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 during the manufacturing process.

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 unit is clean and sanitized before use.
2. Verify the availability of gel formulations ready for storage.
3. Inspect the gel storage unit, including shelves and temperature controls, to ensure they are clean and in good working condition.

4.2 Storage Process

1. Set the temperature of the storage unit to the specified level required for the gel formulations.
2. Transfer the gel containers into the designated storage areas based on their stability requirements.
3. Monitor the temperature and humidity levels regularly to ensure they are within specified limits.

4.3 Cleaning and Maintenance

1. Regularly clean the interior of the gel storage unit using approved cleaning agents to prevent contamination.
2. Check and calibrate temperature controls periodically to maintain accurate storage conditions.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Gel storage unit specifications

7) Reference, if any

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

8) SOP Version

Version 1.0