Procedure for Penetration Testing in Semisolids

1) Purpose

The purpose of this SOP is to outline the procedure for determining the penetration characteristics of semisolid pharmaceutical preparations to ensure product consistency and quality.

2) Scope

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

3) Responsibilities

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

4) Procedure

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

4.2 Test Setup:
    4.2.1 Select an appropriate penetration apparatus (e.g., penetrometer) based on the sample consistency and container type.
    4.2.2 Calibrate the penetrometer according to manufacturer instructions and ensure accuracy.
    4.2.3 Position the sample container under the penetrometer with the probe in contact with the surface of the semisolid.

4.3 Penetration Testing:
    4.3.1 Lower the penetrometer probe gently onto the semisolid surface until a specified depth or resistance is reached.
    4.3.2 Maintain the probe position for a specified duration to allow penetration measurement.
    4.3.3 Record the penetration depth or distance traveled by the probe accurately.
    4.3.4 Repeat the penetration test with additional samples as needed to confirm consistency.

4.4 Evaluation:
    4.4.1 Assess penetration characteristics based on the depth or distance traveled by the penetrometer probe.
    4.4.2 Record qualitative observations such as probe movement, sample resistance, and any deviations from expected behavior.
    4.4.3 Use subjective grading scales or quantitative measures (e.g., penetration force, time taken) if applicable.

4.5 Acceptance Criteria:
    4.5.1 Semisolid preparations are considered acceptable if they demonstrate consistent penetration characteristics within specified limits.
    4.5.2 Ensure all penetration testing adheres to validated procedures and method validation parameters.

4.6 Documentation:
    4.6.1 Record all penetration testing procedures, results, and observations in the Penetration 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

Penetration Testing Report
Sampling Plan Document
Penetrometer Calibration Certificates

7) Reference, if any

USP General Chapter <1724> – Pharmaceutical Water for Injection
Pharmacopeial standards for Penetration Testing in Semisolids

8) SOP Version

Version 1.0