BINHDINH PHARMACEUTICAL AND MEDICAL EQUIPMENT JOINT STOCK COMPANY

BIDIPHAR PREPARATION SYSTEM

INTERGRITY TEST

BATCH INFORMATION BATCH INFORMATION

Product Name： Biluracil 1G Recipe Name： PY150it2
Batch Number: 1000BIL22008it2 Start Time: 2022-07-06 09:27:08
Mfd.Date: 06.07.2022 End Time: 2022-07-06 10:03:15
Exp.Date: N/a Duration: 0Day0h36m7s
Object Name： 35L&150L Filter 103F202
Result(1=Success,0=Fail) 1
Operator: Production Supervisor:

Batch Record/QA Officer:

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Recipe
WFI temperature(℃) WFI Weight in tank(kg) Wet time(s) Drain time(s)
25. 00 30. 00 300 120
Dry time(s) Minimum bubble point (mBar)
120 3200

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Event Message
Date Time Message text
1 2022-07-06 09:27:15 Wait chiller ready
2 2022-07-06 09:27:19 WFI Cooling
3 2022-07-06 09:27:54 Tank water
4 2022-07-06 09:28:42 Heat exchanger purge
5 2022-07-06 09:29:43 Heat exchanger pressure relief
6 2022-07-06 09:29:59 Tank pressurize
7 2022-07-06 09:30:08 Water collection tank
8 2022-07-06 09:35:04 Filter wetting
9 2022-07-06 09:40:03 Empty the water in the tank
10 2022-07-06 09:41:20 Tank pressure relief
11 2022-07-06 09:41:43 Water collection tank drain
12 2022-07-06 09:42:13 pressure relief
13 2022-07-06 09:42:28 Wait communicate normally
14 2022-07-06 09:42:31 Integrity test parameter assignment
15 2022-07-06 09:42:35 Waiting for test result
16 2022-07-06 09:55:09 Judge whether it is qualified
17 2022-07-06 09:55:12 Pressure emptying
18 2022-07-06 09:57:12 Air pressure drying
19 2022-07-06 09:59:12 Air pressure drying 103F201
20 2022-07-06 10:01:12 Confim to drain water by manual
21 2022-07-06 10:03:12 pressure relief

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Alarm Record
Date Time Message text

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Audit Trail
WindowsUser ComputerName TargetName OldValue NewValue Reason
2022-07-06 09:55:31 SYSTEM OS02 PY_150LHoldTank_CIPR_speed 0 60
2022-07-06 09:55:31 SYSTEM OS02 PY_150LHoldTank_CIPS_speed 0 70
2022-07-06 09:55:31 SYSTEM OS02 PY_150LHoldTank_select 0 1
2022-07-06 09:55:31 SYSTEM OS02 PY_150LHoldTank_time1 0 300
2022-07-06 09:55:31 SYSTEM OS02 PY_150LHoldTank_time2 0 60
2022-07-06 09:55:31 SYSTEM OS02 PY_150LPrepTank_CIPR_speed 60 0
2022-07-06 09:55:31 SYSTEM OS02 PY_150LPrepTank_CIPS_speed 70 0
2022-07-06 09:55:31 SYSTEM OS02 PY_150LPrepTank_select 1 0
2022-07-06 09:55:31 SYSTEM OS02 PY_150LPrepTank_time1 60 0
2022-07-06 09:55:31 SYSTEM OS02 PY_150LPrepTankLine_CIPS_speed 65 0
2022-07-06 09:55:31 SYSTEM OS02 PY_150LPrepTankLine_select 1 0
2022-07-06 09:55:31 SYSTEM OS02 PY_150LPrepTankLine_time1 300 0
2022-07-06 09:55:32 SYSTEM OS02 PY_CIP_RecipeName PY150cip3 PY150Acip4a
2022-07-06 09:55:32 SYSTEM OS02 PY_CleanType1 4 1
2022-07-06 09:55:32 SYSTEM OS02 PY_CleanType2 0 5
2022-07-06 09:55:32 SYSTEM OS02 PY_PW_highlevel 0 40
2022-07-06 09:55:32 SYSTEM OS02 PY_PW_highlevelwater 0 30
2022-07-06 09:55:32 SYSTEM OS02 PY_PW_lowlevel 0 10
2022-07-06 09:55:32 SYSTEM OS02 PY_PW_lowlevelwater 0 15
2022-07-06 09:55:32 SYSTEM OS02 PY_WFI_highlevel 40 0
2022-07-06 09:55:32 SYSTEM OS02 PY_WFI_highlevelwater 30 0
2022-07-06 09:55:32 SYSTEM OS02 PY_WFI_lowlevel 10 0
2022-07-06 09:55:32 SYSTEM OS02 PY_WFI_lowlevelwater 20 0
2022-07-06 09:55:32 SYSTEM OS02 PY_WFI_qualifycond 1 0
2022-07-06 09:55:43 SYSTEM OS02 PY_150LHoldTank_CIPR_speed 60 0
2022-07-06 09:55:43 SYSTEM OS02 PY_150LHoldTank_CIPS_speed 70 0
2022-07-06 09:55:43 SYSTEM OS02 PY_150LHoldTank_select 1 0

