Question regarding sterile filter hold time validation

The Question posed on LinkedIn:

How to validate maximum hold time for product sterile filter after autoclave sterilization? Any link to regulatory guidelines is much appreciated.

My reply was this:

Hi Hany. I’ve sourced a couple of articles for you that may be of assistance:

1.  Defining a Strategy For The Validation and Qualification of Sterile Filtration Processes…

2. Regulatory Trends in Manufacturing of Sterile Medicinal Products by Filtration

A nice list of FDA guidance/regulations is included in Aseptic Processing of Biological Products – Current Regulatory Issues such as 21 CFR 211.113 and PDA Technical Report No. 26 (1997) final (Sterilizing Filtration of Liquids)

Kind Regards Paul