Clean hold time

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

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

2

not clean hold time but sterilization expiration would be needed.

3

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

4

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