Standard Operating Procedure for Rheological Testing in Gels
1) Purpose
The purpose of this SOP is to establish procedures for rheological testing of gels in the pharmaceutical industry to assess their flow properties and consistency.
2) Scope
This SOP applies to all personnel involved in rheological testing of gels within the pharmaceutical production facility.
3) Responsibilities
Quality Control (QC) Supervisor: Oversee rheological testing procedures as per this SOP.
QC Analysts: Perform rheological tests and record results accurately.
Production Operators: Provide gel samples and support as required for rheological testing.
4) Procedure
4.1 Sample Preparation
4.1.1 Ensure gel samples are prepared and equilibrated to testing temperature.
4.1.2 Mix samples gently to ensure homogeneity without introducing air bubbles.
4.2 Instrument Setup
4.2.1 Verify and calibrate the rheometer according to manufacturer instructions.
4.2.2 Set appropriate parameters (e.g., temperature, shear rate) for the rheological measurements.
4.3 Rheological Measurement
4.3.1 Place the gel sample on the rheometer stage or container.
4.3.2 Initiate the rheological measurement (e.g., viscosity, shear stress) as per the testing protocol.
4.3.3 Record rheological data including viscosity curves, shear stress vs. shear rate, etc.
4.4 Data Analysis
4.4.1 Analyze rheological data to determine flow behavior (e.g., Newtonian, non-Newtonian) and consistency.
4.4.2 Compare rheological parameters against acceptance criteria or specifications.
4.5 Cleaning and Maintenance
4.5.1 Clean the rheometer and accessories thoroughly after each use.
4.5.2 Perform regular maintenance and calibration of the rheometer as per schedule.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
– Rheological Test Reports
– Calibration Certificates
– Equipment Cleaning and Maintenance Logs
– SOP for Rheological Testing
7) Reference, if any
– USP <912> Rotational Viscometers
– Pharmacopoeial guidelines for rheological testing of pharmaceuticals
– Manufacturer’s instructions for rheometer operation and calibration
8) SOP Version
Version 1.0