0 -62.8 -75.9 189 200 230 170 163
6/4/2021 23:33:00 4.9 5.0 -62.6 -75.9 166 200 230 170 136
6/4/2021 23:34:00 5.0 5.0 -62.3 -75.8 222 200 230 170 198

-------------------------------------------
Approved by Date Page: 73 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/4/2021 23:35:00 5.1 5.0 -62.9 -75.8 222 200 230 170 198
6/4/2021 23:36:00 5.1 5.0 -63.6 -75.7 209 200 230 170 183
6/4/2021 23:37:00 5.1 5.0 -64.2 -75.7 185 200 230 170 158
6/4/2021 23:38:00 5.0 5.0 -64.7 -75.7 170 200 230 170 139
6/4/2021 23:39:00 5.1 5.0 -64.7 -75.7 223 200 230 170 198
6/4/2021 23:40:00 5.0 5.0 -64.4 -75.7 222 200 230 170 196
6/4/2021 23:41:00 5.0 5.0 -64.1 -75.7 207 200 230 170 182
6/4/2021 23:42:00 5.1 5.0 -64.6 -75.7 186 200 230 170 157
6/4/2021 23:43:00 5.1 5.0 -65.1 -75.7 169 200 230 170 139
6/4/2021 23:44:00 5.1 5.0 -65.6 -75.8 222 200 230 170 196
6/4/2021 23:45:00 5.1 5.0 -65.5 -75.7 221 200 230 170 195
6/4/2021 23:46:00 5.1 5.0 -65.0 -75.8 209 200 230 170 183
6/4/2021 23:47:00 5.1 5.0 -64.5 -75.8 191 200 230 170 162
6/4/2021 23:48:00 5.0 5.0 -64.0 -75.7 165 200 230 170 136
6/4/2021 23:49:00 5.1 5.0 -63.6 -75.6 217 200 230 170 191
6/4/2021 23:50:00 5.0 5.0 -63.3 -75.6 224 200 230 170 198
6/4/2021 23:51:00 5.1 5.0 -63.8 -75.6 212 200 230 170 188
6/4/2021 23:52:00 5.1 5.0 -64.2 -75.6 197 200 230 170 169
6/4/2021 23:53:00 5.1 5.0 -64.5 -75.7 174 200 230 170 144
6/4/2021 23:54:00 4.9 5.0 -64.8 -75.6 193 200 230 170 168
6/4/2021 23:55:00 4.9 5.0 -65.0 -75.6 225 200 230 170 199
6/4/2021 23:56:00 5.1 5.0 -65.0 -75.6 219 200 230 170 192
6/4/2021 23:57:00 5.1 5.0 -64.5 -75.7 205 200 230 170 179
6/4/2021 23:58:00 5.0 5.0 -64.0 -75.7 187 200 230 170 159
6/4/2021 23:59:00 5.1 5.0 -63.5 -75.7 167 200 230 170 136
6/5/2021 00:00:00 5.1 5.0 -62.9 -75.7 215 200 230 170 190
6/5/2021 00:01:00 5.1 5.0 -62.5 -75.7 224 200 230 170 199

-------------------------------------------
Approved by Date Page: 74 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 00:01:02 Audit: - Security Synchronizer: Beginning security synchronization process by SecuritySyochronizer.
Audit: - Security Synchronizer: Function is not enabled on this node, check license/key by SecuritySyochronizer.
6/5/2021 00:02:00 4.9 5.0 -63.1 -75.6 214 200 230 170 189
6/5/2021 00:03:00 5.1 5.0 -63.7 -75.6 201 200 230 170 174
6/5/2021 00:04:00 5.1 5.0 -63.7 -75.7 181 200 230 170 152
6/5/2021 00:05:00 5.1 5.0 -63.4 -75.7 174 200 230 170 144
6/5/2021 00:06:00 4.9 5.0 -63.1 -75.6 222 200 230 170 196
6/5/2021 00:07:00 4.9 5.0 -63.6 -75.7 220 200 230 170 195
6/5/2021 00:08:00 5.1 5.0 -64.1 -75.7 210 200 230 170 184
6/5/2021 00:09:00 5.1 5.0 -64.2 -75.8 199 200 230 170 171
6/5/2021 00:10:00 5.1 5.0 -63.8 -75.8 178 200 230 170 148
6/5/2021 00:11:00 4.9 5.0 -63.4 -75.7 183 200 230 170 154
6/5/2021 00:12:00 5.1 5.0 -62.9 -75.7 223 200 230 170 196
6/5/2021 00:13:00 5.1 5.0 -62.9 -75.8 219 200 230 170 194
6/5/2021 00:14:00 4.9 5.0 -63.6 -75.6 209 200 230 170 183
6/5/2021 00:15:00 4.9 5.0 -64.1 -75.7 196 200 230 170 168
6/5/2021 00:16:00 4.9 5.0 -64.5 -75.8 177 200 230 170 147
6/5/2021 00:17:00 5.1 5.0 -64.3 -75.8 183 200 230 170 154
6/5/2021 00:18:00 5.1 5.0 -63.9 -75.9 222 200 230 170 196
6/5/2021 00:19:00 4.9 5.0 -63.4 -75.8 219 200 230 170 194
6/5/2021 00:20:00 5.1 5.0 -63.0 -75.8 209 200 230 170 183
6/5/2021 00:21:00 5.1 5.0 -62.6 -75.9 196 200 230 170 169
6/5/2021 00:22:00 4.9 5.0 -62.6 -75.9 179 200 230 170 151
6/5/2021 00:23:00 5.1 5.0 -63.1 -75.9 178 200 230 170 149
6/5/2021 00:24:00 4.9 5.0 -63.7 -75.8 217 200 230 170 191
6/5/2021 00:25:00 4.9 5.0 -64.2 -75.9 224 200 230 170 199
6/5/2021 00:26:00 5.0 5.0 -64.5 -75.9 217 200 230 170 192

-------------------------------------------
Approved by Date Page: 75 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 00:27:00 5.1 5.0 -64.2 -76.0 208 200 230 170 183
6/5/2021 00:28:00 5.0 5.0 -63.7 -75.9 198 200 230 170 170
6/5/2021 00:29:00 5.1 5.0 -63.1 -75.9 184 200 230 170 155
6/5/2021 00:30:00 4.9 5.0 -62.7 -75.9 169 200 230 170 139
6/5/2021 00:31:00 4.9 5.0 -62.3 -75.9 194 200 230 170 168
6/5/2021 00:32:00 5.1 5.0 -62.8 -75.9 223 200 230 170 196
6/5/2021 00:33:00 5.1 5.0 -63.5 -75.9 219 200 230 170 195
6/5/2021 00:34:00 4.9 5.0 -64.0 -75.9 212 200 230 170 186
6/5/2021 00:35:00 4.9 5.0 -64.1 -75.9 201 200 230 170 175
6/5/2021 00:36:00 5.1 5.0 -63.8 -75.9 189 200 230 170 160
6/5/2021 00:37:00 5.0 5.0 -63.4 -75.8 174 200 230 170 144
6/5/2021 00:38:00 5.1 5.0 -63.0 -75.8 180 200 230 170 152
6/5/2021 00:39:00 5.1 5.0 -62.6 -75.9 218 200 230 170 192
6/5/2021 00:40:00 4.9 5.0 -62.4 -75.8 220 200 230 170 195
6/5/2021 00:41:00 4.9 5.0 -63.0 -75.9 212 200 230 170 187
6/5/2021 00:42:00 5.1 5.0 -63.7 -75.9 202 200 230 170 175
6/5/2021 00:43:00 5.1 5.0 -63.9 -75.9 187 200 230 170 159
6/5/2021 00:44:00 4.9 5.0 -63.7 -75.8 172 200 230 170 142
6/5/2021 00:45:00 5.1 5.0 -63.3 -75.9 202 200 230 170 176
6/5/2021 00:46:00 5.1 5.0 -63.1 -75.9 220 200 230 170 195
6/5/2021 00:47:00 4.9 5.0 -63.6 -75.9 211 200 230 170 185
6/5/2021 00:48:00 5.1 5.0 -63.9 -75.9 196 200 230 170 169
6/5/2021 00:49:00 5.1 5.0 -64.0 -75.9 179 200 230 170 148
6/5/2021 00:50:00 4.9 5.0 -64.1 -75.8 202 200 230 170 176
6/5/2021 00:51:00 5.1 5.0 -63.9 -75.8 219 200 230 170 192
6/5/2021 00:52:00 5.1 5.0 -63.4 -75.8 204 200 230 170 178
6/5/2021 00:53:00 4.9 5.0 -63.0 -75.7 185 200 230 170 158

