Operation and Maintenance of Gel Mixer Agitator

1) Purpose

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

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the gel mixer 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 gel mixer 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 gel formulations ready for mixing.
3. Inspect the gel mixer agitator, including agitator blades, motor, and controls, to ensure they are clean and in good working condition.

4.2 Mixing Process

1. Set up the gel mixer agitator as per the specifications of the gel batch.
2. Add gel ingredients into the mixer according to the formulation requirements.
3. Start the agitator and adjust speed and mixing time as per the gel formulation.

4.3 Cleaning and Maintenance

1. Stop the mixing process after completing the batch.
2. Empty the mixer and clean all parts thoroughly using approved cleaning agents.
3. Inspect and lubricate moving parts of the agitator regularly to maintain optimal performance.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Gel mixer agitator specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for gel mixer agitator

8) SOP Version

Version 1.0