Procedure for Spreadability Testing in Semisolids

1) Purpose

The purpose of this SOP is to outline the procedure for testing the spreadability of semisolid pharmaceutical formulations to assess their ease of application and consistency.

2) Scope

This SOP applies to all semisolid formulations (e.g., creams, ointments, gels) manufactured within the facility that require spreadability testing as part of quality control.

3) Responsibilities

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

4) Procedure

4.1 Equipment Setup:
    4.1.1 Prepare a flat, smooth surface for testing (e.g., glass plate) cleaned and dried thoroughly.
    4.1.2 Ensure the room temperature and humidity are controlled to minimize environmental effects on testing.
    4.1.3 Calibrate any equipment used for measurement (e.g., ruler, stopwatch) according to validated procedures.

4.2 Sample Preparation:
    4.2.1 Obtain representative samples of semisolid formulations from different batches.
    4.2.2 Allow samples to equilibrate to room temperature before testing.
    4.2.3 Remove any air bubbles or surface irregularities from the sample surface.

4.3 Spreadability Testing:
    4.3.1 Place a specified amount of the semisolid sample onto the prepared surface.
    4.3.2 Use a standard weight or apparatus (e.g., spatula) to apply controlled pressure while spreading the