Operation and Maintenance of Gel Mixing Vessel

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the gel mixing vessel to ensure consistent mixing of gel formulations.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the gel mixing vessel 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 mixing vessel.

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 ingredients ready for mixing.
3. Inspect the gel mixing vessel, including agitators and temperature controls, to ensure they are clean and functioning properly.

4.2 Mixing Process

1. Set up the mixing parameters such as speed, temperature, and mixing time according to gel formulation specifications.
2. Load the gel ingredients into the mixing vessel according to the batch recipe.
3. Start the mixing process and monitor to achieve homogeneous mixing of gel.

4.3 Cleaning and Maintenance

1. Stop the mixing vessel after completing the mixing batch.
2. Empty the vessel and clean all surfaces, including agitators and internal walls, to remove any residues.
3. Perform preventive maintenance tasks such as checking seals, lubricating bearings, and inspecting electrical components.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Gel mixing specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for gel mixing vessel

8) SOP Version

Version 1.0