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Ster Validation Report

The document summarizes the results of a steam sterilization demo session conducted on March 4, 2008. The session involved heating items to 134°C for 8 minutes with a pulse vacuum drying. All validation tests were passed, including tests for temperature equilibration, holding time, homogeneous temperature, temperature fluctuation, pressure deviation and lethality calculations. Individual lethality values for 5 items were all above the minimum required value of 15.

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97 views2 pages

Ster Validation Report

The document summarizes the results of a steam sterilization demo session conducted on March 4, 2008. The session involved heating items to 134°C for 8 minutes with a pulse vacuum drying. All validation tests were passed, including tests for temperature equilibration, holding time, homogeneous temperature, temperature fluctuation, pressure deviation and lethality calculations. Individual lethality values for 5 items were all above the minimum required value of 15.

Uploaded by

Sf Bztprk
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Operator: John Doe Vessel: No.

X
Process: Demo Product: Steam Autoclave
Session Start: 03-04-2008 12:39:02 Time Zone: Rom, normaltid (UTC offset 01:00:00)
Session Stop: 03-04-2008 14:18:47
Session Name: Demo
Session Text: Prog. 1: 134 °C / 8 min. / pulse vacuum drying

Validation Report

Total Test Result Passed

Name: Validation Report


Description: Steam sterilization
Cycle:
Input Parameters
Process Temperature : 134,00 °C
Process Temperature Band (K): 3,00
Maximum Temperature Fluctuation (K): 1,00
Maximum Temperature Difference (K): 2,00
Maximum Equilibration Time: 00:00:30
Minimum Holding Time: 00:03:00

E
Maximum Pressure Deviation: 0,1000 bar
Equilibration Time
Equilibration Start Time: 03-04-2008 13:12:44
Equilibration End Time:
Equilibration Duration:
PL
03-04-2008 13:12:46
00:00:02
Max. allowed Equilibration Duration: 00:00:30
Equilibration Test Result: Passed
Process band
Holding Start Time: 03-04-2008 13:12:46
Holding End Time: 03-04-2008 13:21:21
M
Holding Duration: 00:08:35
Min. allowed Holding Duration: 00:03:00
Holding Test Result: Passed
Homogeneous Band
SA

Homogeneous Temperature (K): 0,05


Max. Allowed Homogeneous Temperature (K): 2,00
Homogeneous Temperature Test Result: Passed
Fluctuation Band
Temperature Fluctuation (K): 0,86
Max. Allowed Temperature Fluctuation (K): 1,00
Temperature Fluctuation Test Result: Passed
Saturated Steam Analysis

Pressure Deviation: 0,0338 bar


Max. Pressure Deviation: 0,1000 bar
Pressure Deviation Test Result: Passed
Summary Report

Name Fluctuation (°C) Deviation


1 0,82 0,0331 bar
2 0,84 0,0338 bar
3 0,83 0,0318 bar
4 0,84 0,0293 bar
Operator/Date:

- Generated by ValSuite Pro ver. 2.7.10.0 -


Printed: 26-04-2010 14:16:09 Page 1 of 2
Operator: John Doe Vessel: No. X
Process: Demo Product: Steam Autoclave
Session Start: 03-04-2008 12:39:02 Time Zone: Rom, normaltid (UTC offset 01:00:00)
Session Stop: 03-04-2008 14:18:47
Session Name: Demo
Session Text: Prog. 1: 134 °C / 8 min. / pulse vacuum drying

Afløb 0,84 0,0313 bar


Lethality Calculation:
Lethality - Max. Pressure Deviation: 0,1000 bar
Lethality - Min. Saturated Steam Duration: 00:03:00
Lethality - Min. Lethality value: 15,00
Lethality - Reference Temperature: 121,11 °C
Min. Temperature for Lethality-Calculation: 91,11 °C
Lethality - Z-Value: 10 °C
Individual Analysis
Lethality Lethality Value Saturated Steam Saturated Steam Duration
Name Value Status Duration Status

Lethality - 1 (Saturated Steam) 198,78 Passed 00:08:35 Passed


Lethality - 1 (Normal) 198,78 Passed N/A N/A

E
Lethality - 2 (Saturated Steam) 199,04 Passed 00:08:35 Passed
Lethality - 2 (Normal) 199,04 Passed N/A N/A
Lethality - 3 (Saturated Steam) 198,12 Passed 00:08:35 Passed
Lethality - 3 (Normal) 198,12
PL
Passed N/A N/A
Lethality - 4 (Saturated Steam) 198,22 Passed 00:08:35 Passed
Lethality - 4 (Normal) 198,22 Passed N/A N/A
Lethality - 5 (Saturated Steam) 198,11 Passed 00:08:35 Passed
M
SA

Operator/Date:

- Generated by ValSuite Pro ver. 2.7.10.0 -


Printed: 26-04-2010 14:16:09 Page 2 of 2

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