Procedure for Syringe Plunger Force Testing

1) Purpose

The purpose of this SOP is to outline the procedure for testing the plunger force of syringes used for packaging pharmaceutical products to ensure proper functionality and safety.

2) Scope

This SOP applies to all syringes used for packaging pharmaceutical products, requiring testing to comply with regulatory requirements and internal specifications regarding plunger force.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing syringe plunger force testing.
Quality Assurance (QA) Department: Responsible for review and approval of testing procedures and results.
Manufacturing Department: Responsible for providing syringes and support during testing.

4) Procedure

4.1 Sample Selection:
    4.1.1 Select representative syringes from current production batches.
    4.1.2 Ensure samples include different syringe sizes and configurations.

4.2 Equipment Setup:
    4.2.1 Calibrate the testing equipment (e.g., force gauge) as per manufacturer’s instructions.
    4.2.2 Verify the stability and accuracy of the equipment setup before testing.

4.3 Plunger Force Measurement:
    4.3.1 Attach the syringe to the force gauge and position the plunger appropriately.
    4.3.2 Apply a controlled force to the plunger and measure the peak force required to move the plunger.

4.4 Repeat Testing:
    4.4.1 Perform multiple measurements for each syringe to ensure consistency and accuracy.
    4.4.2 Record all measurements and calculate the average