De Lama S.p.A.

Sterilisasi akhir 0.cyc_20231006124734

MASTER 6 -- Rel 7.2.3

Operator Signature :

File Name : REPC3905560054ID.rpt

PT KIMIA FARMA (Persero) Tbk

JL. Rawa Gelam V No. 1 Pulo Gadung
Sterilizer code : 4329

Cycle name : Sterilisasi akhir 0.cyc

Lot 1 : trial
Code 1 : dopamin 10 ml
Note 1 :
Cycle : 514

Start cycle executed by :DeLama user

START CYCLE 06/10/2023-12:47:33
Cycle Result : Cycle End OK
END CYCLE 06/10/2023-14:56:15

Cycle Accept :
Start verify 06/10/2023-14:56:15
Cycle accepted by operator DeLama user
Cycle comment
End verify 06/10/2023-14:56:51

General parameters description :

PID Parameters :
Num Prop. Der. Int. Opt.
1 1000.00 4.00 0.50 1.00
2 0.00 0.00 0.00 0.00
3 0.00 0.00 0.00 0.00

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 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

Letality Factor Parameters :

Letality Factor not active
Letality Factor : 0
Start Temperature Calculation : 100.10
Reference Temperature : 121.10
Coefficient Z : 10.00

Cycle Information :
Cycle Version : 1.0.0
Modified by : DeLama user 21/03/2023 - 08:42:05
Approved by : DeLama user 21/03/2023 - 08:42:58

Step by step cycle description

-------------------------------------------------------------------------------
1 - Cycle Preset
Phase : 3 "GO" pushbutton wait
Phase : 5 Jacket heating
2 - Vacuum
Phase : 7 Chamber vacuum
Phase : 9 Chamber pre-heating
Phase : 7 Chamber vacuum
Phase : 9 Chamber pre-heating
Phase : 7 Chamber vacuum
3 - Heating
Phase : 6 Chamber heating
Phase : 29 Heating holding
4 - Sterilization
Phase : 13 Sterilization
5 - Drying
Phase : 21 Chamber vacuum to set-point
Phase : 23 Chamber vacuum holding
6 - 1st Cooling with air
Phase : 1 Chamber pressurize
Phase : 17 Chamber press. holding with compres.air
7 - Cooling
Phase : 26 Cooling (with shower)
Phase : 60 Back pressure
8 - Chamber drain
Phase : 40 Chamber water drain
9 - 1st Dry
Phase : 11 Duration vacuum & steam injection
Phase : 20 Atm pressure balance 2
Repeat '9 - 1st Dry' for 1 Time(s)
10 - 2nd Dry
Phase : 38 Drying vacuum pulses
Phase : 15 Jacket heating 2
11 - Jacket drain
Phase : 33 Jacket steam drain
Phase : 1 Chamber pressurize
12 - 2nd Cooling
Phase : 18 Chamber cooling
Phase : 60 Back pressure
13 - Drain
Phase : 24 Chamber drain
14 - Cycle verify

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 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