-------------------------------------------
Approved by Date Page: 76 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 00:54:00 4.9 5.0 -62.6 -75.8 190 200 230 170 162
6/5/2021 00:55:00 5.1 5.0 -62.2 -75.7 219 200 230 170 193
6/5/2021 00:56:00 4.9 5.0 -61.9 -75.6 204 200 230 170 178
6/5/2021 00:57:00 4.9 5.0 -62.6 -75.7 184 200 230 170 155
6/5/2021 00:58:00 5.1 5.0 -63.2 -75.7 202 200 230 170 175
6/5/2021 00:59:00 5.0 5.0 -63.7 -75.6 214 200 230 170 189
6/5/2021 01:00:00 4.9 5.0 -63.7 -75.7 197 200 230 170 168
6/5/2021 01:01:00 5.1 5.0 -63.5 -75.7 182 200 230 170 153
6/5/2021 01:02:00 5.0 5.0 -63.2 -75.6 217 200 230 170 190
6/5/2021 01:03:00 5.1 5.0 -63.2 -75.6 197 200 230 170 170
6/5/2021 01:04:00 5.1 5.0 -63.7 -75.7 187 200 230 170 160
6/5/2021 01:05:00 5.0 5.0 -63.5 -75.7 212 200 230 170 188
6/5/2021 01:06:00 5.1 5.0 -63.1 -75.7 192 200 230 170 163
6/5/2021 01:07:00 5.1 5.0 -62.7 -75.8 205 200 230 170 180
6/5/2021 01:08:00 4.9 5.0 -62.3 -75.7 205 200 230 170 180
6/5/2021 01:09:00 5.1 5.0 -62.0 -75.6 184 200 230 170 154
6/5/2021 01:10:00 5.0 5.0 -62.0 -75.6 214 200 230 170 189
6/5/2021 01:11:00 5.1 5.0 -62.8 -75.6 192 200 230 170 165
6/5/2021 01:12:00 5.1 5.0 -63.1 -75.7 209 200 230 170 183
6/5/2021 01:13:00 5.0 5.0 -63.3 -75.6 199 200 230 170 171
6/5/2021 01:14:00 5.1 5.0 -63.7 -75.6 204 200 230 170 177
6/5/2021 01:15:00 5.1 5.0 -63.7 -75.6 199 200 230 170 172
6/5/2021 01:16:00 5.0 5.0 -63.2 -75.7 205 200 230 170 179
6/5/2021 01:17:00 5.1 5.0 -62.8 -75.7 196 200 230 170 168
6/5/2021 01:18:00 5.1 5.0 -62.3 -75.8 209 200 230 170 182
6/5/2021 01:19:00 5.0 5.0 -62.0 -75.7 192 200 230 170 164
6/5/2021 01:20:00 5.1 5.0 -61.8 -75.7 209 200 230 170 182

-------------------------------------------
Approved by Date Page: 77 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 01:21:00 4.9 5.0 -62.6 -75.6 192 200 230 170 164
6/5/2021 01:22:00 4.9 5.0 -63.1 -75.7 205 200 230 170 179
6/5/2021 01:23:00 5.1 5.0 -63.1 -75.7 194 200 230 170 166
6/5/2021 01:24:00 4.9 5.0 -62.8 -75.7 204 200 230 170 177
6/5/2021 01:25:00 5.1 5.0 -62.5 -75.7 197 200 230 170 169
6/5/2021 01:26:00 5.1 5.0 -63.0 -75.7 202 200 230 170 175
6/5/2021 01:27:00 4.9 5.0 -63.4 -75.6 197 200 230 170 170
6/5/2021 01:28:00 5.1 5.0 -63.6 -75.6 199 200 230 170 172
6/5/2021 01:29:00 4.9 5.0 -63.9 -75.6 201 200 230 170 174
6/5/2021 01:30:00 4.9 5.0 -63.6 -75.7 200 200 230 170 172
6/5/2021 01:31:00 5.1 5.0 -63.2 -75.7 200 200 230 170 173
6/5/2021 01:32:00 4.9 5.0 -62.7 -75.6 201 200 230 170 173
6/5/2021 01:33:00 5.1 5.0 -62.3 -75.6 199 200 230 170 173
6/5/2021 01:34:00 5.1 5.0 -62.3 -75.6 200 200 230 170 173
6/5/2021 01:35:00 5.0 5.0 -63.0 -75.6 200 200 230 170 173
6/5/2021 01:36:00 5.1 5.0 -63.4 -75.7 200 200 230 170 173
6/5/2021 01:37:00 4.9 5.0 -63.4 -75.6 200 200 230 170 173
6/5/2021 01:38:00 4.9 5.0 -63.1 -75.7 201 200 230 170 173
6/5/2021 01:39:00 5.1 5.0 -62.7 -75.7 201 200 230 170 173
6/5/2021 01:40:00 4.9 5.0 -62.3 -75.7 199 200 230 170 173
6/5/2021 01:41:00 5.1 5.0 -62.9 -75.7 200 200 230 170 173
6/5/2021 01:42:00 5.0 5.0 -63.4 -75.7 199 200 230 170 173
6/5/2021 01:43:00 5.1 5.0 -63.3 -75.7 200 200 230 170 173
6/5/2021 01:44:00 4.9 5.0 -62.9 -75.6 200 200 230 170 173
6/5/2021 01:45:00 5.1 5.0 -63.2 -75.6 201 200 230 170 173
6/5/2021 01:46:00 5.1 5.0 -63.5 -75.7 200 200 230 170 173
6/5/2021 01:47:00 5.0 5.0 -63.2 -75.8 200 200 230 170 173

-------------------------------------------
Approved by Date Page: 78 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 01:48:00 5.1 5.0 -62.9 -75.8 200 200 230 170 173
6/5/2021 01:49:00 4.9 5.0 -62.5 -75.8 200 200 230 170 173
6/5/2021 01:50:00 5.1 5.0 -62.1 -75.8 199 200 230 170 173
6/5/2021 01:51:00 5.1 5.0 -61.8 -75.8 199 200 230 170 173
6/5/2021 01:52:00 4.9 5.0 -61.8 -75.8 199 200 230 170 173
6/5/2021 01:53:00 5.1 5.0 -62.5 -75.8 201 200 230 170 173
6/5/2021 01:54:00 4.9 5.0 -63.1 -75.8 201 200 230 170 173
6/5/2021 01:55:00 4.9 5.0 -63.1 -75.9 201 200 230 170 173
6/5/2021 01:56:00 5.1 5.0 -62.9 -76.0 201 200 230 170 173
6/5/2021 01:57:00 5.0 5.0 -62.6 -75.9 201 200 230 170 173
6/5/2021 01:58:00 5.1 5.0 -62.1 -75.9 200 200 230 170 173
6/5/2021 01:59:00 4.9 5.0 -61.8 -75.8 199 200 230 170 173
6/5/2021 02:00:00 5.1 5.0 -61.6 -75.8 199 200 230 170 173
6/5/2021 02:01:00 5.1 5.0 -61.8 -75.9 200 200 230 170 173
6/5/2021 02:02:00 5.0 5.0 -62.5 -75.8 201 200 230 170 173
6/5/2021 02:03:00 5.1 5.0 -63.0 -75.9 200 200 230 170 173
6/5/2021 02:04:00 4.9 5.0 -63.4 -75.8 201 200 230 170 173
6/5/2021 02:05:00 5.1 5.0 -63.4 -75.8 200 200 230 170 173
6/5/2021 02:06:00 5.1 5.0 -63.0 -75.9 201 200 230 170 173
6/5/2021 02:07:00 5.0 5.0 -62.6 -75.9 199 200 230 170 173
6/5/2021 02:08:00 5.1 5.0 -62.9 -75.9 199 200 230 170 173
6/5/2021 02:09:00 5.0 5.0 -63.3 -75.9 199 200 230 170 173
6/5/2021 02:10:00 5.1 5.0 -63.5 -75.9 200 200 230 170 173
6/5/2021 02:10:10 Event: - Step advanced to [9] Drying
6/5/2021 02:11:00 5.2 5.4 -63.7 -75.9 199 200 230 170 173
6/5/2021 02:12:00 5.3 6.0 -64.1 -76.2 200 200 230 170 173
6/5/2021 02:13:00 5.8 6.4 -64.1 -76.6 200 200 230 170 173

