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Re: Eto Certificate of Sterilization
Presumably your contract manufacturer is subcontracting the actual sterilization to a company specializing in that service, or you make that contractural arrangement directly yourselves. If the switch of sterilization processes also entails a switch of sterilization vendors, then not only will you care about certificates, but you may also want to oversee your contract manufacturer's interaction with the sterilization vendor in regard to packaging changes, possibly product and packaging materials changes, and packaging-process and sterilization-process revalidations.
If the sterilization subcontractor is located in the US, they'll be an FDA registered Establishment that conforms to ISO 11135 and the appropriate AAMI TIR in regard to their EtO process.
Presuming that they have other medical device customers, you can most easily answer your question about certificate format by just asking them to send you a sample of the certificate that they use with another customer like you. The specific format is unimportant as long as the processing record chain is clear in regard to validation, assurance that the operational cycle matched the validated cycle, transfer and continuity of control, proper sterilization labeling for loads in transit, and quarantine until release-verification is received.
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Eto Certificate of Sterilization (vs. gamma irradiation)
Linear Mode
