Procedure for Extrudability Testing in Ointments

1) Purpose

The purpose of this SOP is to outline the procedure for evaluating the extrudability of ointments to ensure ease of dispensing and product quality.

2) Scope

This SOP applies to all ointment formulations manufactured within the facility that require extrudability testing as part of quality control.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting extrudability testing and ensuring compliance with this SOP.
Production Department: Responsible for providing ointment samples and supporting QC during testing.

4) Procedure

4.1 Sample Preparation:
    4.1.1 Obtain representative samples of ointments from different batches.
    4.1.2 Allow the ointment samples to equilibrate to room temperature before testing.
    4.1.3 Remove any protective seals or covers from the ointment containers.

4.2 Test Setup:
    4.2.1 Select a suitable extrusion apparatus (e.g., syringe, tube) based on the ointment packaging.
    4.2.2 Attach an appropriate dispensing tip or nozzle to the extrusion apparatus.
    4.2.3 Prime the apparatus with ointment to remove air and ensure proper flow.

4.3 Extrudability Testing:
    4.3.1 Position the extrusion apparatus vertically with the dispensing tip pointing downwards.
    4.3.2 Actuate the plunger or mechanism to dispense a specified amount of ointment.
    4.3.3 Observe the ease of ointment extrusion, consistency of flow, and any resistance encountered.
    4.3.4 Repeat the extrudability test with additional samples as needed to confirm consistency.

4.4 Evaluation:
    4.4.1 Assess extrudability based on the ability to dispense the ointment smoothly and completely without excessive force.
    4.4.2 Record qualitative observations such as plunger movement, flow rate, 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 Ointments are considered acceptable if they demonstrate easy extrudability without blockage or inconsistent flow.
    4.5.2 Ensure all extrudability testing adheres to validated procedures and method validation parameters.

4.6 Documentation:
    4.6.1 Record all extrudability testing procedures, results, and observations in the Extrudability 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

Extrudability Testing Report
Sampling Plan Document
Equipment Calibration Certificates

7) Reference, if any

USP General Chapter <1163> – Quality Assurance in Pharmaceutical Compounding
Pharmacopeial standards for Extrudability Testing in Ointments

8) SOP Version

Version 1.0