-------------------------------------------
Approved by Date Page: 79 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 02:14:00 6.5 6.9 -63.7 -77.0 200 200 230 170 173
6/5/2021 02:15:00 7.3 7.4 -63.1 -77.5 200 200 230 170 173
6/5/2021 02:16:00 8.1 7.9 -62.6 -77.9 201 200 230 170 173
6/5/2021 02:17:00 8.7 8.4 -62.2 -78.3 200 200 230 170 173
6/5/2021 02:18:00 9.2 8.9 -61.8 -78.7 200 200 230 170 173
6/5/2021 02:19:00 9.5 9.4 -62.0 -79.0 201 200 230 170 173
6/5/2021 02:20:00 9.9 10.0 -62.4 -79.3 200 200 230 170 173
6/5/2021 02:21:00 10.3 10.4 -62.3 -79.4 200 200 230 170 173
6/5/2021 02:22:00 10.8 10.9 -62.1 -79.5 199 200 230 170 173
6/5/2021 02:23:00 11.3 11.4 -62.0 -79.6 200 200 230 170 173
6/5/2021 02:24:00 11.8 11.9 -62.3 -79.7 201 200 230 170 173
6/5/2021 02:25:00 12.4 12.4 -62.9 -79.8 200 200 230 170 173
6/5/2021 02:26:00 12.9 13.0 -63.0 -79.9 200 200 230 170 173
6/5/2021 02:27:00 13.5 13.4 -62.9 -80.0 200 200 230 170 173
6/5/2021 02:28:00 14.0 13.9 -62.6 -80.1 199 200 230 170 173
6/5/2021 02:29:00 14.5 14.4 -62.2 -80.0 200 200 230 170 173
6/5/2021 02:30:00 14.9 14.9 -62.0 -80.0 200 200 230 170 173
6/5/2021 02:31:00 15.4 15.4 -62.6 -80.1 201 200 230 170 173
6/5/2021 02:32:00 15.8 15.9 -63.1 -80.1 201 200 230 170 173
6/5/2021 02:33:00 16.4 16.4 -63.6 -80.2 201 200 230 170 173
6/5/2021 02:34:00 16.9 17.0 -63.6 -80.3 200 200 230 170 173
6/5/2021 02:35:00 17.4 17.4 -63.2 -80.2 199 200 230 170 172
6/5/2021 02:36:00 17.9 17.9 -62.9 -80.2 200 200 230 170 172
6/5/2021 02:37:00 18.5 18.4 -62.4 -80.2 199 200 230 170 172
6/5/2021 02:38:00 19.0 18.9 -62.2 -80.1 199 200 230 170 172
6/5/2021 02:39:00 19.4 19.4 -62.9 -80.0 199 200 230 170 172
6/5/2021 02:40:00 19.9 19.9 -63.7 -79.9 199 200 230 170 172

-------------------------------------------
Approved by Date Page: 80 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 02:41:00 20.4 20.4 -63.7 -79.8 200 200 230 170 172
6/5/2021 02:42:00 20.9 20.9 -63.3 -79.6 200 200 230 170 172
6/5/2021 02:43:00 21.4 21.4 -62.9 -79.5 201 200 230 170 172
6/5/2021 02:44:00 21.9 21.9 -62.6 -79.4 201 200 230 170 172
6/5/2021 02:45:00 22.4 22.4 -63.2 -79.3 201 200 230 170 172
6/5/2021 02:46:00 22.9 22.9 -63.8 -79.3 201 200 230 170 172
6/5/2021 02:47:00 23.4 23.4 -64.3 -79.4 201 200 230 170 172
6/5/2021 02:48:00 24.0 24.0 -64.1 -79.4 201 200 230 170 172
6/5/2021 02:49:00 24.4 24.4 -63.7 -79.3 201 200 230 170 172
6/5/2021 02:50:00 24.9 24.9 -63.2 -79.2 200 200 230 170 172
6/5/2021 02:51:00 25.4 25.4 -62.8 -79.2 200 200 230 170 172
6/5/2021 02:52:00 25.9 25.9 -62.3 -79.2 200 200 230 170 172
6/5/2021 02:53:00 26.4 26.4 -62.0 -79.3 200 200 230 170 173
6/5/2021 02:54:00 26.9 26.9 -62.5 -79.3 199 200 230 170 173
6/5/2021 02:55:00 27.4 27.4 -63.0 -79.3 201 200 230 170 173
6/5/2021 02:56:00 27.9 28.0 -63.5 -79.3 201 200 230 170 173
6/5/2021 02:57:00 28.4 28.4 -63.8 -79.2 200 200 230 170 173
6/5/2021 02:58:00 28.9 28.9 -63.7 -79.2 200 200 230 170 173
6/5/2021 02:59:00 29.4 29.4 -63.1 -79.2 201 200 230 170 173
6/5/2021 03:00:00 30.0 29.9 -62.6 -79.3 199 200 230 170 173
6/5/2021 03:01:00 30.5 30.4 -62.1 -79.3 199 200 230 170 174
6/5/2021 03:02:00 30.9 30.9 -61.8 -79.3 200 200 230 170 174
6/5/2021 03:03:00 31.4 31.4 -61.4 -79.3 200 200 230 170 174
6/5/2021 03:04:00 31.9 31.9 -62.0 -79.2 199 200 230 170 174
6/5/2021 03:05:00 32.4 32.4 -62.6 -79.2 199 200 230 170 174
6/5/2021 03:06:00 32.9 32.9 -62.9 -79.2 200 200 230 170 174
6/5/2021 03:07:00 33.4 33.4 -62.6 -79.2 201 200 230 170 174

-------------------------------------------
Approved by Date Page: 81 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 03:08:00 33.9 33.9 -62.3 -79.3 201 200 230 170 174
6/5/2021 03:09:00 34.4 34.4 -61.9 -79.3 200 200 230 170 173
6/5/2021 03:10:00 34.9 35.0 -61.5 -79.3 199 200 230 170 173
6/5/2021 03:11:00 35.4 35.4 -62.1 -79.2 201 200 230 170 173
6/5/2021 03:12:00 35.9 35.9 -62.8 -79.3 200 200 230 170 173
6/5/2021 03:13:00 36.5 36.4 -63.1 -79.2 200 200 230 170 173
6/5/2021 03:14:00 36.9 36.9 -63.4 -79.3 199 200 230 170 173
6/5/2021 03:15:00 37.4 37.4 -63.1 -79.4 200 200 230 170 173
6/5/2021 03:16:00 37.9 37.9 -62.5 -79.4 199 200 230 170 173
6/5/2021 03:17:00 38.4 38.4 -61.9 -79.3 200 200 230 170 173
6/5/2021 03:18:00 38.9 39.0 -61.5 -79.2 199 200 230 170 173
6/5/2021 03:19:00 39.4 39.4 -61.7 -79.2 200 200 230 170 173
6/5/2021 03:20:00 39.9 39.9 -61.9 -79.2 200 200 230 170 173
6/5/2021 03:21:00 40.4 40.4 -61.8 -79.3 200 200 230 170 173
6/5/2021 03:22:00 40.9 40.9 -61.8 -79.3 200 200 230 170 173
6/5/2021 03:23:00 41.5 41.4 -62.6 -79.2 199 200 230 170 173
6/5/2021 03:24:00 42.0 41.9 -62.8 -79.2 201 200 230 170 173
6/5/2021 03:25:00 42.5 42.4 -62.5 -79.2 200 200 230 170 173
6/5/2021 03:26:00 42.9 42.9 -62.1 -79.2 200 200 230 170 173
6/5/2021 03:27:00 43.4 43.4 -61.6 -79.2 199 200 230 170 173
6/5/2021 03:28:00 43.9 43.9 -62.1 -79.3 200 200 230 170 173
6/5/2021 03:29:00 44.4 44.4 -62.6 -79.3 200 200 230 170 173
6/5/2021 03:30:00 44.9 44.9 -62.5 -79.3 200 200 230 170 173
6/5/2021 03:31:00 45.4 45.4 -62.2 -79.2 199 200 230 170 173
6/5/2021 03:32:00 45.9 46.0 -61.8 -79.2 200 200 230 170 173
6/5/2021 03:33:00 46.5 46.4 -61.4 -79.2 200 200 230 170 173
6/5/2021 03:34:00 47.0 46.9 -61.1 -79.3 201 200 230 170 173

-------------------------------------------
Approved by Date Page: 82 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 03:35:00 47.5 47.4 -60.8 -79.3 201 200 230 170 173
6/5/2021 03:36:00 48.0 47.9 -60.7 -79.3 201 200 230 170 173
6/5/2021 03:37:00 48.4 48.4 -60.6 -79.2 201 200 230 170 173
6/5/2021 03:38:00 48.9 48.9 -60.7 -79.2 201 200 230 170 173
6/5/2021 03:39:00 49.3 49.4 -61.4 -79.2 201 200 230 170 174
6/5/2021 03:40:00 49.8 50.0 -62.1 -79.2 201 200 230 170 174
6/5/2021 03:40:10 Event: - Step advanced to [10] Drying
6/5/2021 03:41:00 50.3 50.0 -62.2 -79.3 201 200 230 170 174
6/5/2021 03:42:00 50.7 50.0 -62.0 -79.3 200 200 230 170 174
6/5/2021 03:43:00 50.7 50.0 -61.5 -79.3 200 200 230 170 174
6/5/2021 03:44:00 50.4 50.0 -61.1 -79.3 199 200 230 170 174
6/5/2021 03:45:00 50.1 50.0 -60.8 -79.2 200 200 230 170 174
6/5/2021 03:46:00 49.9 50.0 -61.0 -78.9 200 200 230 170 173
6/5/2021 03:47:00 49.8 50.0 -61.5 -78.8 200 200 230 170 173
6/5/2021 03:48:00 49.8 50.0 -62.2 -78.9 201 200 230 170 173
6/5/2021 03:49:00 49.9 50.0 -62.3 -79.1 200 200 230 170 173
6/5/2021 03:50:00 50.0 50.0 -62.0 -79.2 200 200 230 170 173
6/5/2021 03:51:00 50.1 50.0 -61.6 -79.3 201 200 230 170 173
6/5/2021 03:52:00 50.2 50.0 -61.2 -79.4 201 200 230 170 173
6/5/2021 03:53:00 50.2 50.0 -61.0 -79.5 201 200 230 170 173
6/5/2021 03:54:00 50.1 50.0 -60.7 -79.6 200 200 230 170 173
6/5/2021 03:55:00 50.0 50.0 -60.7 -79.8 200 200 230 170 173
6/5/2021 03:56:00 50.0 50.0 -61.5 -79.9 200 200 230 170 173
6/5/2021 03:57:00 49.9 50.0 -62.0 -80.0 200 200 230 170 173
6/5/2021 03:58:00 49.9 50.0 -62.0 -80.0 199 200 230 170 173
6/5/2021 03:59:00 49.9 50.0 -61.8 -80.1 200 200 230 170 173
6/5/2021 04:00:00 50.0 50.0 -61.8 -80.1 199 200 230 170 173

