Standard Operating Procedure for Homogenizer/Emulsifier Operation

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the safe and efficient operation of the homogenizer/emulsifier used in the formulation of cutaneous products. It aims to ensure that the equipment is operated correctly, producing high-quality emulsions and homogenized mixtures while adhering to regulatory requirements and safety standards.

Scope

This SOP applies to all personnel involved in the operation of the homogenizer/emulsifier for the formulation, manufacturing, and processing of creams, ointments, gels, and other cutaneous formulations.

Responsibilities

• Production Operators: Responsible for operating the homogenizer/emulsifier according to this SOP and ensuring that proper procedures are followed.
• Quality Assurance (QA): Responsible for verifying the quality of the emulsions and homogenized mixtures produced and ensuring compliance with regulatory requirements.
• Engineering Department: Responsible for maintaining and calibrating the homogenizer/emulsifier to ensure optimal performance.
• Supervisors: Responsible for overseeing the operation of the equipment, ensuring that it is properly maintained, and providing necessary resources.

Procedure

1. Preparation: Ensure that the homogenizer/emulsifier is clean, sanitized, and properly assembled before use.
2. Setup: Adjust the speed and other parameters of the equipment according to the formulation requirements.
3. Ingredient Addition: Add the ingredients to the mixing vessel of the equipment according to the formulation instructions.
4. Homogenization/Emulsification: Start the homogenization/emulsification process and gradually increase the speed to achieve the desired particle size and distribution.
5. Monitoring: Monitor the process parameters such as temperature, pressure, and speed to ensure proper homogenization/emulsification.
6. Sampling: Take samples at regular intervals to check the homogeneity and stability of the emulsion/homogenized mixture.
7. Adjustment: Make any necessary adjustments to the process parameters based on the sampling results to optimize product quality.
8. Cleaning: Thoroughly clean and sanitize the equipment after use to prevent cross-contamination between batches.
9. Documentation: Record all operation and cleaning activities in the equipment logbook, including process parameters, sampling results, and cleaning procedures.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance

Documents

• Equipment logbook
• Batch production record
• Cleaning log
• Sampling and testing records

Reference

Refer to manufacturers instruction related to homogenizers/emulsifiers

SOP Version

Version 1.0