Standard Operating Procedure for Homogenization in Cream Manufacturing
1) Purpose
The purpose of this SOP is to outline the steps required for the homogenization process in the production of creams in a pharmaceutical manufacturing setting to ensure uniformity, consistency, and compliance with regulatory standards.
2) Scope
This SOP applies to all personnel involved in the homogenization of creams within the pharmaceutical production facility. It covers the preparation, operation, and maintenance of the homogenization equipment.
3) Responsibilities
The purpose of SOP here
4) Procedure
4.1 Preparation of Equipment and Materials
4.1.1 Ensure that the homogenizer is clean, calibrated, and in good working condition.
4.1.2 Verify the availability of the cream pre-mix that needs to be homogenized.
4.1.3 Set up the production area according to GMP guidelines.
4.2 Pre-Homogenization Checks
4.2.1 Check and record the initial temperature and viscosity of the cream pre-mix.
4.2.2 Ensure that all safety guards and interlocks of the homogenizer are in place and functioning.
4.2.3 Set the homogenization parameters (pressure, time, temperature) according to the batch record.
4.3 Homogenization Process
4.3.1 Transfer the cream pre-mix into the homogenizer feed hopper.
4.3.2 Start the homogenizer and gradually increase the pressure to the specified level.
4.3.3 Maintain the specified homogenization pressure and time to achieve the desired particle size and cream consistency.
4.3.4
4.4 Post-Homogenization Steps
4.4.1 Upon completion, reduce the pressure gradually and stop the homogenizer.
4.4.2 Transfer the homogenized cream to the designated storage vessel or next processing step.
4.4.3 Perform in-process checks to ensure the cream meets the required specifications (e.g., particle size, viscosity).
4.4.4 Document all process parameters, observations, and results in the batch record.
4.5 Equipment Cleaning and Maintenance
4.5.1 Clean the homogenizer according to the cleaning SOP to prevent cross-contamination.
4.5.2 Perform routine maintenance and calibration of the homogenizer as per the maintenance schedule.
4.5.3 Record all cleaning and maintenance activities in the equipment logbook.
5) Abbreviations, if any
GMP: Good Manufacturing Practices
6) Documents, if any
Batch Manufacturing Record (BMR)
Equipment Logbook
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
FDA Guidance for Industry: Non-Sterile Semisolid Dosage Forms
8) SOP Version
Version 1.0