Procedure for Syringeability Testing in Injectables
1) Purpose
The purpose of this SOP is to outline the procedure for evaluating the syringeability of injectable pharmaceutical products to ensure ease of administration and product quality.
2) Scope
This SOP applies to all injectable pharmaceutical products manufactured within the facility that require syringeability testing as part of quality control.
3) Responsibilities
Quality Control (QC) Department: Responsible for conducting syringeability testing and ensuring compliance with this SOP.
Production Department: Responsible for providing injectable samples and supporting QC during testing.
4) Procedure
4.1 Sample Preparation:
4.1.1 Obtain representative samples of injectable products from different batches.
4.1.2 Ensure samples are stored and handled according to specified storage conditions.
4.1.3 Remove any protective caps or seals from the syringe and needle assembly.
4.2 Syringe Preparation:
4.2.1 Attach a suitable gauge needle to a sterile syringe appropriate for the sample volume.
4.2.2 Prime the syringe and needle assembly with the injectable sample following aseptic techniques.
4.2.3 Ensure the syringe is filled with the appropriate volume of sample without introducing air bubbles.
4.3 Syringeability Testing:
4.3.1 Position the filled syringe vertically with the needle tip pointing upwards.
4.3.2 Actuate the syringe plunger smoothly and steadily to expel the sample through the needle.
4.3.3 Observe the ease of sample expulsion, resistance encountered, and any tendency for blockage or leakage.
4.3.4 Repeat the syringeability test with additional syringes as needed to confirm consistency.
4.4 Evaluation:
4.4.1 Assess syringeability based on the ability to expel the sample smoothly and completely without excessive force.
4.4.2 Record qualitative observations such as plunger movement, resistance, and any deviations from expected behavior.
4.4.3 Use subjective grading scales or quantitative measures (e.g., force required, time taken) if applicable.
4.5 Acceptance Criteria:
4.5.1 Injectable products are considered acceptable if they demonstrate easy syringeability without plunger blockage or leakage.
4.5.2 Ensure all syringeability testing adheres to validated procedures and method validation parameters.
4.6 Documentation:
4.6.1 Record all syringeability testing procedures, results, and observations in the Syringeability Testing Report.
4.6.2 Maintain detailed records of sample details, testing conditions, equipment used, and any deviations noted.
4.6.3 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Syringeability Testing Report
Sampling Plan Document
Equipment Calibration Certificates
7) Reference, if any
USP General Chapter <1> – Injections
Pharmacopeial standards for Syringeability Testing in Injectables
8) SOP Version
Version 1.0
