Operation and Maintenance of Suppository Cooling Tunnel

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the suppository cooling tunnel to ensure proper cooling and solidification of suppositories.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the cooling process.
2. Verify the availability and integrity of suppositories ready for cooling.
3. Inspect the cooling tunnel, including conveyor belts and cooling fans, to ensure they are clean and operational.

4.2 Cooling Process

1. Set up the cooling parameters such as conveyor speed and temperature according to suppository formulation requirements.
2. Load the suppositories onto the conveyor belt of the cooling tunnel and start the cooling process.
3. Monitor the cooling process to ensure suppositories reach the desired solidification state.

4.3 Cleaning and Maintenance

1. Stop the cooling tunnel after completing the cooling batch.
2. Clean the conveyor belts and cooling fans thoroughly to remove any residue.
3. Perform routine maintenance tasks such as lubrication of conveyor components and inspection of cooling system.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Suppository formulation record

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for suppository cooling tunnel

8) SOP Version

Version 1.0