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 in 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. Verify the availability of gel batches and batch records.
2. Inspect the gel storage unit for cleanliness and ensure proper functioning of temperature controls, humidity settings, and safety alarms.
3. Ensure all safety protocols are followed, including checking emergency shutdown procedures.

4.2 Storage Process

1. Set the required temperature and humidity levels in the storage unit as per gel specifications.
2. Store gel batches in designated areas of the unit, ensuring proper labeling and segregation.
3. Monitor temperature and humidity regularly to maintain optimal storage conditions.

4.3 Cleaning and Maintenance

1. Regularly clean the interior of the storage unit to prevent contamination and maintain hygiene.
2. Inspect and replace temperature and humidity sensors as per maintenance schedule.
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 storage unit specifications

7) Reference, if any

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

8) SOP Version

Version 1.0