Bowie Dick Test

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Dear all;

During the autoclave validation sometimes all of the 3 runs couldnot be finished and I have to continue on the following day. According our procedure we control the Bowie Dick Test every day if it is okay or not. However, when I have to continue the runs on the following day should I perform the Bowie Dick Test between runs or it is also okay to perform it after the thrid run.

I am waiting for your opinions.

Thanks in advance.

2

[quote=sibelh]Dear all;

During the autoclave validation sometimes all of the 3 runs couldnot be finished and I have to continue on the following day. According our procedure we control the Bowie Dick Test every day if it is okay or not. However, when I have to continue the runs on the following day should I perform the Bowie Dick Test between runs or it is also okay to perform it after the thrid run.

I am waiting for your opinions.

Thanks in advance.[/quote]

Dear,

my opinion is that is better to perform BD test before third validation test not after.

And,if you using TC perform leak test before validation tests to seen is your feedtrough closed.

3

PDA Technical Report: 48

Bowie Dick test is performed for air removal cycles (Empty Chamber Thermal Mapping) during FAT, SAT and OQ cycles.

4

Dear sibelh,
Before validation itself we need to prepare procedure for Autoclave validation PQ protocal.
It is not necessary to perform Bowie Dick test every day.
After validation as per SOP we need to carryout the test. once in a week people will do the Bowie Dick test on validated Autoclaves.