Standard Operating Procedure for Use of Emulsifiers in Creams Production
1) Purpose
The purpose of this SOP is to outline the procedures for the selection and use of emulsifiers in creams production to ensure stable emulsion formation and product quality.
2) Scope
This SOP applies to all personnel involved in the formulation and production of creams, including formulation scientists, production operators, and quality assurance (QA) personnel. It covers procedures for emulsifier selection, addition, and documentation.
3) Responsibilities
It is the responsibility of formulation scientists to select suitable emulsifiers, production operators to accurately weigh and incorporate emulsifiers into the cream formulation, and QA personnel to verify compliance with specifications.
4) Procedure
4.1 Selection of Emulsifiers
4.1.1 Refer to the formulation development report or master formula to identify the recommended emulsifiers and their concentration ranges.
4.1.2 Evaluate the compatibility of emulsifiers with other formulation components (e.g., oils, water phase, active ingredients).
4.1.3 Choose emulsifiers based on their HLB (Hydrophilic-Lipophilic Balance) value and compatibility with the desired cream properties (e.g., texture, stability).
4.2 Preparation for Emulsifier Addition
4.2.1 Review the batch record and formulation worksheet to determine the amount of emulsifier required for the batch.
4.2.2 Ensure all equipment (e.g., scales, mixing vessels) is clean, calibrated, and suitable for emulsifier
4.2.3 Wear appropriate personal protective equipment (PPE) such as gloves and lab coat during emulsifier handling to prevent skin contact and inhalation.
4.3 Addition of Emulsifiers
4.3.1 Weigh the specified amount of emulsifier accurately using a calibrated scale.
4.3.2 Add the emulsifier to the designated phase (e.g., oil phase, water phase) according to the formulation instructions.
4.3.3 Use gentle mixing or stirring to ensure uniform dispersion of the emulsifier in the phase without introducing air bubbles.
4.4 Homogenization or Mixing
4.4.1 Homogenize or mix the emulsifier-containing phase with other formulation components using appropriate equipment (e.g., homogenizer, overhead stirrer).
4.4.2 Control the mixing speed and duration to achieve a homogeneous cream emulsion without phase separation or instability.
4.5 Quality Control
4.5.1 Perform visual inspection and viscosity testing of the emulsion to verify uniform emulsification and consistency.
4.5.2 Conduct pH testing to ensure the emulsion is within the specified range for stability and skin compatibility.
4.5.3 Sample the batch for further testing and analysis according to the batch record and quality control plan.
4.6 Documentation and Review
4.6.1 Document all details of emulsifier selection, addition, and processing in the batch record or formulation worksheet.
4.6.2 Review the emulsifier 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
HLB: Hydrophilic-Lipophilic Balance
SOP: Standard Operating Procedure
6) Documents, if any
Formulation Development Report
Master Formula Record
Batch Record
Formulation Worksheet
7) Reference, if any
ICH Q8(R2): Pharmaceutical Development
USP (United States Pharmacopeia) General Chapter on Emulsions
8) SOP Version
Version 1.0