Procedure for Blister Pack Integrity Testing
1) Purpose
The purpose of this SOP is to outline the procedure for testing the integrity of blister packs used for packaging pharmaceutical products to ensure they meet quality and safety standards.
2) Scope
This SOP applies to all blister packs used for packaging pharmaceutical products, requiring testing to comply with regulatory requirements and internal specifications regarding packaging integrity.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing blister pack integrity testing.
Quality Assurance (QA) Department: Responsible for review and approval of testing procedures and results.
Manufacturing Department: Responsible for providing blister packs and support during testing.
4) Procedure
4.1 Sample Selection:
4.1.1 Select representative blister packs from current production batches.
4.1.2 Ensure samples include different pack sizes and configurations.
4.2 Visual Inspection:
4.2.1 Inspect each blister pack visually for defects such as punctures, tears, or incomplete seals.
4.2.2 Document observations and categorize defects according to predefined criteria.
4.3 Seal Integrity Testing:
4.3.1 Perform seal integrity testing using appropriate methods (e.g., dye penetration, burst strength, vacuum decay).
4.3.2 Conduct testing under controlled conditions and record test parameters and results accurately.
4.4 Peelability Testing:
4.4.1 Evaluate the ease and consistency of blister pack opening to ensure product protection and user convenience.
4.5 Compatibility Testing:
4.5.1 Verify compatibility of blister pack materials with pharmaceutical products to prevent interaction or degradation.
4.5.2 Perform testing under simulated storage conditions (e.g., temperature, humidity).
4.6 Data Analysis:
4.6.1 Compile and analyze test data, including visual inspection results, seal integrity tests, peelability testing, and compatibility assessments.
4.6.2 Review data against acceptance criteria and regulatory standards.
4.7 Reporting:
4.7.1 Prepare a Blister Pack Integrity Testing Report summarizing test procedures, results, and conclusions.
4.7.2 Include recommendations for improvements or corrective actions based on test findings.
4.7.3 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
6) Documents, if any
Blister Pack Integrity Testing Report
Visual Inspection Records
Seal Integrity Testing Data
Peelability Testing Results
7) Reference, if any
USP Chapter 1216 – Pharmaceutical Dosage Forms: Tablet and Capsule Dissolution Testing
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0