Operation and Maintenance of Gel Manufacturing Vessel

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the gel manufacturing vessel to ensure efficient production of gel formulations.

2) Scope

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

4) Procedure

4.1 Preparation

1. Verify the availability of raw materials and batch records for gel production.
2. Inspect the manufacturing vessel for cleanliness and proper functioning of agitators, temperature controls, and other components.
3. Ensure all safety procedures are followed, including checking emergency stop mechanisms.

4.2 Gel Manufacturing Process

1. Set the temperature and agitation speed according to batch specifications.
2. Add raw materials into the vessel and initiate mixing.
3. Monitor the gel manufacturing process, adjusting parameters as necessary to maintain quality.

4.3 Cleaning and Maintenance

1. After completing the manufacturing process, drain the vessel and clean it thoroughly using approved cleaning agents.
2. Inspect and sanitize all parts of the vessel, including seals and filters.
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 manufacturing vessel specifications

7) Reference, if any

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

8) SOP Version

Version 1.0