Phase : 16 Cycle verify

-------------------------------------------------------------------------------
Cycle Parameters
Set-Point Duration Timeout Min Max
1 - Cycle Preset
Phase : 3
0.000 0=OKS 1=OKN 2=N 3=S 0.000 1= Open Auto Door
Phase : 5 119.000 °C 0.500 0.500 Rel
0.000 1 = Auto 2do "GO"
2 - Vacuum
Phase : 7 0.080 bar 8 min
5000.000 mbar Minute
Phase : 9 1.200 bar 30 min
5000.000 mbar Minute 100.000 % Max Open PID
Phase : 7 0.130 bar 60 min
5000.000 mbar Minute
Phase : 9 1.200 bar 30 min
5000.000 mbar Minute 100.000 % Max Open PID
Phase : 7 0.130 bar 60 min
5000.000 mbar Minute
3 - Heating
Phase : 6 121.500 °C 15 min 0.400 3.000 Rel
5000.000 mbar Minute 100.000 % Max Open PID
Phase : 29 121.500 °C 60 sec 4.000 4.000 Rel
5000.000 mbar Minute
4 - Sterilization
Phase : 13 121.500 °C 20 min 60 min 0.500 1.000 Rel
5000.000 mbar Minute
5 - Drying
Phase : 21 0.200 bar 40 min
5000.000 mbar Minute
Phase : 23 0.200 bar 5 min 0.010 0.050 Rel
6 - 1st Cooling with air
Phase : 1 0.200 bar 10 min 0.050 0.050 Rel
121.000 °C Temp. Steriliz. 1.000 1=Advan.S.P.to Reach 9000.000 mbar Minute
Phase : 17 0.200 bar 2 min 0.100 0.100 Rel
121.000 °C Temp steriliz.
7 - Cooling
Phase : 26 65.000 °C 0 min 60 min
Phase : 60 0.200 bar 0.030 0.030 Rel
121.000 °C Ster. Temp.
8 - Chamber drain
Phase : 40 1.200 bar 20 min
1.400 bar Cmp Air 0.100 bar Min 0.100 bar Max
9 - 1st Dry
Phase : 11 0.200 bar 5 min 0.010 0.050 Rel
100.000 °C Max Temperature 15.000 % Max Open steam
Phase : 20 1.000 bar 1 min 8 min
10 - 2nd Dry
Phase : 38 30 min 0.200 0.900 Abs
0.000 1=Heat air (PRA ON) 0.000 °C Max Temp.Chamber 5000.000 mbar Minute
Phase : 15 119.000 °C 0.500 0.500 Rel
11 - Jacket drain
Phase : 33 4 min
Phase : 1 0.100 bar 20 min 0.050 0.050 Rel
115.000 °C Temp. Steriliz. 9000.000 mbar Minute
12 - 2nd Cooling

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 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

Phase : 18 65.000 °C 30 min

Phase : 60 0.100 bar 0.030 0.030 Rel
115.000 °C Ster. Temp.
13 - Drain
Phase : 24 1.000 bar 15 min
5000.000 mbar Minute
14 - Cycle verify
Phase : 16
2.000 0=A. 1=A.No Al.2=M.
-------------------------------------------------------------------------------

Probes Excluded :

PT-W1

TE-F1

TE-W1

TE-W2

TE-W3
Alarms summary :
Cycle completed with NO ALARMS
Executed Phases :
Phase start : [5] Jacket heating 06/10/2023-12:47:33
Phase start : [7] Chamber vacuum 06/10/2023-12:47:33
Phase end : [7] 06/10/2023-12:50:16
PLC Duration Phase [7] Chamber vacuum : 2:43
Phase start : [9] Chamber pre-heating 06/10/2023-12:50:16
Phase end : [9] 06/10/2023-12:51:30
PLC Duration Phase [9] Chamber pre-heating : 1:14
Phase start : [7] Chamber vacuum 06/10/2023-12:51:30
Phase end : [7] 06/10/2023-13:01:45
PLC Duration Phase [7] Chamber vacuum : 10:15
Phase start : [9] Chamber pre-heating 06/10/2023-13:01:45
Phase end : [9] 06/10/2023-13:03:10
PLC Duration Phase [9] Chamber pre-heating : 1:25
Phase start : [7] Chamber vacuum 06/10/2023-13:03:10
Phase end : [7] 06/10/2023-13:13:03
PLC Duration Phase [7] Chamber vacuum : 9:53
Phase start : [6] Chamber heating 06/10/2023-13:13:03
Phase end : [6] 06/10/2023-13:15:28
PLC Duration Phase [6] Chamber heating : 2:25
Phase start : [29] Heating holding 06/10/2023-13:15:28
Phase end : [29] 06/10/2023-13:16:28
PLC Duration Phase [29] Heating holding : 1:00
Phase start : [13] Sterilization 06/10/2023-13:16:28
Phase end : [13] 06/10/2023-13:36:28
PLC Duration Phase [13] Sterilization : 20:00
Phase start : [21] Chamber vacuum to set-point 06/10/2023-13:36:28
Phase end : [21] 06/10/2023-13:46:35

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 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

