syringe leakage, needle attachment, and injection force.

2. Scope

This SOP is applicable to all Quality Control (QC), Quality Assurance (QA), and Manufacturing departments involved in the inspection, testing, and release of prefilled syringes intended for sterile injectable use. It applies to both in-process samples and finished products.

3. Responsibilities

• QC Analyst: Responsible for conducting the functional tests and recording observations accurately.
• QA Officer: Verifies results and ensures compliance with specifications and procedural adherence.
• Manufacturing Operator: Provides samples and information regarding production batches.
• Head QC: Reviews and approves testing protocols and reports.

4. Accountability

The Head of Quality Control is accountable for ensuring that all functional testing of prefilled syringes is performed and documented in compliance with applicable procedures and standards.

5. Procedure

5.1 Sample Collection

1. Collect representative samples from the beginning, middle, and end of each batch during or immediately after filling.
2. Samples should be randomly selected to ensure unbiased testing.
3. Record sample details in the Functional Testing Log (Annexure-1).

5.2 Equipment and Materials Required

• Digital force gauge
• Stopwatch
• Leakage test apparatus
• Micrometer or caliper (for dimensional checks)
• Syringe holders and test fixtures
• Safety gloves and protective gear

5.3 Functional Test Parameters

Each sample must undergo the following functional tests:

5.3.1 Plunger Functionality

1. Inspect the syringe for smooth plunger movement from end to end.
2. Pull the plunger rod completely and push back to confirm smooth motion and resistance.
3. Reject syringes with jerky movement or resistance beyond 10% deviation from standard force.

5.3.2 Injection Force Measurement

1. Place the syringe on the force gauge with the plunger aligned.
2. Apply force slowly and record the peak force required to expel the solution.
3. Injection force should not exceed 25 Newtons unless otherwise specified in product-specific guidelines.

5.3.3 Leak Test

1. Submerge the syringe in a water bath with an attached needle or cap.
2. Apply internal pressure of 3 psi and hold for 30 seconds.
3. Observe for any bubble formation indicating leakage.
4. Reject syringes showing evidence of leaks.

5.3.4 Needle or Cap Attachment Integrity

1. Test the strength of needle bonding or cap by applying a pull force.
2. The attachment should withstand a pull force of 10 Newtons without detachment.

5.3.5 Visual and Dimensional Inspection

1. Inspect each sample for visible cracks, air bubbles, overfilled or underfilled volumes.
2. Measure the external diameter and length of the syringe barrel and plunger.
3. Record deviations in the Dimensional Check Log (Annexure-2).

5.4 Documentation

• Each test must be documented in real-time.
• All observations, results, and analyst remarks must be recorded in the Functional Testing Report (Annexure-3).
• Deviation or failure must be reported immediately to QA and documented through a deviation report.

5.5 Acceptance Criteria

• All test parameters must meet specified limits for the lot to be considered acceptable.
• If one or more units fail, perform investigation and re-sampling as per QA guidelines.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• psi: Pounds per Square Inch
• Newton: Unit of force (N)

7. Documents

1. Functional Testing Log – Annexure-1
2. Dimensional Check Log – Annexure-2
3. Functional Testing Report – Annexure-3

8. References

• USP <1207> – Package Integrity Evaluation – Sterile Products
• ISO 11040 – Prefilled Syringes Requirements
• ICH Q6A – Specifications: Test Procedures and Acceptance Criteria

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QC Analyst	QA Executive	Head QA
Department	Quality Control	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Functional Testing Log

Batch No.	Sample ID	Date	Tested By	Remarks
PFS-22001	SMP-05	20/06/2025	Ritika Desai	Accepted

Annexure-2: Dimensional Check Log

Sample ID	Barrel Diameter (mm)	Plunger Length (mm)	Deviation	Status
SMP-05	12.05	85.00	Within Spec	Pass

Annexure-3: Functional Testing Report

Sample ID	Injection Force (N)	Leak Test	Plunger Test	Needle Integrity	Status
SMP-05	18.5	Pass	Pass	Pass	Accepted

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New Process Introduction	QA Head
24/06/2025	2.0	Added dimensional checks and leak test protocol	Annual SOP Review	QA Head