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 and record the viscosity reading after stabilization, typically after 30 seconds.

4.3.3 Repeat the measurement at least three times for each sample and calculate the average viscosity.

4.4 Data Analysis and Acceptance Criteria

4.4.1 Compare the viscosity measurements against the specified acceptance criteria defined in the product specification or regulatory guidelines.

4.4.2 Record all viscosity test results in the batch record and electronic database.

4.4.3 Document any deviations from the acceptance criteria and notify the QC supervisor for further investigation.

4.5 Cleaning and Maintenance

4.5.1 Clean the viscosity testing equipment after each use according to the cleaning SOP to prevent cross-contamination.

4.5.2 Perform routine maintenance and calibration of the viscometer and spindle as per the maintenance schedule.

4.5.3 Record all cleaning and maintenance activities in the equipment logbook.

5) Abbreviations, if any

GMP: Good Manufacturing Practices

QC: Quality Control

6) Documents, if any

Batch Manufacturing Record (BMR)

Viscosity Testing Logbook

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

USP (United States Pharmacopeia) General Chapter 785: Viscosity

8) SOP Version

Version 1.0