Standard Operating Procedure for Emulsification in Lotion Manufacturing

1) Purpose

The purpose of this SOP is to outline the standardized procedure for the emulsification process in the production of lotions to ensure consistency, quality, and compliance with regulatory standards.

2) Scope

This SOP applies to all personnel involved in the manufacturing of lotions, specifically those responsible for the emulsification process within the production facility.

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Production Operators:

• Execute the emulsification process as per the SOP.
• Ensure all equipment is properly cleaned and maintained.

Quality Control Personnel:

• Verify the emulsification process parameters and ensure compliance with quality standards.

Production Supervisors:

• Oversee the process to ensure adherence to SOP and troubleshoot any issues.

4) Procedure

4.1 Pre-Operational Checks:

• Ensure all equipment is clean and in good working condition.
• Verify the availability and quality of raw materials.

4.2 Emulsification Process:

1. Preparation:
   1. Measure and prepare the required quantities of oil phase and water phase components.
   2. Heat the oil phase and water phase separately to the specified temperature (e.g., 70-75°C).
2. Mixing:
   1. Slowly add the oil phase to the water phase under continuous stirring using an emulsifier.
   2. Maintain the stirring speed and temperature as per the formulation requirements.
3. Cooling:
   1. After complete addition of the oil phase, continue stirring and begin cooling the emulsion gradually.
   2. Monitor the cooling rate and ensure uniform cooling to room temperature.
4. Post-Processing:
   1. Transfer the emulsified lotion to the designated storage containers.
   2. Label the containers with the batch number and date of production.

5) Abbreviations, if any

None.

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Equipment Logbook

7) Reference, if any

• Good Manufacturing Practice (GMP) guidelines
• Regulatory requirements as per FDA/EMA standards

8) SOP Version

Version 1.0