Ethylene oxide sterilization vendor change

[sunnygreet]

Hello,
We are a small medical device manufacturing company and our vendor for Ethylene Oxide sterilization is shutting down their site that we were currently using. The same vendor has proposed an alternate site at a different location of the same chamber size.

Please advise on what is required to validate the new site and how to prove equivalency.

Thank You,
Sunny

 

[EmiliaBedelia]

1) Look at the standards that were referenced in the initial sterilization validation. Standards like ISO 11135 or ISO 11137-1 should be referenced in your existing sterilization documentation.
2) Your vendor will be able to help you with re-validation. If they triggered the change you should absolutely be asking them to support you in making the transition to their other site.

 

[Ed Panek]

Regulators don’t care if it’s the same vendor or chamber size .... they care about process control and repeatability. So you’ve got to demonstrate that sterilization at the new site will deliver the same validated Sterility Assurance Level and product safety. It sounds like a major change to a critical supplier. Review FDA Blue Book 2017 to see if a 510(k) Special may need to be amended to your clearance.

 

[v9991]

dont assume equivalency based on the chamber size alone; consideration of specific factors of utilities, process parameters etc have influence.
1. Start with Vendor for qualification and calibration reports; also understand the historical data
2. complete the site quality assessment and agreement.
3. conduct process comparison or equivalence ( wrt parameters like Temperature, exposure time, concentration, temperature and humidity conditions ) and related quality risk assessment.
4. Qualification of new sterilisation process and validation cycle ( load configuration / pattern )
5. Equivalency evaluation wrt bioburden reduction, and any other challenges + continual monitoring criteria
6. regulatory & customer / client considerations

Document Everything meticulously,