Sterilization validation after changing sterilization process provider

#1
Hi!
The company is changing their EtO sterilization vendor. Am I correct in saying that the sterilization validation and biocompatibility testing will need to be repeated?
Thank you!
 
Elsmar Forum Sponsor
#3
Thank you. I am familiar with that guidance but the change is NOT being evaluated for a possible 510(k). The question is whether or not the sterility testing needs to be repeated after switching vendors.
 

planB

Super Moderator
#4
spinning.top,

a change in sterilization process (provider) requires risk assessment within the company's change-control system: depending on the nature of the change and the outcome of your assessment, the existing sterilisation validation & biocompatibility evaluation (especially in terms of potential residuals according to ISO 10993-7, but maybe not limited to residuals) may or may not be affected. Have a look to AAMI TIR28:2016 for guidance of some of these apects.

Also consider the impact of the proess change to packaging stability and performance as well as product performance (maybe even product stability).

HTH,
Gerhard
 
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