Determining sample size for device sterility

bob44

Starting to get Involved
#1
We'll be producing a sterile device in 500 unit lots.
We cannot have any device sold that isn't sterile. But like testing bullets for function, we can't fire them all as we'd have none left to sell.
How do we determine the number of units per lot to test??
 
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planB

Trusted Information Resource
#2
Bob,

you have to validate your sterilisation process, since you can only verify sterility by adestructive testing that renders the product un-usable for its intended use.

Still, whether you employ an ethylene oxide or irradiation sterilisation process, the respective standards provide you with guidance how to validate single batches:

Ethylene oxide: ISO 11135:2014/AMD 1:2018, Annex E, Single Batch release

Irradiation: ISO 11137-2:2013, sections 9.3 and 9.5, Procedure for Method VDmax25/15 for a single production batch

HTH,
 

bob44

Starting to get Involved
#3
Thanks PlanB.
Our device is manufactured aseptically with no terminal sterilization process like e-beam or gas.
We've done a media fill batch of a lot and passed fine.
Does this help provide guidance as to which ISO would be applicable?
 
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