Standard Operating Procedure for Viscosity Testing in Cream Manufacturing

1) Purpose

The purpose of this SOP is to outline the steps required for viscosity testing of creams in a pharmaceutical manufacturing setting to ensure consistency and quality control of the product’s viscosity.

2) Scope

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

3) Responsibilities

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

4) Procedure

4.1 Equipment Setup

4.1.1 Ensure that the viscometer and spindle are clean and calibrated according to the manufacturer’s instructions.

4.1.2 Verify that the temperature of the viscosity testing area is within the specified range (typically 25 ± 1°C).

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 into the viscosity cup.

4.3 Viscosity Measurement

4.3.1 Lower the spindle into the cream sample until it is fully immersed.

4.3.2 Start the viscometer