Operation and Maintenance of Gel Mixer

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the gel mixer to ensure uniform 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 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.

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, including mixing blades, vessel, and controls, to ensure they are clean and in good working condition.

4.2 Mixing Process

1. Set up the gel mixer as per the specifications of the gel formulation.
2. Add the required ingredients into the mixing vessel following the approved batch record.
3. Start the mixer 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. Empty the mixing vessel and clean it thoroughly using approved cleaning agents.
3. Inspect and clean the mixing blades, vessel interior, 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, Gel mixer specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for gel mixer

8) SOP Version

Version 1.0