Operation and Maintenance of Cream Mixing Agitator

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the cream mixing agitator to ensure thorough mixing of cream formulations during the manufacturing process.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the cream mixing agitator in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the cream mixing agitator.

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the mixing process.
2. Verify the availability and integrity of cream formulations ready for mixing.
3. Inspect the cream mixing agitator, including agitator blades, shaft, and controls, to ensure they are clean and in good working condition.

4.2 Mixing Process

1. Set up the cream mixing agitator as per the specifications of the cream formulation.
2. Add the required ingredients into the mixing vessel following the approved batch record.
3. Start the mixer agitator and adjust the speed and mixing time as per operational requirements.

4.3 Cleaning and Maintenance

1. Stop the mixing process after completing the batch.
2. Remove the mixing vessel from the agitator and clean it thoroughly using approved cleaning agents.
3. Inspect and clean the agitator blades, shaft, and seals to ensure they are free from any residue.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Cream mixing agitator specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for cream mixing agitator

8) SOP Version

Version 1.0