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.

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. Verify the availability of gel formulation ingredients and batch records.
2. Inspect the gel mixer agitator for cleanliness and proper functioning of agitator blades, speed controls, and safety guards.
3. Ensure all safety protocols are followed, including wearing appropriate PPE.

4.2 Mixing Process

1. Set the required mixing speed and timer according to batch specifications.
2. Add gel ingredients into the mixer and start the agitator.
3. Monitor the mixing process to achieve uniform blending of gel components.

4.3 Cleaning and Maintenance

1. After completing the mixing process, drain the mixer and clean it thoroughly using approved cleaning agents.
2. Inspect and lubricate agitator components as per maintenance schedule.
3. Document cleaning and maintenance activities in the logbook.

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