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:
    4.4.1 Test safety mechanisms (e.g., needle retraction) to ensure proper operation and user safety.