Procedure for Pen Injector Functionality Testing
1) Purpose
The purpose of this SOP is to outline the procedure for testing the functionality of pen injectors used for administering pharmaceutical products to ensure proper operation and accuracy.
2) Scope
This SOP applies to all pen injectors used for administering pharmaceutical products, requiring testing to comply with regulatory requirements and internal specifications regarding functionality.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing pen injector functionality testing.
Quality Assurance (QA) Department: Responsible for review and approval of testing procedures and results.
Manufacturing Department: Responsible for providing pen injectors and support during testing.
4) Procedure
4.1 Sample Selection:
4.1.1 Select representative pen injectors from current production batches.
4.1.2 Ensure samples include different injector types and configurations.
4.2 Functionality Testing:
4.2.1 Prime the pen injector as per manufacturer’s instructions.
4.2.2 Perform simulated injections to verify functionality, including dose accuracy and needle deployment.
4.2.3 Record observations of injector performance and any deviations from expected behavior.
4.3 Dose Accuracy Verification:
4.3.1 Use a calibrated device to measure and verify the accuracy of dose delivery.
4.3.2 Compare delivered doses against intended doses and acceptance criteria.
4.4 Safety Mechanism Testing: 4.5 Compatibility Testing: 4.6 Data Analysis: 4.7 Reporting: QC: Quality Control Pen Injector Functionality Testing Report ISO 11608-1:2014 – Needle-based injection systems for medical use Version 1.0
4.4.1 Test safety mechanisms (e.g., needle retraction) to ensure proper operation and user safety.
4.5.1 Verify compatibility of pen injector materials with pharmaceutical products to prevent interaction or degradation.
4.5.2 Perform testing under simulated storage conditions (e.g., temperature, humidity).
4.6.1 Compile and analyze test data, including functionality test results, dose accuracy verification, safety mechanism testing, and compatibility assessments.
4.6.2 Review data against acceptance criteria and regulatory standards.
4.7.1 Prepare a Pen Injector Functionality 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
QA: Quality Assurance6) Documents, if any
Functionality Test Records
Dose Accuracy Verification Data7) Reference, if any
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics8) SOP Version
