PHARMACEUTICAL CONTAINER CLOSURE INTEGRITY TESTING CHECKLIST

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--- TEST PLANNING & PREPARATION ---
[ ] Test Objective(s)
[ ] Test Methodology (Vacuum Decay, Pressure Decay, Helium Leak Testing, Direct Leak Testing)
[ ] Sample Size (Units)
[ ] Planned Test Start Date
[ ] Planned Test End Date
[ ] Acceptance Criteria Source (Company Standard, Regulatory Guidance, Client Requirement)

--- EQUIPMENT CALIBRATION & VERIFICATION ---
[ ] Last Calibration Date
[ ] Calibration Frequency (in months)
[ ] Temperature Reading During Calibration (Â°C)
[ ] Pressure Reading During Calibration (PSI)
[ ] Calibration Standard Used (NIST traceable standard, In-house standard, Other - Specify in Long Text)
[ ] Calibration Details/Comments (if 'Other' selected above)
[ ] Calibration Certificate (PDF)
[ ] Technician Signature

--- SAMPLE SELECTION & HANDLING ---
[ ] Number of Samples Selected
[ ] Sampling Method (Random Sampling, Stratified Sampling, Judgmental Sampling)
[ ] Sample Collection Date
[ ] Sample Collection Time
[ ] Sample Collection Location
[ ] Sample Description (Appearance, Condition)
[ ] Container Type (Glass, Plastic, Metal)
[ ] Sample Collector Signature

--- LEAK TESTING PROCEDURE ADHERENCE ---
[ ] Leak Testing Method (Vacuum Decay, Pressure Decay, Helium Leak Testing, Other (Specify))
[ ] Vacuum Level (mmHg)
[ ] Pressure (psi)
[ ] Leak Rate Limit (cc/min)
[ ] Test Duration (minutes)
[ ] Specific Procedure Steps Followed (Detailed)
[ ] Procedure Version Used (Version 1.0, Version 1.1, Version 1.2, Other (Specify))
[ ] Operator Signature

--- DATA ACQUISITION & RECORDING ---
[ ] Vacuum Decay Test Pressure (mmHg)
[ ] Vacuum Decay Test Duration (seconds)
[ ] Leak Rate (cc/second)
[ ] Date of Test
[ ] Time of Test Start
[ ] Observations During Testing
[ ] Test Result (Pass/Fail) (Pass, Fail)
[ ] Operator Signature

--- RESULTS EVALUATION & ACCEPTANCE CRITERIA ---
[ ] Leak Rate (ml/min)
[ ] Vacuum Decay Constant (k-value)
[ ] Method Used (e.g., Vacuum Decay, Pressure Decay, Helium) (Vacuum Decay, Pressure Decay, Helium Leak Testing, Other - Specify in Long Text)
[ ] Detailed Result Commentary
[ ] Pass/Fail Determination (Pass, Fail, Conditional - Requires Further Investigation)
[ ] Justification for Pass/Fail Determination
[ ] Date of Result Evaluation
[ ] Evaluator Signature

--- DEVIATION MANAGEMENT & INVESTIGATION ---
[ ] Detailed Description of Deviation
[ ] Date of Deviation Occurrence
[ ] Time of Deviation Occurrence
[ ] Severity Level (e.g., Minor, Moderate, Major) (Minor, Moderate, Major)
[ ] Quantity Affected (if applicable)
[ ] Root Cause Analysis
[ ] Corrective Action Plan
[ ] Corrective Action Completion Date
[ ] Investigator Signature

--- REPORT GENERATION & REVIEW ---
[ ] Executive Summary of Findings
[ ] Number of Containers Tested
[ ] Number of Failed Containers
[ ] Overall Conclusion (Pass/Fail/Conditional) (Pass, Fail, Conditional)
[ ] Detailed Description of Anomalies (if any)
[ ] Report Issue Date
[ ] Reviewer Signature
[ ] Supporting Data/Graphs (optional)

--- MAINTENANCE AND CLEANING OF EQUIPMENT ---
[ ] Last Cleaning Date
[ ] Cleaning Procedure Followed (Detailed Description)
[ ] Cleaning Solution Concentration (%)
[ ] Areas Cleaned (Check all that apply) (Exterior Surfaces, Sensor Ports, Internal Components, Fluid Pathways, Power Supply)
[ ] Cleaning Verification Photos (Optional)
[ ] Cleaning Effectiveness Verification Method (Visual Inspection, Residue Testing, Other (Specify))
[ ] Other Method Description (if selected)

--- DOCUMENTATION REVIEW AND TRACEABILITY ---
[ ] Document Review Date
[ ] Summary of Document Review Findings
[ ] Document Status (Approved, Rejected, Revised)
[ ] Document Revision Number
[ ] Upload Reviewed Document (if revised)
[ ] Reviewer Signature
[ ] Associated Batch/Lot Number

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