-------------------------------------------
Approved by Date Page: 83 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 04:01:00 50.0 50.0 -62.4 -80.2 200 200 230 170 173
6/5/2021 04:02:00 50.1 50.0 -62.7 -80.2 200 200 230 170 173
6/5/2021 04:03:00 50.1 50.0 -62.9 -80.3 200 200 230 170 173
6/5/2021 04:04:00 50.1 50.0 -63.3 -80.4 200 200 230 170 173
6/5/2021 04:05:00 50.1 50.0 -63.4 -80.4 200 200 230 170 173
6/5/2021 04:05:32 Alarm: CLOSE - Communication fail with SQL database.
6/5/2021 04:06:00 49.9 50.0 -63.1 -80.3 199 200 230 170 173
6/5/2021 04:07:00 49.9 50.0 -62.7 -80.2 199 200 230 170 173
6/5/2021 04:08:00 49.9 50.0 -63.1 -80.2 199 200 230 170 173
6/5/2021 04:09:00 49.9 50.0 -63.3 -80.3 199 200 230 170 173
6/5/2021 04:10:00 50.0 50.0 -63.6 -80.3 200 200 230 170 173
6/5/2021 04:11:00 50.0 50.0 -63.4 -80.4 200 200 230 170 173
6/5/2021 04:12:00 50.1 50.0 -63.1 -80.3 199 200 230 170 173
6/5/2021 04:13:00 50.1 50.0 -62.8 -80.2 200 200 230 170 173
6/5/2021 04:14:00 50.1 50.0 -63.6 -80.1 199 200 230 170 173
6/5/2021 04:15:00 50.0 50.0 -63.7 -80.1 201 200 230 170 173
6/5/2021 04:16:00 49.9 50.0 -63.4 -80.1 200 200 230 170 173
6/5/2021 04:17:00 49.9 50.0 -63.0 -80.1 201 200 230 170 173
6/5/2021 04:18:00 49.9 50.0 -63.2 -80.2 200 200 230 170 173
6/5/2021 04:19:00 50.0 50.0 -63.6 -80.0 200 200 230 170 173
6/5/2021 04:20:00 50.1 50.0 -63.7 -80.0 200 200 230 170 173
6/5/2021 04:21:00 50.1 50.0 -64.1 -79.9 200 200 230 170 173
6/5/2021 04:22:00 50.1 50.0 -64.0 -80.0 199 200 230 170 173
6/5/2021 04:23:00 50.1 50.0 -63.7 -80.0 200 200 230 170 173
6/5/2021 04:24:00 49.9 50.0 -63.3 -80.0 200 200 230 170 173
6/5/2021 04:25:00 49.9 50.0 -63.6 -80.1 200 200 230 170 173
6/5/2021 04:26:00 49.9 50.0 -64.0 -80.0 199 200 230 170 173

-------------------------------------------
Approved by Date Page: 84 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 04:27:00 50.0 50.0 -63.9 -79.9 201 200 230 170 173
6/5/2021 04:28:00 50.0 50.0 -63.6 -79.8 201 200 230 170 173
6/5/2021 04:29:00 50.1 50.0 -63.1 -79.8 199 200 230 170 173
6/5/2021 04:30:00 50.1 50.0 -63.6 -79.9 200 200 230 170 173
6/5/2021 04:31:00 50.1 50.0 -64.0 -79.9 201 200 230 170 173
6/5/2021 04:32:00 50.0 50.0 -64.4 -80.0 199 200 230 170 173
6/5/2021 04:33:00 49.9 50.0 -64.2 -79.9 201 200 230 170 173
6/5/2021 04:34:00 49.9 50.0 -63.7 -79.9 200 200 230 170 172
6/5/2021 04:35:00 49.9 50.0 -63.2 -79.8 200 200 230 170 172
6/5/2021 04:36:00 50.0 50.0 -64.0 -79.8 200 200 230 170 172
6/5/2021 04:37:00 50.0 50.0 -64.4 -79.9 200 200 230 170 172
6/5/2021 04:38:00 50.0 50.0 -64.2 -79.9 200 200 230 170 172
6/5/2021 04:38:21 Audit: - A_SQLCOMMFAIL ALARM is acknowledged by IDIN.
6/5/2021 04:39:00 50.1 50.0 -63.8 -79.9 199 200 230 170 172
6/5/2021 04:40:00 50.1 50.0 -63.6 -79.9 200 200 230 170 172
6/5/2021 04:41:00 50.0 50.0 -64.3 -79.8 200 200 230 170 172
6/5/2021 04:42:00 49.9 50.0 -64.6 -79.7 200 200 230 170 172
6/5/2021 04:43:00 49.9 50.0 -64.7 -79.8 201 200 230 170 172
6/5/2021 04:44:00 50.0 50.0 -64.2 -79.8 199 200 230 170 172
6/5/2021 04:45:00 50.0 50.0 -63.7 -79.9 201 200 230 170 172
6/5/2021 04:46:00 50.0 50.0 -63.7 -79.9 199 200 230 170 172
6/5/2021 04:47:00 50.0 50.0 -64.3 -79.9 200 200 230 170 172
6/5/2021 04:48:00 50.1 50.0 -64.6 -79.8 200 200 230 170 172
6/5/2021 04:49:00 50.1 50.0 -64.5 -79.8 200 200 230 170 172
6/5/2021 04:50:00 50.0 50.0 -64.2 -79.7 200 200 230 170 172
6/5/2021 04:51:00 50.0 50.0 -63.7 -79.8 200 200 230 170 172
6/5/2021 04:52:00 49.9 50.0 -64.1 -79.8 200 200 230 170 172

-------------------------------------------
Approved by Date Page: 85 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 04:53:00 49.9 50.0 -64.5 -79.9 200 200 230 170 172
6/5/2021 04:54:00 50.0 50.0 -65.0 -79.8 200 200 230 170 172
6/5/2021 04:55:00 50.0 50.0 -65.0 -79.8 199 200 230 170 172
6/5/2021 04:56:00 50.1 50.0 -64.7 -79.8 200 200 230 170 172
6/5/2021 04:57:00 50.1 50.0 -64.2 -79.8 200 200 230 170 172
6/5/2021 04:58:00 50.0 50.0 -64.1 -79.8 200 200 230 170 172
6/5/2021 04:59:00 50.0 50.0 -64.7 -79.9 200 200 230 170 172
6/5/2021 05:00:00 49.9 50.0 -65.1 -79.9 201 200 230 170 172
6/5/2021 05:01:00 49.9 50.0 -65.3 -79.9 199 200 230 170 172
6/5/2021 05:02:00 50.0 50.0 -65.5 -79.9 201 200 230 170 172
6/5/2021 05:03:00 50.0 50.0 -65.3 -79.9 199 200 230 170 172
6/5/2021 05:04:00 50.0 50.0 -64.8 -79.8 199 200 230 170 172
6/5/2021 05:05:00 50.0 50.0 -64.2 -79.9 200 200 230 170 172
6/5/2021 05:06:00 50.0 50.0 -64.9 -79.9 200 200 230 170 172
6/5/2021 05:07:00 50.0 50.0 -65.5 -79.9 200 200 230 170 172
6/5/2021 05:08:00 50.0 50.0 -65.7 -80.0 200 200 230 170 172
6/5/2021 05:09:00 50.0 50.0 -65.9 -79.9 201 200 230 170 172
6/5/2021 05:10:00 50.0 50.0 -65.6 -79.9 200 200 230 170 172
6/5/2021 05:11:00 49.9 50.0 -65.0 -79.9 199 200 230 170 172
6/5/2021 05:12:00 50.0 50.0 -64.4 -79.9 200 200 230 170 172
6/5/2021 05:13:00 50.0 50.0 -64.6 -79.9 200 200 230 170 172
6/5/2021 05:14:00 50.0 50.0 -65.2 -80.0 199 200 230 170 172
6/5/2021 05:15:00 50.0 50.0 -65.5 -80.0 199 200 230 170 172
6/5/2021 05:16:00 50.0 50.0 -65.4 -79.9 200 200 230 170 172
6/5/2021 05:17:00 50.0 50.0 -65.0 -79.9 199 200 230 170 172
6/5/2021 05:18:00 50.0 50.0 -64.5 -79.9 200 200 230 170 172
6/5/2021 05:19:00 50.0 50.0 -64.8 -79.9 201 200 230 170 172