PLC Duration Phase [21] Chamber vacuum to set-point : 10:07

Phase start : [23] Chamber vacuum holding 06/10/2023-13:46:35
Phase end : [23] 06/10/2023-13:51:35
PLC Duration Phase [23] Chamber vacuum holding : 5:00
Phase end : [5] 06/10/2023-13:51:35
PLC Duration Phase [5] Jacket heating : 64:02
Phase start : [1] Chamber pressurize 06/10/2023-13:51:35
Phase end : [1] 06/10/2023-13:52:12
PLC Duration Phase [1] Chamber pressurize : 0:36
Phase start : [17] Chamber press. holding with compres.air 06/10/2023-13:52:12
Phase end : [17] 06/10/2023-13:54:11
PLC Duration Phase [17] Chamber press. holding with compres.air : 2:00
Phase start : [26] Cooling (with shower) 06/10/2023-13:54:11
Phase start : [60] Back pressure 06/10/2023-13:54:11
Phase end : [26] 06/10/2023-14:02:34
PLC Duration Phase [26] Cooling (with shower) : 8:23
Phase end : [60] 06/10/2023-14:02:34
PLC Duration Phase [60] Back pressure : 8:23
Phase start : [40] Chamber water drain 06/10/2023-14:02:34
Phase end : [40] 06/10/2023-14:05:43
PLC Duration Phase [40] Chamber water drain : 3:08
Phase start : [11] Duration vacuum & steam injection 06/10/2023-14:05:43
Phase end : [11] 06/10/2023-14:10:42
PLC Duration Phase [11] Duration vacuum & steam injection : 5:00
Phase start : [20] Atm pressure balance 2 06/10/2023-14:10:42
Phase end : [20] 06/10/2023-14:12:21
PLC Duration Phase [20] Atm pressure balance 2 : 1:39
Phase start : [11] Duration vacuum & steam injection 06/10/2023-14:12:21
Phase end : [11] 06/10/2023-14:17:21
PLC Duration Phase [11] Duration vacuum & steam injection : 5:00
Phase start : [20] Atm pressure balance 2 06/10/2023-14:17:21
Phase end : [20] 06/10/2023-14:19:00
PLC Duration Phase [20] Atm pressure balance 2 : 1:39
Phase start : [38] Drying vacuum pulses 06/10/2023-14:19:00
Phase start : [15] Jacket heating 2 06/10/2023-14:19:00
Phase end : [38] 06/10/2023-14:49:00
PLC Duration Phase [38] Drying vacuum pulses : 30:00
Phase end : [15] 06/10/2023-14:49:00
PLC Duration Phase [15] Jacket heating 2 : 30:00
Phase start : [33] Jacket steam drain 06/10/2023-14:49:00
Phase start : [1] Chamber pressurize 06/10/2023-14:49:00
Phase end : [33] 06/10/2023-14:53:00
PLC Duration Phase [33] Jacket steam drain : 4:00
Phase end : [1] 06/10/2023-14:53:00
PLC Duration Phase [1] Chamber pressurize : 4:00
Phase start : [18] Chamber cooling 06/10/2023-14:53:00
Phase start : [60] Back pressure 06/10/2023-14:53:00
Phase end : [18] 06/10/2023-14:53:34
PLC Duration Phase [18] Chamber cooling : 0:34
Phase end : [60] 06/10/2023-14:53:34
PLC Duration Phase [60] Back pressure : 0:34
Phase start : [24] Chamber drain 06/10/2023-14:53:34
Phase end : [24] 06/10/2023-14:56:14
PLC Duration Phase [24] Chamber drain : 2:40
Phase start : [16] Cycle verify 06/10/2023-14:56:14

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 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

Phase end : [16] 06/10/2023-14:56:50

PLC Duration Phase [16] Cycle verify : 0:36

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 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

Probe Samples :

