Operation and Maintenance of Gel Cooling System

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the gel cooling system to ensure proper cooling of gel formulations.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the cooling process.
2. Verify the availability and integrity of gel formulations ready for cooling.
3. Inspect the gel cooling system, including cooling tanks and temperature control units, to ensure they are clean and operational.

4.2 Cooling Process

1. Set up the cooling parameters such as temperature settings and cooling duration according to product specifications.
2. Load the gel containers into the cooling tanks and start the cooling process.
3. Monitor the cooling process to ensure the gel formulations reach the desired temperature for further processing.

4.3 Cleaning and Maintenance

1. Stop the gel cooling system after completing the cooling batch.
2. Clean the cooling tanks and filters to remove any gel residues.
3. Perform routine maintenance tasks such as inspection of cooling coils and calibration of temperature sensors.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Gel formulation specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for gel cooling system

8) SOP Version

Version 1.0