Procedure for Container-Closure System Testing
1) Purpose
The purpose of this SOP is to outline the procedure for testing container-closure systems used for pharmaceutical products to ensure integrity and suitability for maintaining product quality and safety.
2) Scope
This SOP applies to all container-closure systems (e.g., vials, bottles, ampoules) used for packaging pharmaceutical products, requiring testing to comply with regulatory requirements and internal specifications.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing container-closure system testing.
Quality Assurance (QA) Department: Responsible for review and approval of testing procedures and results.
Manufacturing Department: Responsible for providing samples and support during testing.
4) Procedure
4.1 Sample Selection:
4.1.1 Select representative samples of container-closure systems for testing.
4.1.2 Ensure samples are from current production batches and include various sizes and configurations.
4.2 Visual Inspection:
4.2.1 Inspect each container-closure system visually for defects such as cracks, chips, or visible contamination.
4.2.2 Record observations and categorize defects according to predefined criteria.
4.3 Dimensional Testing:
4.3.1 Measure critical dimensions of the container-closure systems (e.g., inner diameter, height, closure dimensions).
4.3.2 Compare measurements against specification limits to ensure dimensional accuracy.
4.4 Closure Integrity Testing:
4.4.1 Conduct closure integrity testing using appropriate methods (e.g., dye ingress, vacuum decay, microbial challenge).
4.4.2 Perform testing under controlled
4.5 Extractables and Leachables Testing:
4.5.1 Collect samples from container-closure systems for extractables testing.
4.5.2 Analyze extracted samples for potential leachables using suitable analytical techniques (e.g., GC-MS, LC-MS).
4.6 Performance Testing:
4.6.1 Evaluate container-closure system performance under simulated transportation and storage conditions.
4.6.2 Assess functionalities such as seal integrity, ease of opening, and closure strength.
4.7 Data Analysis:
4.7.1 Compile and analyze test data, including visual inspection results, dimensional measurements, closure integrity tests, and extractables/leachables data.
4.7.2 Review data against acceptance criteria and regulatory standards.
4.8 Reporting:
4.8.1 Prepare a Container-Closure System Testing Report summarizing test procedures, results, and conclusions.
4.8.2 Include recommendations for improvements or corrective actions if any deviations are identified.
4.8.3 Submit the report to QA for review and approval and maintain records as per facility procedures.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
GC-MS: Gas Chromatography-Mass Spectrometry
LC-MS: Liquid Chromatography-Mass Spectrometry
6) Documents, if any
Container-Closure System Testing Report
Dimensional Measurement Records
Closure Integrity Testing Data
Extractables and Leachables Analysis Reports
7) Reference, if any
USP Chapter 1207 – Container Closure Integrity Testing for Parenteral Products
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0