Phase start : [5] Jacket heating 06/10/2023-12:47:33

Phase start : [7] Chamber vacuum 06/10/2023-12:47:33
Time PT-01 TE-01 TE-02 TE-I
0:02 0.987 34.1 53.1 119.6
0.000 0.0 0.0 0.0
1:00 0.307 56.9 53.0 120.0
0.000 0.0 0.0 0.0
2:00 0.120 61.4 52.8 119.0
0.000 0.0 0.0 0.0
Phase end : [7] 06/10/2023-12:50:16
PLC Duration Phase [7] Chamber vacuum : 2:43
Phase start : [9] Chamber pre-heating 06/10/2023-12:50:16
Time PT-01 TE-01 TE-02 TE-I
2:43 0.080 63.0 52.7 119.0
0.000 0.0 0.0 0.0
3:00 0.567 76.6 71.5 119.4
0.000 0.0 0.0 0.0
Phase end : [9] 06/10/2023-12:51:30
PLC Duration Phase [9] Chamber pre-heating : 1:14
Phase start : [7] Chamber vacuum 06/10/2023-12:51:30
Time PT-01 TE-01 TE-02 TE-I
3:57 1.201 102.2 99.3 119.5
0.000 0.0 0.0 0.0
4:00 1.148 103.0 99.8 119.8
0.000 0.0 0.0 0.0
5:00 0.561 84.0 85.6 118.5
0.000 0.0 0.0 0.0
6:00 0.428 79.2 79.0 118.7
0.000 0.0 0.0 0.0
7:00 0.355 77.7 75.0 119.8
0.000 0.0 0.0 0.0
8:00 0.304 76.2 71.6 119.6
0.000 0.0 0.0 0.0
9:00 0.260 75.7 68.9 119.6
0.000 0.0 0.0 0.0
10:00 0.222 75.5 66.0 119.1
0.000 0.0 0.0 0.0
11:00 0.194 75.5 63.6 118.9
0.000 0.0 0.0 0.0
12:00 0.173 75.6 62.3 119.4
0.000 0.0 0.0 0.0
13:00 0.154 75.5 62.6 120.0
0.000 0.0 0.0 0.0
14:00 0.134 75.3 63.7 118.9
0.000 0.0 0.0 0.0
Phase end : [7] 06/10/2023-13:01:45
PLC Duration Phase [7] Chamber vacuum : 10:15
Phase start : [9] Chamber pre-heating 06/10/2023-13:01:45
Time PT-01 TE-01 TE-02 TE-I
14:12 0.130 75.2 63.8 118.7
0.000 0.0 0.0 0.0
15:00 0.751 89.8 90.3 118.5
0.000 0.0 0.0 0.0
Phase end : [9] 06/10/2023-13:03:10
PLC Duration Phase [9] Chamber pre-heating : 1:25

7 / 14 Print Report : 06/10/2023 14:56:53

 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

Phase start : [7] Chamber vacuum 06/10/2023-13:03:10

Time PT-01 TE-01 TE-02 TE-I
15:37 1.201 102.8 103.3 119.3
0.000 0.0 0.0 0.0
16:00 0.936 97.2 99.2 118.5
0.000 0.0 0.0 0.0
17:00 0.741 91.3 92.4 119.8
0.000 0.0 0.0 0.0
18:00 0.610 87.4 87.4 119.8
0.000 0.0 0.0 0.0
19:00 0.510 85.3 82.9 119.5
0.000 0.0 0.0 0.0
20:00 0.422 80.1 78.5 119.0
0.000 0.0 0.0 0.0
21:00 0.360 80.2 75.5 119.4
0.000 0.0 0.0 0.0
22:00 0.303 79.2 73.5 120.1
0.000 0.0 0.0 0.0
23:00 0.257 79.0 72.0 119.0
0.000 0.0 0.0 0.0
24:00 0.200 78.2 73.5 119.8
0.000 0.0 0.0 0.0
25:00 0.149 77.4 74.3 118.8
0.000 0.0 0.0 0.0
Phase end : [7] 06/10/2023-13:13:03
PLC Duration Phase [7] Chamber vacuum : 9:53
Phase start : [6] Chamber heating 06/10/2023-13:13:03
Time PT-01 TE-01 TE-02 TE-I
25:30 0.130 77.2 74.5 120.0
0.000 0.0 0.0 0.0
26:00 0.722 88.6 89.2 119.2
0.000 0.0 0.0 0.0
27:00 1.443 108.4 108.9 118.6
0.000 0.0 0.0 0.0
Phase end : [6] 06/10/2023-13:15:28
PLC Duration Phase [6] Chamber heating : 2:25
Phase start : [29] Heating holding 06/10/2023-13:15:28
Time PT-01 TE-01 TE-02 TE-I
27:55 2.086 121.1 121.4 119.6
0.000 0.4 0.4 0.0
28:00 2.082 121.3 121.6 119.9
0.000 0.4 0.4 0.0
Phase end : [29] 06/10/2023-13:16:28
PLC Duration Phase [29] Heating holding : 1:00
Phase start : [13] Sterilization 06/10/2023-13:16:28
Time PT-01 TE-01 TE-02 TE-I
28:55 2.083 121.2 121.6 120.4
0.000 1.4 1.5 0.0
29:00 2.083 121.2 121.6 120.3
0.000 1.4 1.5 0.0
30:00 2.083 121.2 121.7 120.1
0.000 2.5 2.7 0.0
31:00 2.083 121.2 121.7 119.8
0.000 3.5 3.8 0.0
32:00 2.083 121.2 121.7 119.6
0.000 4.5 5.0 0.0

