When is Bioburden Testing Required?

kmclear58

Registered
If we are manufacturing a medical device in a non-certified clean room that is sent out to be packaged in a cleanroom & sterilized does routine bioburden testing monitoring need to be done during manufacturing or can it be done during packaging or by the sterilizer? Do some sterilization validations contain bioburden testing and monitoring?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Work with your sterilizer to validate the method using worst-case samples.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Not certain but there is a question before that answer. What method are you using to sterilize? Ethylene Oxide? Radiation? I think the method determines the standard to use.
 
ISO 11737-1, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
 

mteedc

Registered
If I have validated the EO process to overkill (for sterilization of medical devices) and each cycle is run with a BI, do I need to perform routing bioburden monitoring?
 

Cthames

Involved In Discussions
If I have validated the EO process to overkill (for sterilization of medical devices) and each cycle is run with a BI, do I need to perform routing bioburden monitoring?
Yes you would. The idea is you measure bioburden to establish a baseline. Then, you perform a sterilization validation to ensure your sterilization process is capable of sterilizing product's at that baseline. You must do routine monitoring of bioburden in order to ensure your baseline is not shifting, as your sterilization validation is performed with that baseline in mind.
 
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