Operation and Maintenance of Gel Deaeration Unit

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the gel deaeration unit to ensure proper removal of air bubbles from gel formulations.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the deaeration process.
2. Verify the availability and integrity of gel formulations ready for deaeration.
3. Inspect the gel deaeration unit, including vacuum pump and deaeration chamber, to ensure they are clean and in good working condition.

4.2 Deaeration Process

1. Set up the deaeration parameters such as vacuum level and duration according to gel formulation specifications.
2. Transfer the gel formulation into the deaeration chamber and start the vacuum pump to initiate the deaeration process.
3. Monitor the deaeration process to ensure complete removal of air bubbles from the gel formulation.

4.3 Cleaning and Maintenance

1. Stop the vacuum pump after completing the deaeration cycle.
2. Release the vacuum and open the deaeration chamber carefully.
3. Clean the deaeration chamber and associated components thoroughly to remove any residue or contaminants.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Gel deaeration unit specifications

7) Reference, if any

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

8) SOP Version

Version 1.0