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 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

33:00 2.083 121.2 121.7 119.3

0.000 5.5 6.1 0.0
34:00 2.083 121.2 121.7 119.0
0.000 6.6 7.3 0.0
35:00 2.083 121.1 121.7 118.8
0.000 7.6 8.4 0.0
36:00 2.083 121.1 121.7 118.5
0.000 8.6 9.6 0.0
37:00 2.083 121.1 121.6 120.3
0.000 9.6 10.7 0.0
38:00 2.083 121.1 121.7 119.8
0.000 10.6 11.9 0.0
39:00 2.083 121.1 121.7 119.3
0.000 11.6 13.0 0.0
40:00 2.083 121.1 121.6 118.8
0.000 12.6 14.1 0.0
41:00 2.083 121.1 121.7 120.9
0.000 13.5 15.3 0.0
42:00 2.083 121.1 121.7 120.1
0.000 14.5 16.4 0.0
43:00 2.084 121.1 121.7 119.6
0.000 15.5 17.6 0.0
44:00 2.083 121.1 121.7 119.0
0.000 16.5 18.7 0.0
45:00 2.083 121.1 121.7 118.5
0.000 17.5 19.9 0.0
46:00 2.082 121.1 121.7 120.4
0.000 18.5 21.0 0.0
47:00 2.083 121.1 121.7 119.8
0.000 19.5 22.2 0.0
48:00 2.083 121.1 121.7 119.2
0.000 20.6 23.3 0.0
Phase end : [13] 06/10/2023-13:36:28
PLC Duration Phase [13] Sterilization : 20:00
Phase start : [21] Chamber vacuum to set-point 06/10/2023-13:36:28
Time PT-01 TE-01 TE-02 TE-I
48:55 2.083 121.1 121.7 118.7
0.000 21.6 24.5 0.0
49:00 2.057 121.0 121.6 118.7
0.000 21.6 24.5 0.0
50:00 1.836 117.0 118.2 119.2
0.000 22.2 25.3 0.0
51:00 1.654 114.0 115.0 118.6
0.000 22.5 25.7 0.0
52:00 1.489 111.0 111.9 118.7
0.000 22.7 25.8 0.0
53:00 1.316 107.4 108.4 118.8
0.000 22.7 25.9 0.0
54:00 1.060 102.6 103.1 119.0
0.000 22.8 26.0 0.0
55:00 0.798 95.1 95.2 119.0
0.000 22.8 26.0 0.0
56:00 0.626 92.8 93.8 119.5
0.000 22.8 26.0 0.0
57:00 0.444 88.4 96.0 118.8
0.000 22.8 26.0 0.0

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 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

