Standard Operating Procedure for Viscosity Testing
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting viscosity testing of pharmaceutical formulations, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure consistency and appropriate flow characteristics of the product.
2) Scope
This SOP applies to all personnel involved in the viscosity testing of pharmaceutical formulations within the pharmaceutical manufacturing facility. It covers the procedures for sample preparation, measurement, and data analysis.
3) Responsibilities
– Quality Control (QC) Department: Responsible for performing viscosity tests and recording data.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Production Department: Provides samples for viscosity testing as per the testing protocol.
4) Procedure
4.1 Equipment and Materials
4.1.1 Ensure that the viscometer or rheometer is calibrated and maintained.
4.1.2 Prepare all necessary materials, including samples, solvents, and any required accessories.
4.2 Sample Preparation
4.2.1 Obtain representative samples of the formulation as per the sampling plan.
4.2.2 Ensure that samples are homogenous and free of air bubbles before testing.
4.3 Measurement
4.3.1 Set up the viscometer or rheometer according to the manufacturer’s instructions.
4.3.2 Load the prepared sample into the viscometer or rheometer.
4.3.3 Perform the viscosity measurement at the specified temperature and shear rate.
4.3.4 Record the viscosity data.
4.4 Data Analysis
4.4.1 Analyze the viscosity data to determine if the formulation meets the predefined specifications.
4.4.2 Compare the results with historical data to ensure consistency.
4.5 Documentation
4.5.1 Document all measurement data, including raw data and calculated parameters, in the viscosity testing logbook or electronic database.
4.5.2 Ensure that all records are reviewed and approved by the QC department.
4.6 Reporting
4.6.1 Prepare a viscosity testing report summarizing the methodology, results, and any observations.
4.6.2 Submit the report to the QA department for review and approval.
4.7 Troubleshooting
4.7.1 If the results do not meet specifications, investigate potential causes such as equipment malfunction or sample preparation errors.
4.7.2 Repeat the analysis if necessary, following corrective actions.
5) Abbreviations, if any
– IM: Intramuscular
– SC: Subcutaneous
– QC: Quality Control
– QA: Quality Assurance
6) Documents, if any
– Viscosity Testing Logbook
– Calibration Records
– Viscosity Testing Reports
7) Reference, if any
– USP <911> Viscosity
– ISO 3104:1994 Petroleum Products – Transparent and Opaque Liquids – Determination of Kinematic Viscosity and Calculation of Dynamic Viscosity
8) SOP Version
Version 1.0
