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

QA RA Small Med Dev Company
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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
 
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