acceptable provided that there are multiple wrappings, as appropriate to the number of critical stages of entry to the clean area, and enter through an airlock with the appropriate surface sanitization precautions. The sterilisation process (es) applied should be validated and the equipment used to sterilize should include the common materials to use by the manufacturer. Proposed change (if any): change the sentence. “The
acceptable provided that there are multiple wrappings, as appropriate to the number of critical stages of entry to the clean area, and enter through an airlock with the appropriate surface sanitization precautions. The sterilisation process (es) applied should be validated and the equipment used to sterilize should include the common materials to use by the manufacturer. Proposed change (if any): change the sentence. “The
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