Operation and Maintenance of Cream Cooling Jacket

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the cream cooling jacket to ensure proper cooling of cream formulations during the manufacturing process.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the cream cooling jacket is clean and sanitized before use.
2. Verify the availability of cream formulations ready for cooling.
3. Inspect the cream cooling jacket, including cooling coils and temperature controls, to ensure they are clean and in good working condition.

4.2 Cooling Process

1. Set the temperature of the cooling jacket to the specified level required for the cream batch.
2. Transfer the cream into the jacketed vessel and start the cooling process.
3. Monitor the temperature closely and adjust settings if necessary to achieve the desired cooling rate.

4.3 Cleaning and Maintenance

1. After completing the cooling process, remove the cream and clean the cooling jacket thoroughly using approved cleaning agents.
2. Inspect and clean the cooling coils regularly to prevent buildup of residues.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Cream cooling jacket specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for cream cooling jacket

8) SOP Version

Version 1.0