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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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Keywords relevant to Sterility Failure Investigation

  • LAF
  • Steritest
  • ipa
  • Endotoxin
  • Validations
  • HEPAs
  • stoppages
  • gowning
  • sterilisation
  • glossary
  • Calibrations
  • exp
  • contaminant
  • autoclave
  • Expiry
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