Autoclave Validation-Bowie‐Dick Test

Why is Bowie‐Dick cycle set for 8 min?
Any references for the above?

1080 sec as per HTM 2010

As it is a class-2 type of chemical indicar,as per that type of indicator may be it needed so,
As per manfactur recommendation &as per guide lines

Have you a validation protocol of autoclave

Not only manufacturer recommendation it will be ask in guidelines the air-removal and heat penetration is must be performed in autoclave chamber.

ISO 11140 consists of the following parts, under the general title Sterilization of health care products — Chemical indicators :

  • Part 1: General requirements
  • Part 2: Test equipment and methods
  • Part 3: Class 2 indicators for steam penetration test sheets
  • Part 4: Class 2 indicators for steam penetration test packs
  • Part 5: Class 2 indicators for air removal test sheets and packs

Sir, Bowie Dick test methods as per HTM ( CFFP) revised required as recommended by manufacturer instructions.
Currently its in pharmaceutical practice HTM 2010 # 1020+ 60 secs .
But now a days after revision of HTM to CFFP its contents recommended by manufacturer.
Manufacturer reference can be addressed.
This is only perform to dynamic air removal.
Yes, you can select if it is recommended 8 mints


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