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WindowsUser ComputerName TargetName OldValue NewValue Reason

2022-07-06 09:55:43 SYSTEM OS02 PY_150LHoldTank_time1 300 0
2022-07-06 09:55:43 SYSTEM OS02 PY_150LHoldTank_time2 60 0
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTank_CIPR_speed 0 60
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTank_CIPS_speed 0 70
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTank_select 0 1
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTank_time1 0 300
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTank_time2 0 300
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTank_time3 0 300
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTank_time4 0 60
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTankLine_CIPS_speed 0 65
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTankLine_select 0 1
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTankLine_time1 0 300
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTankLine_time2 0 300
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTankLine_time3 0 300
2022-07-06 09:55:43 SYSTEM OS02 PY_150LPrepTankLine_time4 0 60
2022-07-06 09:55:44 SYSTEM OS02 PY_CIP_RecipeName PY150Acip4a PY150Acip4
2022-07-06 09:55:44 SYSTEM OS02 PY_CleanType2 5 1
2022-07-06 09:55:44 SYSTEM OS02 PY_CleanType3 0 4
2022-07-06 09:55:44 SYSTEM OS02 PY_CleanType4 0 5
2022-07-06 09:55:44 SYSTEM OS02 PY_PW_highlevel 40 50
2022-07-06 09:55:44 SYSTEM OS02 PY_WFI_highlevel 0 50
2022-07-06 09:55:44 SYSTEM OS02 PY_WFI_highlevelwater 0 30
2022-07-06 09:55:44 SYSTEM OS02 PY_WFI_lowlevel 0 10
2022-07-06 09:55:44 SYSTEM OS02 PY_WFI_lowlevelwater 0 20
2022-07-06 09:55:44 SYSTEM OS02 PY_WFI_qualifycond 0 1

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Data Table
103A701 Test Flow(ul/min):Integrity test actual Flow PT103A202(bar):Filter 103F202 front pressure
DateTime 103A701 Test Flow(ul/min) PT103A202
1 2022-07-06 09:27:00 3750000 -0.03
2 2022-07-06 09:28:00 3750000 -0.06
3 2022-07-06 09:29:00 3750000 -0.08
4 2022-07-06 09:30:00 3750000 -0.09
5 2022-07-06 09:31:00 3750000 0.80
6 2022-07-06 09:32:00 3750000 0.78
7 2022-07-06 09:33:00 3750000 0.78
8 2022-07-06 09:34:00 3750000 0.77
9 2022-07-06 09:35:00 3750000 0.77
10 2022-07-06 09:36:00 3750000 1.37
11 2022-07-06 09:37:00 3750000 1.38
12 2022-07-06 09:38:00 3750000 1.38
13 2022-07-06 09:39:00 3750000 1.38
14 2022-07-06 09:40:00 3750000 1.38
15 2022-07-06 09:41:00 3750000 3.62
16 2022-07-06 09:42:00 3750000 1.06
17 2022-07-06 09:43:00 0 0.68
18 2022-07-06 09:44:00 0 0.69
19 2022-07-06 09:45:00 699709 0.69
20 2022-07-06 09:46:00 734108 0.74
21 2022-07-06 09:47:00 837000 0.90
22 2022-07-06 09:48:00 1345065 1.49
23 2022-07-06 09:49:00 2203460 2.28
24 2022-07-06 09:50:00 2609633 2.65
25 2022-07-06 09:51:00 2922361 2.95
26 2022-07-06 09:52:00 3220474 3.25
27 2022-07-06 09:53:00 3468038 3.49
28 2022-07-06 09:54:00 3759938 3.77
29 2022-07-06 09:55:00 3800000 0.25
30 2022-07-06 09:56:00 3800000 2.06
31 2022-07-06 09:57:00 3800000 2.06

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DateTime 103A701 Test Flow(ul/min) PT103A202

32 2022-07-06 09:58:00 3800000 1.60
33 2022-07-06 09:59:00 3800000 1.49
34 2022-07-06 10:00:00 3800000 -0.01
35 2022-07-06 10:01:00 3800000 -0.01
36 2022-07-06 10:02:00 3800000 2.36
37 2022-07-06 10:03:00 3800000 2.35

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Data Trend

Actual Test Flow PT103A202

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