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 plunger force for each syringe.
4.5 Acceptance Criteria:
4.5.1 Compare measured plunger forces against predefined acceptance criteria.
4.5.2 Reject syringes that do not meet specified force requirements and document deviations.
4.6 Reporting:
4.6.1 Prepare a Syringe Plunger Force Testing Report summarizing test procedures, results, and conclusions.
4.6.2 Include recommendations for improvements or corrective actions based on test findings.
4.6.3 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
Syringe Plunger Force Testing Report
Equipment Calibration Records
Plunger Force Measurement Data
7) Reference, if any
ISO 7886-1:2017 – Sterile hypodermic syringes for single use
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0