Standard Operating Procedure for Use of Thickeners in Gels Production

1) Purpose

The purpose of this SOP is to define the procedures for selecting, handling, and incorporating thickeners in gel formulations to ensure consistent product quality and viscosity.

2) Scope

This SOP applies to all personnel involved in the production of gels using thickeners within the pharmaceutical manufacturing facility.

3) Responsibilities

Formulation Scientists: Select appropriate thickeners and provide guidance on their use.
Production Operators: Handle and incorporate thickeners according to this SOP.
Quality Control (QC) Analysts: Test the viscosity and quality of gels containing thickeners.
Quality Assurance (QA) Team: Review and approve procedures and results related to the use of thickeners.

4) Procedure

4.1 Selection of Thickeners
4.1.1 Choose thickeners based on desired properties such as viscosity, compatibility with other ingredients, and stability.
4.1.2 Ensure selected thickeners comply with regulatory requirements and product specifications.

4.2 Handling of Thickeners
4.2.1 Store thickeners in a cool, dry place according to manufacturer’s recommendations.
4.2.2 Use appropriate personal protective equipment (PPE) when handling thickeners.

4.3 Incorporation of Thickeners
4.3.1 Weigh the required amount of thickener accurately using a calibrated balance.
4.3.2 Gradually add the thickener to the formulation while stirring continuously to prevent clumping.
4.3.3 Continue stirring until the thickener is fully dispersed and the desired viscosity is achieved.

4.4 Quality Control Testing
4.4.1 Test the viscosity and homogeneity of the gel to ensure proper incorporation of the thickener.
4.4.2 Conduct stability testing to verify that the gel maintains its properties over time.

4.5 Documentation
4.5.1 Record batch numbers, quantities, and lot numbers of thickeners used in production.
4.5.2 Maintain records of QC tests and stability studies.

5) Abbreviations, if any

SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

– Batch Production Records
– QC Testing Records
– Stability Testing Reports

7) Reference, if any

– USP General Chapter <911> Viscosity
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– Company-specific guidelines on the use of thickeners

8) SOP Version

Version 1.0