Switching sterilization methods

[Alyssa]

Questions concerning change in sterilization methods. Our current processing method is gamma, but we're looking into e-beam and x-ray for both cost savings and sustainability. Has anyone undergone such a change that could provide a broad overview of the change process? We're aware that we would need to repeat biocompatibility studies, package integrity testing, stability, and the sterilization revalidations, then update labeling, refile licenses/provide NoCs. Am I missing anything?

Also, if anyone could provide recommendations for E-beam or x-ray companies on the east coast?

 

[planB]

Steris (I am not affiliated) is encouraging manufactures a lot to switch due to capacity issues (and Co-60 issues), and has plenty of related materials on their website and on YT.

While you do have to re-evaluate biocompatibility (including product stability over its lifetime), it may depend on your device specifics whether you really have to repeat studies in this context: after all, these sterilisation modalities are so closely related that they are governed by the very same ISO 11137 series.

Sterile barrier system: in case you fulfill the very same packaging specification at t=0 after sealing and sterilisation, this could be the basis of a justification, why you would not repeat packaging performance/stability testing.

HTH,