Standard Operating Procedure for Viscosity Testing of Gels

1) Purpose

The purpose of this SOP is to establish procedures for viscosity testing of gels in the pharmaceutical industry to ensure consistency and quality control during production.

2) Scope

This SOP applies to all personnel involved in viscosity testing of gels within the pharmaceutical production facility.

3) Responsibilities

Quality Control (QC) Supervisor: Oversee viscosity testing procedures as per this SOP.
QC Analysts: Perform viscosity tests and record results accurately.
Production Operators: Provide gel samples and support as required for viscosity testing.

4) Procedure

4.1 Equipment Setup
4.1.1 Verify and calibrate the viscosity measuring instrument (e.g., viscometer) according to manufacturer instructions.
4.1.2 Prepare required accessories and standards for viscosity measurement.

4.2 Sample Preparation
4.2.1 Allow gel samples to equilibrate to room temperature before testing.
4.2.2 Mix samples gently to ensure homogeneity without introducing air bubbles.

4.3 Viscosity Measurement
4.3.1 Set the viscometer to the appropriate speed and spindle based on the viscosity range of the gel.
4.3.2 Immerse the spindle into the gel sample and start the measurement.
4.3.3 Record viscosity readings once stabilized and repeat measurements as necessary for accuracy.

4.4 Calculation and Recording
4.4.1 Calculate viscosity values using the appropriate formula or software provided by the manufacturer.
4.4.2 Record viscosity measurements in the designated QC records or electronic systems.

4.5 Data Analysis and Acceptance Criteria
4.5.1 Compare viscosity measurements against predefined acceptance criteria or specifications.
4.5.2 Identify and document any deviations from specified viscosity limits.

4.6 Cleaning and Maintenance
4.6.1 Clean the viscometer and accessories thoroughly after each use as per cleaning SOP.
4.6.2 Perform regular maintenance and calibration of the viscometer as per schedule.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

– Viscosity Test Reports
– Calibration Certificates
– Equipment Cleaning and Maintenance Logs
– SOP for Viscosity Testing

7) Reference, if any

– USP <911> Viscosity
– Pharmacopoeial guidelines for viscosity testing of pharmaceuticals
– Manufacturer’s instructions for viscometer operation and calibration

8) SOP Version

Version 1.0