Switching sterilization methods

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Alyssa

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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?
 
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