Operation and Maintenance of Gel Storage Unit

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the gel storage unit to ensure proper storage conditions for gel formulations.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the gel storage area is clean, well-organized, and maintained at the appropriate temperature and humidity levels.
2. Verify the availability and integrity of gel containers or vessels ready for storage.
3. Inspect the gel storage unit, including temperature controls and monitoring systems, to ensure they are functioning correctly.

4.2 Storage Process

1. Transfer gel formulations into designated storage containers or vessels.
2. Label each container with batch details, expiry dates, and any other relevant information.
3. Place the containers or vessels in their designated storage locations according to gel stability requirements.

4.3 Monitoring and Maintenance

1. Regularly monitor the temperature and humidity levels inside the gel storage unit using calibrated monitoring devices.
2. Inspect containers or vessels periodically for signs of leakage, damage, or contamination.
3. Perform routine maintenance tasks such as cleaning storage shelves, checking seals, and replacing monitoring sensors as needed.

5) Abbreviations, if any

N/A

6) Documents, if any

Storage log, Inventory records, Gel storage unit specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for gel storage unit

8) SOP Version

Version 1.0