121 Bowie Dick test

GOOD VALIDATION PRACTICE (cGVP)
1

Can anyone tell me where I can get a 121 Bowie dick test pack or test sheets.

I can only find 134 Degrees C. packs/ sheets and 121 Degrees C. for 8.3 minutes packs, these are not siutable.

:rolleyes:

2

Hi Philwil

try:

http://www.steris.com/products/view.cfm?id=2924

Thats where I have got them.

Regards
Alex
Alex Kennedy

3

Hi Philwil and Alex :slight_smile:

whether bowie dick test can be replaced with a leak test? because we did not do bowie dick test but the leak test…
is that enough??

4

[quote=Muhammad Hendra]Hi Philwil and Alex :slight_smile:

whether bowie dick test can be replaced with a leak test? because we did not do bowie dick test but the leak test…
is that enough??[/quote]

Yes, you should perform Bowie Dick test and Leak test (EN:285). These tests are different because Bowie Dick test show that if your vacuum phases are effective to remove air from chamber and allow steam penetration and Leak rate test show if your chamber is not sealed good and air inlet the chamber. More informations you can find in HTM 2010 (EN 285)

5

Dear Joksavs,
Thank you so much for the answer, now i know that bowie dick test has a different function with Leak test and we should do both of these tests.

6

Dear all,
We sterilized the autoclave in 121 degrees celcius.
The Bowie-Dick Test run the sterilizer for 3,5 minutes at 132-134 degrees celsius.
So what should we do?

7

You can not perform your regular cycle for testing BD test pack. When performing the test at 134°C, the sterilization plateau is no longer than 3.5 minutes, and the disappearance of the temperature depression has little effect on the sensitivity of the Bowie Dick test. When performing the test at 121°C, the sterilization plateau can range from 15 minutes to in excess of 30 minutes. The rate of disappearance of the temperature depression still however, takes 2 to 4 minutes, thus increasing the risk of a false positive result. The sensitivity of the Bowie Dick test at 121ºC will be potentially reduced as a consequence of this and the final result of the test bought into question. The original Bowie Dick test principle therefore, cannot equally apply to short (3.5 mins) and long (15+ mins) sterilization plateau times. There are Test Pack to counteract this problem by producing a Bowie Dick test that has a maximum plateau of 8.3 minutes. This enables the sensitivity of a 121°C Bowie Dick test to be comparable to that of a 134°C Bowie Dick test. It is important that the product is used with a sterilization plateau that does not exceed 8.3 minutes. This will necessitate a separate cycle, which should be identical to the cycle used for sterile product production in all but the sterilization plateau time.