Learnaboutgmp Community

Clean hold time

Hallo,
I have the following question: If I sterilized the equipment before process using and prove bioburden and TOC after sterilizing, will I need to evaluate the clean hold time. I think I has to to evaluate the clean hold time only for equipment which is cleaned, stored and than using for the process without sterilization.

Thanks for your comments

not clean hold time but sterilization expiration would be needed.

I agree with Meyert, but would add the holding time before cleaning and/or sterilizing, to validate the initial bioburden before sterilizing, which the sterilization method could handle (sterilization is a x-log bioburden reduction, the higher the initial bioburden is, the higher the failure probability gets).

Regards

Alfred

I think yes, HOLD time study is needed to prove the time of Holding after sterilisation.