58:00 0.296 84.8 97.4 119.3

0.000 22.8 26.0 0.0
59:00 0.203 82.7 98.2 119.0
0.000 22.8 26.0 0.0
Phase end : [21] 06/10/2023-13:46:35
PLC Duration Phase [21] Chamber vacuum to set-point : 10:07
Phase start : [23] Chamber vacuum holding 06/10/2023-13:46:35
Time PT-01 TE-01 TE-02 TE-I
59:02 0.200 82.6 98.2 119.0
0.000 22.8 26.0 0.0
60:00 0.206 81.7 98.7 119.7
0.000 22.8 26.0 0.0
61:00 0.234 80.4 99.1 119.2
0.000 22.8 26.0 0.0
62:00 0.201 79.4 99.4 118.6
0.000 22.8 26.0 0.0
63:00 0.233 78.8 99.6 119.4
0.000 22.8 26.0 0.0
64:00 0.194 78.3 99.7 118.8
0.000 22.8 26.0 0.0
Phase end : [23] 06/10/2023-13:51:35
PLC Duration Phase [23] Chamber vacuum holding : 5:00
Phase end : [5] 06/10/2023-13:51:35
PLC Duration Phase [5] Jacket heating : 64:02
Phase start : [1] Chamber pressurize 06/10/2023-13:51:35
Time PT-01 TE-01 TE-02 TE-I
64:02 0.188 78.3 99.7 118.8
0.000 22.8 26.0 0.0
Phase end : [1] 06/10/2023-13:52:12
PLC Duration Phase [1] Chamber pressurize : 0:36
Phase start : [17] Chamber press. holding with compres.air 06/10/2023-13:52:12
Time PT-01 TE-01 TE-02 TE-I
64:39 2.308 78.3 99.5 117.9
0.000 22.8 26.0 0.0
65:00 2.296 85.3 99.5 117.4
0.000 22.8 26.0 0.0
66:00 2.235 87.9 99.3 116.3
0.000 22.8 26.0 0.0
Phase end : [17] 06/10/2023-13:54:11
PLC Duration Phase [17] Chamber press. holding with compres.air : 2:00
Phase start : [26] Cooling (with shower) 06/10/2023-13:54:11
Time PT-01 TE-01 TE-02 TE-I
66:38 2.248 88.1 99.2 115.7
0.000 22.8 26.0 0.0
Phase start : [60] Back pressure 06/10/2023-13:54:11
Time PT-01 TE-01 TE-02 TE-I
66:38 2.248 88.1 99.2 115.7
0.000 22.8 26.0 0.0
67:00 2.254 85.2 96.9 115.2
0.000 22.8 26.0 0.0
68:00 2.259 82.3 87.4 105.9
0.000 22.8 26.0 0.0
69:00 2.264 69.0 80.6 99.4
0.000 22.8 26.0 0.0
70:00 2.229 59.1 76.8 93.9
0.000 22.8 26.0 0.0

10 / 14 Print Report : 06/10/2023 14:56:53

 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

71:00 2.240 53.8 74.8 94.5

0.000 22.8 26.0 0.0
72:00 2.235 49.0 71.9 94.8
0.000 22.8 26.0 0.0
73:00 2.257 44.8 69.2 94.4
0.000 22.8 26.0 0.0
74:00 2.290 42.1 67.0 93.6
0.000 22.8 26.0 0.0
75:00 2.239 40.2 65.0 92.6
0.000 22.8 26.0 0.0
Phase end : [26] 06/10/2023-14:02:34
PLC Duration Phase [26] Cooling (with shower) : 8:23
Phase end : [60] 06/10/2023-14:02:34
PLC Duration Phase [60] Back pressure : 8:23
Phase start : [40] Chamber water drain 06/10/2023-14:02:34
Time PT-01 TE-01 TE-02 TE-I
75:01 2.238 40.1 65.0 92.6
0.000 22.8 26.0 0.0
76:00 2.067 43.7 67.0 91.6
0.000 22.8 26.0 0.0
77:00 1.595 42.8 66.4 90.4
0.000 22.8 26.0 0.0
78:00 1.286 44.2 65.8 89.0
0.000 22.8 26.0 0.0
Phase end : [40] 06/10/2023-14:05:43
PLC Duration Phase [40] Chamber water drain : 3:08
Phase start : [11] Duration vacuum & steam injection 06/10/2023-14:05:43
Time PT-01 TE-01 TE-02 TE-I
78:10 1.250 44.7 65.8 88.8
0.000 22.8 26.0 0.0
79:00 1.113 46.6 65.9 87.6
0.000 22.8 26.0 0.0
80:00 0.405 44.6 65.4 86.3
0.000 22.8 26.0 0.0
81:00 0.217 53.4 62.7 85.1
0.000 22.8 26.0 0.0
82:00 0.195 58.7 59.9 83.8
0.000 22.8 26.0 0.0
83:00 0.219 61.8 62.0 82.6
0.000 22.8 26.0 0.0
Phase end : [11] 06/10/2023-14:10:42
PLC Duration Phase [11] Duration vacuum & steam injection : 5:00
Phase start : [20] Atm pressure balance 2 06/10/2023-14:10:42
Time PT-01 TE-01 TE-02 TE-I
83:09 0.222 62.1 62.3 82.4
0.000 22.8 26.0 0.0
84:00 0.991 61.0 63.3 81.3
0.000 22.8 26.0 0.0
Phase end : [20] 06/10/2023-14:12:21
PLC Duration Phase [20] Atm pressure balance 2 : 1:39
Phase start : [11] Duration vacuum & steam injection 06/10/2023-14:12:21
Time PT-01 TE-01 TE-02 TE-I
84:48 1.003 60.3 63.7 80.4
0.000 22.8 26.0 0.0
85:00 0.782 58.4 63.5 80.2
0.000 22.8 26.0 0.0

