When is Bioburden Testing Required?

#1
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?
 
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Ed Panek

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#4
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.
 

indubioush

Quite Involved in Discussions
#5
ISO 11737-1, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
 
#6
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
#9
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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