-------------------------------------------
Approved by Date Page: 86 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 05:20:00 50.0 50.0 -65.5 -80.0 201 200 230 170 172
6/5/2021 05:21:00 50.0 50.0 -65.8 -80.0 199 200 230 170 172
6/5/2021 05:22:00 50.1 50.0 -65.8 -80.0 200 200 230 170 172
6/5/2021 05:23:00 50.0 50.0 -65.5 -80.0 201 200 230 170 172
6/5/2021 05:24:00 50.0 50.0 -65.0 -79.9 200 200 230 170 172
6/5/2021 05:25:00 50.0 50.0 -64.7 -79.9 201 200 230 170 172
6/5/2021 05:26:00 50.0 50.0 -65.4 -80.0 200 200 230 170 172
6/5/2021 05:27:00 50.0 50.0 -65.8 -80.0 200 200 230 170 172
6/5/2021 05:28:00 50.0 50.0 -66.2 -80.1 200 200 230 170 172
6/5/2021 05:29:00 50.0 50.0 -66.1 -80.1 199 200 230 170 172
6/5/2021 05:30:00 50.0 50.0 -65.6 -80.0 200 200 230 170 172
6/5/2021 05:31:00 50.0 50.0 -65.0 -80.0 200 200 230 170 172
6/5/2021 05:32:00 50.0 50.0 -65.2 -80.0 201 200 230 170 172
6/5/2021 05:33:00 50.0 50.0 -65.8 -79.9 200 200 230 170 172
6/5/2021 05:34:00 49.9 50.0 -66.0 -80.0 200 200 230 170 172
6/5/2021 05:35:00 50.0 50.0 -66.4 -80.0 201 200 230 170 172
6/5/2021 05:36:00 50.0 50.0 -66.2 -80.0 201 200 230 170 172
6/5/2021 05:37:00 50.0 50.0 -65.8 -80.0 201 200 230 170 172
6/5/2021 05:38:00 50.0 50.0 -65.3 -79.9 200 200 230 170 172
6/5/2021 05:39:00 50.0 50.0 -65.0 -79.9 200 200 230 170 172
6/5/2021 05:40:00 50.0 50.0 -65.7 -79.9 200 200 230 170 172
6/5/2021 05:41:00 50.0 50.0 -66.0 -80.0 199 200 230 170 172
6/5/2021 05:42:00 50.0 50.0 -66.3 -80.0 200 200 230 170 172
6/5/2021 05:43:00 50.1 50.0 -66.3 -80.0 200 200 230 170 172
6/5/2021 05:44:00 50.0 50.0 -65.8 -80.0 199 200 230 170 172
6/5/2021 05:45:00 50.0 50.0 -65.2 -80.0 200 200 230 170 172
6/5/2021 05:46:00 50.0 50.0 -64.6 -79.9 200 200 230 170 172

-------------------------------------------
Approved by Date Page: 87 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 05:47:00 50.0 50.0 -64.8 -79.9 200 200 230 170 172
6/5/2021 05:48:00 50.0 50.0 -65.4 -80.0 200 200 230 170 172
6/5/2021 05:49:00 50.0 50.0 -65.8 -80.0 200 200 230 170 172
6/5/2021 05:50:00 50.0 50.0 -66.0 -80.0 200 200 230 170 172
6/5/2021 05:51:00 50.0 50.0 -66.2 -80.0 200 200 230 170 172
6/5/2021 05:52:00 50.1 50.0 -65.9 -79.9 199 200 230 170 172
6/5/2021 05:53:00 50.0 50.0 -65.4 -79.9 201 200 230 170 172
6/5/2021 05:54:00 50.0 50.0 -64.8 -79.9 200 200 230 170 172
6/5/2021 05:55:00 50.0 50.0 -65.3 -79.9 200 200 230 170 172
6/5/2021 05:56:00 50.0 50.0 -66.0 -79.9 199 200 230 170 172
6/5/2021 05:57:00 50.0 50.0 -66.1 -80.0 200 200 230 170 172
6/5/2021 05:58:00 50.0 50.0 -65.6 -79.9 200 200 230 170 172
6/5/2021 05:59:00 50.0 50.0 -65.2 -79.9 200 200 230 170 172
6/5/2021 06:00:00 50.0 50.0 -65.3 -79.9 200 200 230 170 172
6/5/2021 06:01:00 50.0 50.0 -66.0 -79.9 200 200 230 170 172
6/5/2021 06:02:00 50.0 50.0 -66.5 -80.0 200 200 230 170 172
6/5/2021 06:03:00 50.0 50.0 -66.8 -80.0 200 200 230 170 172
6/5/2021 06:04:00 50.0 50.0 -66.9 -80.0 201 200 230 170 172
6/5/2021 06:05:00 50.0 50.0 -66.7 -80.0 200 200 230 170 172
6/5/2021 06:06:00 50.0 50.0 -66.9 -79.9 200 200 230 170 172
6/5/2021 06:07:00 50.0 50.0 -67.2 -79.9 200 200 230 170 172
6/5/2021 06:08:00 50.0 50.0 -67.3 -80.0 200 200 230 170 172
6/5/2021 06:09:00 50.0 50.0 -67.1 -80.0 200 200 230 170 172
6/5/2021 06:10:00 50.0 50.0 -66.4 -80.0 199 200 230 170 172
6/5/2021 06:11:00 50.0 50.0 -65.7 -80.0 199 200 230 170 172
6/5/2021 06:12:00 50.0 50.0 -65.8 -80.0 199 200 230 170 172
6/5/2021 06:13:00 50.0 50.0 -66.3 -80.0 201 200 230 170 172

-------------------------------------------
Approved by Date Page: 88 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 06:14:00 50.0 50.0 -66.7 -80.0 200 200 230 170 172
6/5/2021 06:15:00 50.0 50.0 -66.8 -80.0 199 200 230 170 172
6/5/2021 06:16:00 50.0 50.0 -67.1 -80.0 201 200 230 170 172
6/5/2021 06:17:00 50.0 50.0 -67.2 -80.1 201 200 230 170 172
6/5/2021 06:18:00 50.0 50.0 -66.7 -80.1 200 200 230 170 172
6/5/2021 06:19:00 50.0 50.0 -66.1 -80.0 199 200 230 170 172
6/5/2021 06:20:00 50.0 50.0 -65.4 -80.0 200 200 230 170 172
6/5/2021 06:21:00 50.0 50.0 -65.0 -79.9 199 200 230 170 172
6/5/2021 06:22:00 50.0 50.0 -65.7 -80.0 200 200 230 170 172
6/5/2021 06:23:00 50.0 50.0 -66.3 -80.0 200 200 230 170 172
6/5/2021 06:24:00 50.0 50.0 -66.5 -80.0 200 200 230 170 172
6/5/2021 06:25:00 50.0 50.0 -66.7 -80.0 200 200 230 170 172
6/5/2021 06:26:00 49.9 50.0 -67.0 -80.0 200 200 230 170 172
6/5/2021 06:27:00 50.0 50.0 -67.1 -80.0 200 200 230 170 172
6/5/2021 06:28:00 50.0 50.0 -66.7 -80.0 201 200 230 170 172
6/5/2021 06:29:00 50.0 50.0 -66.1 -80.0 201 200 230 170 172
6/5/2021 06:30:00 50.0 50.0 -65.6 -80.0 199 200 230 170 172
6/5/2021 06:31:00 50.0 50.0 -66.3 -80.0 200 200 230 170 172
6/5/2021 06:32:00 50.0 50.0 -66.7 -80.0 200 200 230 170 172
6/5/2021 06:33:00 50.0 50.0 -67.1 -80.0 200 200 230 170 172
6/5/2021 06:34:00 50.0 50.0 -67.1 -80.0 200 200 230 170 172
6/5/2021 06:35:00 50.0 50.0 -66.7 -80.0 200 200 230 170 172
6/5/2021 06:36:00 50.0 50.0 -66.1 -80.0 199 200 230 170 172
6/5/2021 06:37:00 50.0 50.0 -65.8 -80.0 200 200 230 170 172
6/5/2021 06:38:00 50.0 50.0 -66.6 -80.0 200 200 230 170 172
6/5/2021 06:39:00 50.0 50.0 -67.1 -80.1 200 200 230 170 172
6/5/2021 06:40:00 50.0 50.0 -67.2 -80.1 200 200 230 170 172