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 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

86:00 0.352 57.4 63.4 79.1

0.000 22.8 26.0 0.0
87:00 0.248 61.7 63.2 78.1
0.000 22.8 26.0 0.0
88:00 0.226 61.5 62.9 77.2
0.000 22.8 26.0 0.0
89:00 0.222 61.7 62.7 76.2
0.000 22.8 26.0 0.0
Phase end : [11] 06/10/2023-14:17:21
PLC Duration Phase [11] Duration vacuum & steam injection : 5:00
Phase start : [20] Atm pressure balance 2 06/10/2023-14:17:21
Time PT-01 TE-01 TE-02 TE-I
89:48 0.221 62.1 62.7 75.5
0.000 22.8 26.0 0.0
90:00 0.558 62.0 63.0 75.4
0.000 22.8 26.0 0.0
91:00 1.003 61.2 63.5 74.5
0.000 22.8 26.0 0.0
Phase end : [20] 06/10/2023-14:19:00
PLC Duration Phase [20] Atm pressure balance 2 : 1:39
Phase start : [38] Drying vacuum pulses 06/10/2023-14:19:00
Time PT-01 TE-01 TE-02 TE-I
91:27 1.004 60.7 63.6 74.1
0.000 22.8 26.0 0.0
Phase start : [15] Jacket heating 2 06/10/2023-14:19:00
Time PT-01 TE-01 TE-02 TE-I
91:27 1.004 60.7 63.6 74.1
0.000 22.8 26.0 0.0
92:00 0.556 57.0 63.3 74.1
0.000 22.8 26.0 0.0
93:00 0.292 58.6 62.0 80.4
0.000 22.8 26.0 0.0
94:00 0.217 59.5 61.4 110.1
0.000 22.8 26.0 0.0
95:00 0.900 61.0 61.6 119.1
0.000 22.8 26.0 0.0
96:00 0.332 57.5 60.1 118.8
0.000 22.8 26.0 0.0
97:00 0.348 58.5 59.3 119.9
0.000 22.8 26.0 0.0
98:00 0.497 58.5 59.2 119.5
0.000 22.8 26.0 0.0
99:00 0.228 59.5 58.9 119.3
0.000 22.8 26.0 0.0
100:00 0.708 65.6 58.9 119.1
0.000 22.8 26.0 0.0
101:00 0.277 59.1 58.0 119.0
0.000 22.8 26.0 0.0
102:00 0.839 63.8 58.0 119.0
0.000 22.8 26.0 0.0
103:00 0.341 58.6 57.0 119.1
0.000 22.8 26.0 0.0
104:00 0.604 61.3 56.7 119.3
0.000 22.8 26.0 0.0
105:00 0.418 59.0 56.5 119.5
0.000 22.8 26.0 0.0

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 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

