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 parameters (e.g., shear rate ramp, oscillation frequency).
4.3.2 Record the rheological data, including viscosity, shear stress, shear rate, and other relevant parameters depending on the instrument and test method.
4.3.3 Perform multiple measurements or runs as necessary to obtain consistent results.
4.4 Data Analysis and Acceptance Criteria
4.4.1 Analyze the rheological data to assess flow behavior, viscosity profile, and consistency parameters (e.g., yield stress, viscosity at different shear rates).
4.4.2 Compare the rheological parameters against the specified acceptance criteria defined in the product specification or regulatory guidelines.
4.4.3 Record all rheological test results in the batch record and electronic database.
4.5 Cleaning and Maintenance
4.5.1 Clean the rheometer or viscometer after each use according to the cleaning SOP to prevent cross-contamination.
4.5.2 Perform routine maintenance and calibration of the rheometer or viscometer as per the manufacturer’s instructions and 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)
Rheological Testing Report
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
USP (United States Pharmacopeia) General Chapter 914: Rheology
8) SOP Version
Version 1.0