-------------------------------------------
Approved by Date Page: 89 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 06:41:00 50.0 50.0 -67.2 -80.0 199 200 230 170 172
6/5/2021 06:42:00 50.0 50.0 -67.4 -80.0 200 200 230 170 172
6/5/2021 06:43:00 50.0 50.0 -67.5 -80.1 200 200 230 170 172
6/5/2021 06:44:00 50.0 50.0 -67.7 -80.1 199 200 230 170 172
6/5/2021 06:45:00 50.0 50.0 -67.5 -80.1 201 200 230 170 172
6/5/2021 06:46:00 50.0 50.0 -66.9 -80.1 200 200 230 170 172
6/5/2021 06:47:00 50.0 50.0 -66.2 -80.1 200 200 230 170 172
6/5/2021 06:48:00 50.0 50.0 -65.6 -80.1 200 200 230 170 172
6/5/2021 06:49:00 50.0 50.0 -66.3 -80.0 200 200 230 170 172
6/5/2021 06:50:00 50.0 50.0 -66.9 -80.1 200 200 230 170 172
6/5/2021 06:51:00 50.0 50.0 -67.2 -80.1 200 200 230 170 172
6/5/2021 06:52:00 50.0 50.0 -66.8 -80.1 200 200 230 170 172
6/5/2021 06:53:00 50.0 50.0 -66.3 -80.1 200 200 230 170 172
6/5/2021 06:54:00 50.0 50.0 -65.7 -80.1 200 200 230 170 172
6/5/2021 06:55:00 50.0 50.0 -66.3 -80.1 200 200 230 170 172
6/5/2021 06:56:00 50.0 50.0 -66.9 -80.1 201 200 230 170 172
6/5/2021 06:57:00 50.0 50.0 -67.2 -80.1 200 200 230 170 172
6/5/2021 06:58:00 50.0 50.0 -67.4 -80.1 200 200 230 170 172
6/5/2021 06:59:00 50.0 50.0 -67.6 -80.1 199 200 230 170 172
6/5/2021 07:00:00 50.0 50.0 -67.4 -80.1 200 200 230 170 172
6/5/2021 07:01:00 50.0 50.0 -66.9 -80.1 200 200 230 170 172
6/5/2021 07:02:00 50.0 50.0 -66.4 -80.1 200 200 230 170 172
6/5/2021 07:03:00 50.0 50.0 -66.2 -80.1 200 200 230 170 172
6/5/2021 07:04:00 50.0 50.0 -66.9 -80.1 200 200 230 170 172
6/5/2021 07:05:00 50.0 50.0 -67.6 -80.1 201 200 230 170 172
6/5/2021 07:06:00 50.0 50.0 -67.7 -80.2 200 200 230 170 172
6/5/2021 07:07:00 50.0 50.0 -68.0 -80.1 200 200 230 170 172

-------------------------------------------
Approved by Date Page: 90 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 07:08:00 50.0 50.0 -67.9 -80.1 199 200 230 170 172
6/5/2021 07:09:00 50.0 50.0 -68.1 -80.1 200 200 230 170 172
6/5/2021 07:10:00 50.0 50.0 -68.2 -80.1 200 200 230 170 172
6/5/2021 07:11:00 50.0 50.0 -67.8 -80.1 199 200 230 170 172
6/5/2021 07:12:00 50.0 50.0 -67.2 -80.1 200 200 230 170 172
6/5/2021 07:13:00 50.0 50.0 -66.5 -80.1 200 200 230 170 172
6/5/2021 07:14:00 50.0 50.0 -67.0 -80.2 200 200 230 170 172
6/5/2021 07:15:00 50.0 50.0 -67.6 -80.1 199 200 230 170 172
6/5/2021 07:16:00 50.0 50.0 -67.7 -80.1 200 200 230 170 172
6/5/2021 07:17:00 50.0 50.0 -67.4 -80.1 200 200 230 170 172
6/5/2021 07:18:00 50.0 50.0 -67.4 -80.1 200 200 230 170 172
6/5/2021 07:19:00 50.0 50.0 -67.7 -80.1 200 200 230 170 172
6/5/2021 07:20:00 50.0 50.0 -67.8 -80.2 200 200 230 170 172
6/5/2021 07:21:00 50.0 50.0 -67.5 -80.2 201 200 230 170 172
6/5/2021 07:22:00 50.0 50.0 -66.8 -80.2 200 200 230 170 172
6/5/2021 07:23:00 50.0 50.0 -66.9 -80.2 200 200 230 170 172
6/5/2021 07:24:00 50.0 50.0 -67.6 -80.1 200 200 230 170 172
6/5/2021 07:25:00 50.0 50.0 -67.7 -80.2 200 200 230 170 172
6/5/2021 07:26:00 50.0 50.0 -67.7 -80.2 200 200 230 170 172
6/5/2021 07:27:00 50.0 50.0 -67.9 -80.2 199 200 230 170 172
6/5/2021 07:28:00 50.0 50.0 -68.1 -80.2 200 200 230 170 172
6/5/2021 07:29:00 50.0 50.0 -68.2 -80.2 200 200 230 170 172
6/5/2021 07:30:00 50.0 50.0 -68.2 -80.2 200 200 230 170 172
6/5/2021 07:31:00 50.0 50.0 -68.3 -80.2 200 200 230 170 172
6/5/2021 07:32:00 50.0 50.0 -68.4 -80.2 200 200 230 170 172
6/5/2021 07:33:00 50.0 50.0 -68.2 -80.2 200 200 230 170 172
6/5/2021 07:34:00 50.0 50.0 -67.6 -80.3 200 200 230 170 172

-------------------------------------------
Approved by Date Page: 91 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 07:35:00 50.0 50.0 -66.9 -80.3 200 200 230 170 172
6/5/2021 07:36:00 50.0 50.0 -67.0 -80.3 201 200 230 170 172
6/5/2021 07:37:00 50.0 50.0 -67.8 -80.3 199 200 230 170 172
6/5/2021 07:38:00 50.0 50.0 -68.4 -80.3 200 200 230 170 172
6/5/2021 07:39:00 50.0 50.0 -68.4 -80.2 200 200 230 170 172
6/5/2021 07:40:00 50.0 50.0 -68.8 -80.2 200 200 230 170 172
6/5/2021 07:41:00 50.0 50.0 -68.7 -80.2 200 200 230 170 171
6/5/2021 07:42:00 50.0 50.0 -68.8 -80.2 200 200 230 170 171
6/5/2021 07:43:00 50.0 50.0 -68.9 -80.2 200 200 230 170 171
6/5/2021 07:44:00 50.0 50.0 -69.2 -80.2 200 200 230 170 171
6/5/2021 07:45:00 50.0 50.0 -69.1 -80.2 200 200 230 170 171
6/5/2021 07:46:00 50.0 50.0 -69.0 -80.1 200 200 230 170 171
6/5/2021 07:47:00 50.0 50.0 -69.2 -80.2 200 200 230 170 171
6/5/2021 07:48:00 50.0 50.0 -68.8 -80.1 200 200 230 170 171
6/5/2021 07:49:00 50.0 50.0 -68.8 -80.1 200 200 230 170 172
6/5/2021 07:50:00 50.0 50.0 -68.6 -80.2 200 200 230 170 172
6/5/2021 07:51:00 50.0 50.0 -68.5 -80.2 200 200 230 170 172
6/5/2021 07:52:00 50.0 50.0 -68.5 -80.1 200 200 230 170 172
6/5/2021 07:53:00 50.0 50.0 -68.3 -80.1 200 200 230 170 172
6/5/2021 07:54:00 50.0 50.0 -68.3 -80.1 200 200 230 170 172
6/5/2021 07:55:00 50.0 50.0 -68.3 -80.1 200 200 230 170 172
6/5/2021 07:56:00 50.0 50.0 -68.5 -80.1 200 200 230 170 172
6/5/2021 07:57:00 50.0 50.0 -68.0 -80.1 200 200 230 170 172
6/5/2021 07:58:00 50.0 50.0 -67.1 -80.1 200 200 230 170 172
6/5/2021 07:59:00 50.0 50.0 -66.4 -80.1 200 200 230 170 172
6/5/2021 08:00:00 50.0 50.0 -65.6 -80.1 200 200 230 170 172
6/5/2021 08:01:00 50.0 50.0 -65.0 -80.1 200 200 230 170 172