106:00 0.290 59.7 56.3 119.9

0.000 22.8 26.0 0.0
107:00 0.510 60.2 56.1 119.9
0.000 22.8 26.0 0.0
108:00 0.216 59.1 55.7 118.7
0.000 22.8 26.0 0.0
109:00 0.615 63.2 55.5 119.1
0.000 22.8 26.0 0.0
110:00 0.243 58.5 54.9 119.7
0.000 22.8 26.0 0.0
111:00 0.750 65.4 55.2 119.9
0.000 22.8 26.0 0.0
112:00 0.273 58.3 54.7 118.8
0.000 22.8 26.0 0.0
113:00 0.890 63.7 54.7 119.2
0.000 22.8 26.0 0.0
114:00 0.307 58.2 54.3 119.6
0.000 22.8 26.0 0.0
115:00 0.801 62.5 54.1 119.0
0.000 22.8 26.0 0.0
116:00 0.345 58.1 53.9 118.7
0.000 22.8 26.0 0.0
117:00 0.686 61.4 53.6 119.1
0.000 22.8 26.0 0.0
118:00 0.384 58.4 53.6 119.4
0.000 22.8 26.0 0.0
119:00 0.540 60.3 53.3 119.1
0.000 22.8 26.0 0.0
120:00 0.427 58.8 53.5 118.6
0.000 22.8 26.0 0.0
121:00 0.401 59.5 53.2 119.0
0.000 22.8 26.0 0.0
Phase end : [38] 06/10/2023-14:49:00
PLC Duration Phase [38] Drying vacuum pulses : 30:00
Phase end : [15] 06/10/2023-14:49:00
PLC Duration Phase [15] Jacket heating 2 : 30:00
Phase start : [33] Jacket steam drain 06/10/2023-14:49:00
Time PT-01 TE-01 TE-02 TE-I
121:27 0.883 63.7 53.3 118.6
0.000 22.8 26.0 0.0
Phase start : [1] Chamber pressurize 06/10/2023-14:49:00
Time PT-01 TE-01 TE-02 TE-I
121:27 0.883 63.7 53.3 118.6
0.000 22.8 26.0 0.0
122:00 1.791 67.7 53.7 107.5
0.000 22.8 26.0 0.0
123:00 1.831 67.3 54.4 103.3
0.000 22.8 26.0 0.0
124:00 1.814 67.4 54.9 101.8
0.000 22.8 26.0 0.0
125:00 1.752 67.7 55.3 101.3
0.000 22.8 26.0 0.0
Phase end : [33] 06/10/2023-14:53:00
PLC Duration Phase [33] Jacket steam drain : 4:00
Phase end : [1] 06/10/2023-14:53:00
PLC Duration Phase [1] Chamber pressurize : 4:00

13 / 14 Print Report : 06/10/2023 14:56:53

 De Lama S.p.A.
Sterilisasi akhir 0.cyc_20231006124734
MASTER 6 -- Rel 7.2.3

Phase start : [18] Chamber cooling 06/10/2023-14:53:00

Time PT-01 TE-01 TE-02 TE-I
125:27 1.762 67.7 55.4 101.1
0.000 22.8 26.0 0.0
Phase start : [60] Back pressure 06/10/2023-14:53:00
Time PT-01 TE-01 TE-02 TE-I
125:27 1.762 67.7 55.4 101.1
0.000 22.8 26.0 0.0
126:00 1.848 65.1 55.5 102.5
0.000 22.8 26.0 0.0
Phase end : [18] 06/10/2023-14:53:34
PLC Duration Phase [18] Chamber cooling : 0:34
Phase end : [60] 06/10/2023-14:53:34
PLC Duration Phase [60] Back pressure : 0:34
Phase start : [24] Chamber drain 06/10/2023-14:53:34
Time PT-01 TE-01 TE-02 TE-I
126:01 1.838 65.0 55.5 102.5
0.000 22.8 26.0 0.0
127:00 1.381 55.3 55.4 96.5
0.000 22.8 26.0 0.0
128:00 1.136 54.0 55.3 95.0
0.000 22.8 26.0 0.0
Phase end : [24] 06/10/2023-14:56:14
PLC Duration Phase [24] Chamber drain : 2:40
Phase start : [16] Cycle verify 06/10/2023-14:56:14
Time PT-01 TE-01 TE-02 TE-I
128:41 1.050 54.2 55.2 94.0
0.000 22.8 26.0 0.0

Phase end : [16] 06/10/2023-14:56:50

PLC Duration Phase [16] Cycle verify : 0:36

Cycle summary :
Start Cycle : 06/10/2023-12:47:33
End Cycle : 06/10/2023-14:56:15
Cycle Result : Cycle End OK
Sterilization Time : 20 min
Sterilization Duration : 20 min
Min Temp. Steriliz. : 121.02 °C Temperature TE-01
Max Temp. Steriliz. : 121.75 °C Temperature TE-02
Min Letality Factor : 21.6 Temperature TE-01
Max Letality Factor : 24.5 Temperature TE-02

Operator Signature : Signature Responsible :

14 / 14 Print Report : 06/10/2023 14:56:53