Transitioning from Terminal Sterilization to Aseptic Processing

[Yvonne]

Dear All,

We are considering transitioning from terminal sterilization to aseptic processing for one of our sterile medical device.

I would like to know if there are any specific standards that a manufacturer should comply with to ensure that the aseptic processing of a manufacturing facility is acknowledged by the certification body? Also, would like to understand the regulatory framework of transitioning from terminal sterilization to aseptic processing.

What will the auditor inspect to ensure that the aseptic processing of manufacturing a sterile device complies with certain standards?

Thanks!

 

[planB]

Have a look into the ISO 13408 series. The introduction to ISO 13408-1:2023 actually discourages using aseptic processing unless manufacturing is not possible otherwise:

Wherever possible, health care products intended to be sterile should be terminally sterilized in their final sealed container by a terminal sterilization process, which has been validated to achieve a specified sterility assurance level (SAL)

and points you to about 50 other guidance documents that you may want to consider.

HTH,

 

[chris1price]

In addition to ISO13408, I would also look at Eudralex Vol 4, Annex 1, which covers aseptic processing of pharmaceuticals. This will provide much cleanroom practices, gowning, etc. While not directly applicable to devices, it is likely to be the starting point for many inspectors.