-------------------------------------------
Approved by Date Page: 92 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 08:02:00 50.0 50.0 -65.3 -80.0 200 200 230 170 172
6/5/2021 08:03:00 50.0 50.0 -65.9 -80.0 200 200 230 170 172
6/5/2021 08:04:00 50.0 50.0 -66.3 -80.0 200 200 230 170 172
6/5/2021 08:05:00 50.0 50.0 -66.6 -80.0 200 200 230 170 173
6/5/2021 08:06:00 50.0 50.0 -67.0 -80.0 200 200 230 170 173
6/5/2021 08:07:00 50.0 50.0 -67.2 -80.0 200 200 230 170 173
6/5/2021 08:08:00 50.0 50.0 -67.3 -80.0 200 200 230 170 173
6/5/2021 08:09:00 50.0 50.0 -67.4 -80.1 200 200 230 170 173
6/5/2021 08:10:00 50.0 50.0 -66.9 -80.0 200 200 230 170 173
6/5/2021 08:11:00 50.0 50.0 -67.2 -80.1 200 200 230 170 173
6/5/2021 08:12:00 50.0 50.0 -66.8 -80.0 200 200 230 170 173
6/5/2021 08:13:00 50.0 50.0 -66.4 -80.0 200 200 230 170 173
6/5/2021 08:14:00 50.0 50.0 -66.5 -80.0 200 200 230 170 174
6/5/2021 08:15:00 50.0 50.0 -66.7 -80.0 200 200 230 170 173
6/5/2021 08:16:00 50.0 50.0 -66.7 -80.1 199 200 230 170 173
6/5/2021 08:17:00 50.0 50.0 -66.8 -80.1 200 200 230 170 173
6/5/2021 08:18:00 50.0 50.0 -67.0 -80.1 200 200 230 170 173
6/5/2021 08:19:00 50.0 50.0 -67.2 -80.1 200 200 230 170 174
6/5/2021 08:20:00 50.0 50.0 -67.0 -80.1 200 200 230 170 174
6/5/2021 08:21:00 50.0 50.0 -66.9 -80.2 200 200 230 170 173
6/5/2021 08:22:00 50.0 50.0 -66.3 -80.2 200 200 230 170 173
6/5/2021 08:23:00 50.0 50.0 -65.6 -80.3 201 200 230 170 173
6/5/2021 08:24:00 50.0 50.0 -65.0 -80.3 200 200 230 170 173
6/5/2021 08:25:00 50.0 50.0 -64.4 -80.3 200 200 230 170 173
6/5/2021 08:26:00 50.0 50.0 -65.0 -80.4 200 200 230 170 173
6/5/2021 08:27:00 50.0 50.0 -65.3 -80.4 200 200 230 170 173
6/5/2021 08:28:00 50.0 50.0 -65.8 -80.5 200 200 230 170 173

-------------------------------------------
Approved by Date Page: 93 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 08:29:00 50.0 50.0 -66.0 -80.5 200 200 230 170 173
6/5/2021 08:30:00 50.0 50.0 -66.2 -80.5 200 200 230 170 173
6/5/2021 08:31:00 50.0 50.0 -66.2 -80.5 200 200 230 170 173
6/5/2021 08:32:00 50.0 50.0 -66.1 -80.5 200 200 230 170 172
6/5/2021 08:33:00 50.0 50.0 -66.1 -80.4 200 200 230 170 173
6/5/2021 08:34:00 50.0 50.0 -66.1 -80.4 200 200 230 170 173
6/5/2021 08:35:00 50.0 50.0 -66.0 -80.4 200 200 230 170 173
6/5/2021 08:36:00 50.0 50.0 -66.0 -80.4 200 200 230 170 173
6/5/2021 08:37:00 50.0 50.0 -66.2 -80.4 200 200 230 170 173
6/5/2021 08:38:00 50.0 50.0 -66.2 -80.4 200 200 230 170 173
6/5/2021 08:39:00 50.0 50.0 -66.2 -80.4 200 200 230 170 173
6/5/2021 08:40:00 50.0 50.0 -66.2 -80.4 200 200 230 170 172
6/5/2021 08:41:00 50.0 50.0 -65.8 -80.4 200 200 230 170 173
6/5/2021 08:42:00 50.0 50.0 -65.2 -80.4 200 200 230 170 173
6/5/2021 08:43:00 50.0 50.0 -64.5 -80.3 200 200 230 170 173
6/5/2021 08:44:00 50.0 50.0 -63.9 -80.3 200 200 230 170 173
6/5/2021 08:45:00 50.0 50.0 -63.6 -80.3 199 200 230 170 173
6/5/2021 08:46:00 50.0 50.0 -64.2 -80.3 200 200 230 170 174
6/5/2021 08:47:00 50.0 50.0 -64.6 -80.3 200 200 230 170 173
6/5/2021 08:48:00 50.0 50.0 -65.1 -80.3 200 200 230 170 174
6/5/2021 08:49:00 50.0 50.0 -65.3 -80.2 200 200 230 170 173
6/5/2021 08:50:00 50.0 50.0 -65.5 -80.3 200 200 230 170 174
6/5/2021 08:51:00 50.0 50.0 -65.7 -80.3 200 200 230 170 174
6/5/2021 08:52:00 50.0 50.0 -65.8 -80.3 200 200 230 170 174
6/5/2021 08:53:00 50.0 50.0 -65.6 -80.3 200 200 230 170 174
6/5/2021 08:54:00 50.0 50.0 -65.7 -80.3 200 200 230 170 174
6/5/2021 08:55:00 50.0 50.0 -65.6 -80.3 200 200 230 170 174

-------------------------------------------
Approved by Date Page: 94 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 08:56:00 50.0 50.0 -65.8 -80.2 200 200 230 170 174
6/5/2021 08:57:00 50.0 50.0 -65.5 -80.3 200 200 230 170 173
6/5/2021 08:58:00 50.0 50.0 -64.8 -80.3 200 200 230 170 174
6/5/2021 08:59:00 50.0 50.0 -64.2 -80.3 200 200 230 170 174
6/5/2021 09:00:00 50.1 50.0 -63.5 -80.2 200 200 230 170 174
6/5/2021 09:01:00 50.0 50.0 -63.0 -80.2 200 200 230 170 173
6/5/2021 09:02:00 50.0 50.0 -63.0 -80.1 200 200 230 170 173
6/5/2021 09:03:00 50.0 50.0 -63.5 -80.1 200 200 230 170 173
6/5/2021 09:04:00 50.0 50.0 -64.2 -80.1 200 200 230 170 173
6/5/2021 09:05:00 50.0 50.0 -64.4 -80.1 200 200 230 170 173
6/5/2021 09:06:00 50.0 50.0 -64.0 -80.2 200 200 230 170 173
6/5/2021 09:07:00 50.0 50.0 -63.5 -80.2 200 200 230 170 173
6/5/2021 09:08:00 50.0 50.0 -63.4 -80.3 200 200 230 170 173
6/5/2021 09:09:00 50.0 50.0 -64.1 -80.3 200 200 230 170 173
6/5/2021 09:10:00 50.0 50.0 -64.2 -80.4 200 200 230 170 173
6/5/2021 09:11:00 50.0 50.0 -64.4 -80.5 200 200 230 170 173
6/5/2021 09:12:00 50.0 50.0 -64.8 -80.6 200 200 230 170 173
6/5/2021 09:13:00 50.0 50.0 -64.8 -80.6 200 200 230 170 173
6/5/2021 09:14:00 50.0 50.0 -64.4 -80.6 200 200 230 170 173
6/5/2021 09:15:00 50.0 50.0 -63.9 -80.6 200 200 230 170 173
6/5/2021 09:16:00 50.0 50.0 -63.9 -80.6 200 200 230 170 173
6/5/2021 09:17:00 50.0 50.0 -64.7 -80.6 200 200 230 170 173
6/5/2021 09:18:00 50.0 50.0 -65.1 -80.6 200 200 230 170 173
6/5/2021 09:19:00 50.0 50.0 -65.4 -80.7 200 200 230 170 173
6/5/2021 09:20:00 50.0 50.0 -65.6 -80.8 200 200 230 170 173
6/5/2021 09:21:00 50.0 50.0 -65.6 -80.8 200 200 230 170 173
6/5/2021 09:22:00 50.0 50.0 -65.7 -80.9 200 200 230 170 173

-------------------------------------------
Approved by Date Page: 95 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 09:23:00 50.0 50.0 -66.0 -80.9 200 200 230 170 173
6/5/2021 09:24:00 50.0 50.0 -66.0 -80.9 199 200 230 170 173
6/5/2021 09:25:00 50.0 50.0 -65.5 -80.9 200 200 230 170 173
6/5/2021 09:26:00 50.0 50.0 -65.0 -80.8 200 200 230 170 172
6/5/2021 09:27:00 50.0 50.0 -64.5 -80.8 200 200 230 170 173
6/5/2021 09:28:00 50.0 50.0 -65.3 -80.8 200 200 230 170 173
6/5/2021 09:29:00 50.0 50.0 -65.8 -80.8 200 200 230 170 173
6/5/2021 09:30:00 50.0 50.0 -66.0 -80.8 200 200 230 170 173
6/5/2021 09:31:00 50.0 50.0 -66.1 -80.7 199 200 230 170 172
6/5/2021 09:32:00 50.0 50.0 -66.4 -80.7 200 200 230 170 173
6/5/2021 09:33:00 50.0 50.0 -66.3 -80.7 200 200 230 170 173
6/5/2021 09:34:00 50.0 50.0 -66.2 -80.7 200 200 230 170 172
6/5/2021 09:35:00 50.0 50.0 -66.5 -80.7 200 200 230 170 172
6/5/2021 09:36:00 50.0 50.0 -66.7 -80.7 200 200 230 170 173
6/5/2021 09:37:00 50.0 50.0 -66.7 -80.7 200 200 230 170 173
6/5/2021 09:38:00 50.0 50.0 -66.3 -80.7 200 200 230 170 173
6/5/2021 09:39:00 50.0 50.0 -66.8 -80.7 200 200 230 170 173
6/5/2021 09:40:00 50.0 50.0 -67.0 -80.7 200 200 230 170 173
6/5/2021 09:40:10 Event: - Step advanced to [11] Moisture Test
6/5/2021 09:40:15 Event: - The pressure rise test is started.
6/5/2021 09:41:00 50.0 50.0 -66.8 -80.7 177 200 230 170 7
6/5/2021 09:41:30 Event: - Pressure rise test passed.Pressure rise test setpoint value is [10µBar] Pressure rise test setpoint time is
[60Sec.] The final chamber vacuum rise in this test is [2µBar] Pressure rise test process time is [60Sec.]
Event: - Step advanced to [12] Pre-aeration
6/5/2021 09:42:00 50.0 50.0 -66.3 -80.8 - - 230 170 5
6/5/2021 09:43:00 50.0 50.0 -66.3 -81.0 - - 230 170 5
6/5/2021 09:44:00 50.0 50.0 -66.6 -81.3 - - 230 170 4

