Standard Operating Procedure for Packaging Integrity Testing
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting packaging integrity testing of pharmaceutical products, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure that the packaging provides adequate protection to the product.
2) Scope
This SOP applies to all personnel involved in the packaging integrity testing of pharmaceutical products within the pharmaceutical manufacturing facility. It covers the procedures for sample preparation, testing, and data analysis.
3) Responsibilities
– Quality Control (QC) Department: Responsible for conducting packaging integrity tests and recording data.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Production Department: Provides samples for packaging integrity testing as per the testing protocol.
4) Procedure
4.1 Sample Collection
4.1.1 Collect representative samples of the packaged product as per the sampling plan.
4.1.2 Ensure samples are properly labeled with batch number and packaging date.
4.2 Testing Methods
4.2.1 Select the appropriate method for packaging integrity testing, such as vacuum decay, bubble emission, or dye penetration tests.
4.2.2 Ensure that all testing equipment is calibrated and maintained according to manufacturer’s instructions.
4.3 Vacuum Decay Test
4.3.1 Place the sample in the vacuum chamber and evacuate air
4.3.2 Monitor the chamber for any increase in pressure that would indicate a leak.
4.3.3 Record the results and identify any samples that fail the test.
4.4 Bubble Emission Test
4.4.1 Submerge the sample in water and apply internal pressure.
4.4.2 Observe the sample for the emission of bubbles, which indicates a leak.
4.4.3 Record the results and identify any samples that fail the test.
4.5 Dye Penetration Test
4.5.1 Apply a dye solution to the outside of the package.
4.5.2 Inspect the interior of the package for any dye penetration that indicates a breach in integrity.
4.5.3 Record the results and identify any samples that fail the test.
4.6 Data Analysis
4.6.1 Analyze the test results to determine if the packaging meets predefined specifications.
4.6.2 Investigate any samples that fail to identify the root cause of the breach in integrity.
4.7 Documentation
4.7.1 Document all test results, including observations and measurements, in the packaging integrity testing logbook or electronic database.
4.7.2 Ensure that all records are reviewed and approved by the QC department.
4.8 Reporting
4.8.1 Prepare a packaging integrity testing report summarizing the methodology, results, and any deviations observed.
4.8.2 Submit the report to the QA department for review and approval.
4.9 Corrective Actions
4.9.1 If packaging integrity is compromised, initiate an investigation to identify the source of the problem.
4.9.2 Implement corrective actions as necessary and document all findings and actions taken.
5) Abbreviations, if any
– IM: Intramuscular
– SC: Subcutaneous
– QC: Quality Control
– QA: Quality Assurance
6) Documents, if any
– Packaging Integrity Testing Logbook
– Packaging Integrity Testing Reports
– Batch Records
7) Reference, if any
– USP <1207> Package Integrity Evaluation – Sterile Products
– ASTM F2338-09(2013) Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
8) SOP Version
Version 1.0