Leak Test Machine (Bag – Pressure/Vacuum) – Qualification Execution Checklist

Qualification Execution Checklist

Equipment: Leak Test Machine (Bag – Pressure/Vacuum)

Subcategory: IV Infusions (LVP/SVP – Bags/Bottles)

Area: Production/QC

DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes

CSV Required: Yes

Pre-start




Calibration/PM Status Verification


Protocol Readiness and Approvals


Execution Controls



Review and Approvals



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