Standard Operating Procedure for Use of Thickeners in Creams Production
1) Purpose
The purpose of this SOP is to define the procedures for the selection and incorporation of thickeners in creams production to achieve the desired viscosity and texture of the final product.
2) Scope
This SOP applies to all personnel involved in the formulation, manufacturing, and quality control of creams, including formulation scientists, production operators, and quality assurance (QA) personnel. It covers the procedures for thickener selection, addition, and documentation.
3) Responsibilities
It is the responsibility of formulation scientists to select suitable thickeners based on formulation requirements, production operators to accurately weigh and incorporate thickeners into the formulation, and QA personnel to verify compliance with specifications.
4) Procedure
4.1 Selection of Thickeners
4.1.1 Refer to the formulation development report or master formula to identify the recommended thickeners and their concentration ranges.
4.1.2 Evaluate the compatibility of thickeners with other formulation components (e.g., emulsifiers, stabilizers).
4.1.3 Choose thickeners based on their rheological properties (e.g., viscosity enhancement, shear thinning behavior) and compatibility with the cream formulation.
4.2 Preparation for Thickener Addition
4.2.1 Review the batch record and formulation worksheet to determine the amount of thickener required for the batch.
4.2.2 Ensure all equipment (e.g., scales, mixing vessels) is clean, calibrated, and suitable for handling thickeners.
4.2.3 Wear appropriate personal protective equipment (PPE) such as gloves and lab coat during thickener handling to prevent skin contact and inhalation.
4.3 Addition of Thickeners
4.3.1 Weigh the specified amount of thickener accurately using a calibrated scale.
4.3.2 Add the thickener to the cream formulation according to the formulation instructions, ensuring gradual and uniform dispersion.
4.3.3 Use gentle mixing or stirring to incorporate the thickener into the formulation without introducing air bubbles.
4.4 Mixing and Homogenization
4.4.1 Mix or homogenize the cream formulation thoroughly to achieve even distribution of the thickener and uniform viscosity.
4.4.2 Adjust mixing parameters (e.g., speed, duration) to optimize thickener dispersion and ensure consistent product quality.
4.5 Quality Control
4.5.1 Perform viscosity testing to verify the effectiveness of the thickener in achieving the desired cream viscosity.
4.5.2 Conduct stability testing (e.g., centrifugation, temperature cycling) to assess the robustness of the cream formulation.
4.5.3 Monitor pH levels to ensure the cream formulation remains within specified stability limits.
4.6 Documentation and Review
4.6.1 Document all details of thickener selection, addition, and processing in the batch record or formulation worksheet.
4.6.2 Review the thickener addition procedure and quality control results to ensure compliance with formulation specifications.
4.6.3 Submit the batch documentation for review and approval by QA personnel before further processing or packaging.
5) Abbreviations, if any
QA: Quality Assurance
PPE: Personal Protective Equipment
SOP: Standard Operating Procedure
6) Documents, if any
Formulation Development Report
Master Formula Record
Batch Record
Formulation Worksheet
7) Reference, if any
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
USP (United States Pharmacopeia) General Chapter on Viscosity of Non-Newtonian Liquids
8) SOP Version
Version 1.0