Pharmaceutical Container Closure Integrity Testing Checklist
Ensure product sterility and shelf-life compliance. This checklist streamlines your container closure integrity testing, minimizing risk and maximizing confidence in your pharmaceutical packaging.
Test Planning & Preparation
Ensuring proper test scope, methodology selection, and equipment readiness.
Test Objective(s)
Test Methodology
Sample Size (Units)
Planned Test Start Date
Planned Test End Date
Acceptance Criteria Source
Equipment Calibration & Verification
Confirming accuracy and reliability of testing equipment.
Last Calibration Date
Calibration Frequency (in months)
Temperature Reading During Calibration (°C)
Pressure Reading During Calibration (PSI)
Calibration Standard Used
Calibration Details/Comments (if 'Other' selected above)
Calibration Certificate (PDF)
Technician Signature
Sample Selection & Handling
Ensuring representative samples are selected and handled appropriately.
Number of Samples Selected
Sampling Method
Sample Collection Date
Sample Collection Time
Sample Collection Location
Sample Description (Appearance, Condition)
Container Type
Sample Collector Signature
Leak Testing Procedure Adherence
Verifying adherence to established leak testing protocols (e.g., vacuum decay, pressure decay, helium leak testing).
Leak Testing Method
Vacuum Level (mmHg)
Pressure (psi)
Leak Rate Limit (cc/min)
Test Duration (minutes)
Specific Procedure Steps Followed (Detailed)
Procedure Version Used
Operator Signature
Data Acquisition & Recording
Accurate and complete recording of test data and observations.
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)
Operator Signature
Results Evaluation & Acceptance Criteria
Comparison of results against predetermined acceptance criteria and assessment of container closure integrity.
Leak Rate (ml/min)
Vacuum Decay Constant (k-value)
Method Used (e.g., Vacuum Decay, Pressure Decay, Helium)
Detailed Result Commentary
Pass/Fail Determination
Justification for Pass/Fail Determination
Date of Result Evaluation
Evaluator Signature
Deviation Management & Investigation
Documentation and investigation of any deviations from expected results or acceptance criteria.
Detailed Description of Deviation
Date of Deviation Occurrence
Time of Deviation Occurrence
Severity Level (e.g., Minor, Moderate, Major)
Quantity Affected (if applicable)
Root Cause Analysis
Corrective Action Plan
Corrective Action Completion Date
Investigator Signature
Report Generation & Review
Compilation of test results and conclusions into a comprehensive report for review and approval.
Executive Summary of Findings
Number of Containers Tested
Number of Failed Containers
Overall Conclusion (Pass/Fail/Conditional)
Detailed Description of Anomalies (if any)
Report Issue Date
Reviewer Signature
Supporting Data/Graphs (optional)
Maintenance and Cleaning of Equipment
Ensuring equipment is properly maintained and cleaned after testing.
Last Cleaning Date
Cleaning Procedure Followed (Detailed Description)
Cleaning Solution Concentration (%)
Areas Cleaned (Check all that apply)
Cleaning Verification Photos (Optional)
Cleaning Effectiveness Verification Method
Other Method Description (if selected)
Documentation Review and Traceability
Review of all associated documentation for completeness and traceability.
Document Review Date
Summary of Document Review Findings
Document Status
Document Revision Number
Upload Reviewed Document (if revised)
Reviewer Signature
Associated Batch/Lot Number
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Pharmaceutical Cleaning Deviation Investigation Checklist
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Pharmaceutical CAPA Management Checklist
Pharmaceutical Deviation Trend Analysis Checklist
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