Ethylene oxide sterilization sterilizer design/operation

The overall scheme of validation of ethylene oxide sterilization is no different from validation of any other process. With new equipment it requires careful consideration of design before specification (Design Qualification), confirmation that received equipment conforms to its specification (Installation Qualification), and confirmation that received equipment can perform its specified functions when assembled, plumbed in, and linked up to local services (Operational Qualification). 

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