This procedure defines the requirements for Gamma sterilization validation and revalidation using the VD Max25 method according to ISO 11137-1.
This procedure is intended to provide guidance to the person coordinating gamma sterilization validation by a contract sterilizer in accordance with EVS-EN ISO 11137-1:2015, and EVS-EN ISO 11137-1:2015. Suppliers performing the validation on behalf of your company may rely on their own procedure(s) instead of this procedure, but the person coordinating the validation should verify that the contract sterilizer is in compliance with applicable standards.
This procedure applies to Method VD Max25 for multiple batches only, not applicable for the single batch method.
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SYS-047 Gamma Sterilization Validation Procedure – The purpose of this procedure is to define the requirements for Gamma sterilization validation and revalidation using the VD Max25 Method which has been outsourced by your company to a contract sterilizer.
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