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Get Sterility Failure Investigation

Ons found 5. Possible causes 6. Corrective action 7. Preventative action 8. Disposition of filling room 9. Documentation Approval of Investigation DR 1 Purpose of report The purpose of this document is to provide a summary report of the incident investigation conducted into: 2 Batch Details Product Name Date of Manufacturing Product Code Container and size Terminally sterilized Y/N Batch # Filling Room # Filling Machine Autoclave Cycle Sterility Test Details Date Technician Num.

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