Standard Operating Procedure for Rheological Testing in Cream Manufacturing

1) Purpose

The purpose of this SOP is to outline the steps required for rheological testing of creams in a pharmaceutical manufacturing setting to assess their flow properties and consistency.

2) Scope

This SOP applies to all personnel involved in rheological testing of creams within the pharmaceutical production facility. It covers procedures for sample preparation, instrument setup, and rheological measurements.

3) Responsibilities

It is the responsibility of the quality control (QC) team to follow this SOP accurately and ensure that all rheological tests comply with GMP standards. The QC supervisor is responsible for overseeing the rheological testing process and ensuring proper documentation.

4) Procedure

4.1 Equipment Setup

4.1.1 Ensure that the rheometer or viscometer is clean and calibrated according to the manufacturer’s instructions.

4.1.2 Verify that the temperature control and other parameters (e.g., shear rate, shear stress) are set according to the method validation protocol.

4.2 Sample Preparation

4.2.1 Allow the cream sample to equilibrate to room temperature if stored under refrigerated conditions.

4.2.2 Mix the sample thoroughly to ensure homogeneity.

4.2.3 Transfer an appropriate amount of cream sample onto the rheometer plate or into the viscometer cell.

4.3 Rheological Measurement

4.3.1 Start the rheometer or viscometer and set the appropriate measurement