-------------------------------------------
Approved by Date Page: 96 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 09:45:00 50.0 50.0 -66.9 -81.6 - - 230 170 4
6/5/2021 09:46:00 50.0 50.0 -67.6 -82.1 - - 230 170 3
6/5/2021 09:47:00 49.9 50.0 -68.2 -82.3 - - 230 170 3
6/5/2021 09:48:00 49.9 50.0 -68.9 -82.3 - - 230 170 3
Event: - Step advanced to [13] Stoppering
6/5/2021 09:49:00 49.9 50.0 -69.4 -82.0 - - 230 170 3
6/5/2021 09:50:00 50.0 50.0 -69.7 -81.8 - - 230 170 3
6/5/2021 09:51:00 49.9 50.0 -69.8 -81.7 - - 230 170 3
6/5/2021 09:51:05 Event: - Step advanced to [14] Aeration
6/5/2021 09:52:00 50.0 50.0 -69.8 -81.6 - - 230 170 3
6/5/2021 09:53:00 50.0 50.0 -69.8 -81.4 - - 230 170 3
6/5/2021 09:54:00 50.1 50.0 -69.8 -81.3 - - 230 170 3
6/5/2021 09:55:00 50.1 50.0 -69.9 -81.1 - - 230 170 3
6/5/2021 09:56:00 50.1 50.0 -69.9 -81.0 - - 230 170 3
6/5/2021 09:57:00 50.0 50.0 -70.0 -80.8 - - 230 170 2
6/5/2021 09:58:00 50.0 50.0 -69.8 -80.7 - - 230 170 2
6/5/2021 09:59:00 49.9 50.0 -69.1 -80.4 - - 230 170 2
6/5/2021 10:00:00 49.9 50.0 -67.7 -79.2 - - 230 170 2
6/5/2021 10:01:00 49.9 50.0 -66.7 -77.5 - - 230 170 2
6/5/2021 10:02:00 50.0 50.0 -65.8 -75.4 - - 230 170 2
6/5/2021 10:03:00 50.0 50.0 -64.9 -73.6 - - 230 170 2
6/5/2021 10:04:00 50.0 50.0 -63.9 -71.8 - - 230 170 2
6/5/2021 10:05:00 50.1 50.0 -62.6 -69.4 - - 230 170 2
6/5/2021 10:06:00 50.1 50.0 -61.6 -67.1 - - 230 170 1
6/5/2021 10:07:00 50.0 50.0 -60.3 -65.5 - - 230 170 1
6/5/2021 10:08:00 50.0 50.0 -59.2 -63.9 - - 230 170 1
6/5/2021 10:09:00 49.9 50.0 -58.3 -62.6 - - 230 170 1

-------------------------------------------
Approved by Date Page: 97 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 10:10:00 49.9 50.0 -57.3 -61.3 - - 230 170 28
6/5/2021 10:11:00 50.0 50.0 -56.3 -60.2 - - 230 170 32
6/5/2021 10:12:00 50.0 50.0 -55.4 -59.0 - - 230 170 35
6/5/2021 10:13:00 50.0 50.0 -54.5 -57.9 - - 230 170 37
6/5/2021 10:13:20 Event: - Step advanced to [15] Storage
6/5/2021 10:14:00 44.4 20.0 -53.0 -57.0 - - 230 170 40
6/5/2021 10:15:00 42.3 20.0 -48.8 -56.0 - - 230 170 43
6/5/2021 10:16:00 39.2 20.0 -45.6 -55.0 - - 230 170 45
6/5/2021 10:17:00 36.1 20.0 -43.5 -54.1 - - 230 170 47
6/5/2021 10:18:00 31.9 20.0 -43.3 -53.1 - - 230 170 50
6/5/2021 10:19:00 28.6 20.0 -43.6 -52.3 - - 230 170 52
6/5/2021 10:20:00 25.5 20.0 -43.7 -51.4 - - 230 170 55
6/5/2021 10:21:00 22.4 20.0 -43.6 -50.6 - - 230 170 57
6/5/2021 10:22:00 19.4 20.0 -43.3 -49.9 - - 230 170 59
6/5/2021 10:23:00 19.1 20.0 -43.0 -49.1 - - 230 170 62
6/5/2021 10:24:00 18.1 20.0 -42.8 -48.4 - - 230 170 64
6/5/2021 10:25:00 19.5 20.0 -42.6 -47.9 - - 230 170 66
6/5/2021 10:26:00 19.6 20.0 -42.4 -47.3 - - 230 170 68
6/5/2021 10:27:00 20.4 20.0 -42.3 -46.8 - - 230 170 71
6/5/2021 10:28:00 19.8 20.0 -42.1 -46.3 - - 230 170 73
6/5/2021 10:29:00 20.4 20.0 -42.0 -45.8 - - 230 170 75
6/5/2021 10:30:00 19.8 20.0 -41.8 -45.3 - - 230 170 78
6/5/2021 10:31:00 20.5 20.0 -41.6 -44.8 - - 230 170 80
6/5/2021 10:32:00 19.6 20.0 -41.4 -44.4 - - 230 170 82
6/5/2021 10:33:00 20.4 20.0 -41.2 -44.0 - - 230 170 85
6/5/2021 10:34:00 19.9 20.0 -40.9 -43.5 - - 230 170 87
6/5/2021 10:35:00 20.4 20.0 -40.7 -43.1 - - 230 170 89

-------------------------------------------
Approved by Date Page: 98 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
6/5/2021 10:36:00 19.7 20.0 -40.5 -42.7 - - 230 170 91
6/5/2021 10:37:00 20.3 20.0 -40.2 -42.3 - - 230 170 94
6/5/2021 10:38:00 19.8 20.0 -39.9 -41.9 - - 230 170 96
6/5/2021 10:38:11 Audit: - The freeze drying cycle is advanced to the next step by IDIN.
Event: - Auto freeze drying advanced to next step.
6/5/2021 10:38:15 20.3 20.0 -39.9 -41.9 - - 230 170 98
Event: - Auto freeze drying cycle ended.

-------------------------------------------
Approved by Date Page: 99 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section4:History trend
4-1 AFD-1
Chamber vacuum Chamber vacuum PT102 Control vacuum setpoint Shelf inlet temperature
Shelf outlet temperature Shelf control temperature Condenser coil1 temperature Condenser coil2 temperature
1000 200

900

150
800

700
100

600
µBar

C
500 50

400

0
300

200
-50

100

0 -100
6/3/2021 6/3/2021 6/4/2021 6/4/2021 6/4/2021 6/4/2021 6/4/2021 6/4/2021 6/5/2021 6/5/2021
16:10 20:30 0:45 5:00 9:15 13:30 17:45 22:00 2:15 6:30
Date/Time(M/D/YYYY HH:MM:SS)

-------------------------------------------
Approved by Date Page: 100 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section4:History trend
4-2 AFD-2
Product temperature TE101 Product temperature TE102 Product temperature TE103
Product temperature TE104 Product temperature TE105
200

150

100
C

50

-50

-100
6/3/2021 6/3/2021 6/4/2021 6/4/2021 6/4/2021 6/4/2021 6/4/2021 6/4/2021 6/5/2021 6/5/2021
16:10:00 20:30:00 00:45:00 05:00:00 09:15:00 13:30:00 17:45:00 22:00:00 02:15:00 06:30:00
Date/Time(M/D/YYYY HH:MM:SS)

-------------------------------------------
Approved by Date Page: 101 of 102
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20210603161402 Batch Series Number 1856
Batch Start Time 6/3/2021 16:14:02 Batch End Time 6/5/2021 10:38:15
Initiator Full Name SAHIDIN Abortor Full Name

Section4:History trend
4-3 AFD-3
Product temperature TE106 Product temperature TE107 Product temperature TE108
Product temperature TE109 Product temperature TE110
200

150

100
C

50

-50

-100
6/3/2021 6/3/2021 6/4/2021 6/4/2021 6/4/2021 6/4/2021 6/4/2021 6/4/2021 6/5/2021 6/5/2021
16:10:00 20:30:00 00:45:00 05:00:00 09:15:00 13:30:00 17:45:00 22:00:00 02:15:00 06:30:00
Date/Time(M/D/YYYY HH:MM:SS)

-------------------------------------------
Approved by Date Page: 102 of 102

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