Procedure for Operating Cooling Tunnels

Department	Production/Engineering/Quality Assurance (QA)
SOP No.	SOP/Ointment/045
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a standardized process for operating cooling tunnels in ointment manufacturing. Proper cooling ensures uniform solidification, maintains product integrity, and prevents batch contamination.

2. Scope

This SOP applies to all personnel responsible for the handling, operation, and maintenance of cooling tunnels in the ointment production process.

3. Responsibilities

• Production Supervisor: Ensures cooling tunnel operations adhere to process specifications.
• Machine Operator: Controls temperature, conveyor speed, and airflow in the cooling tunnel.
• Quality Assurance (QA) Personnel: Monitors product cooling and records deviations.
• Engineering Technician: Conducts preventive and corrective maintenance on cooling tunnels.

4. Accountability

The Production and QA Managers are accountable for ensuring that cooling tunnel operations comply with GMP standards and are properly documented.

5. Procedure

5.1 Pre-Operational Checks

• Ensure the cooling tunnel is clean and free of previous batch residues.
• Verify temperature settings and airflow functionality.
• Check the conveyor belt for proper alignment and smooth operation.
• Ensure that the cooling chamber is free from dust, condensation, or obstruction.

5.2 Setting the Cooling Parameters

• Adjust the cooling temperature as per batch specifications (e.g., 20°C–25°C).
• Set the conveyor speed to allow uniform cooling.
• Ensure adequate airflow circulation within the tunnel.

5.3 Loading the Product into the Cooling Tunnel

• Carefully place the filled containers onto the conveyor belt.
• Ensure even spacing to allow consistent cooling.
• Start the conveyor belt at the required speed.

5.4 Monitoring the Cooling Process

• Check the temperature at regular intervals.
• Ensure no condensation forms on the containers.
• Monitor for uniform solidification of ointments.

5.5 Completion of Cooling

• Ensure the product reaches the desired temperature before exiting the tunnel.
• Confirm consistency and texture through a sample check.
• Record cooling parameters in the Cooling Tunnel Log.

5.6 Cleaning and Shutdown

• Turn off the cooling system after batch completion.
• Remove any residual product from the conveyor belt.
• Sanitize all cooling tunnel components and record cleaning details in the Equipment Cleaning Log.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record

7. Documents

• Cooling Tunnel Log (Annexure-1)
• Equipment Cleaning Log (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices
• Equipment Manufacturer Guidelines

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cooling Tunnel Log

Date	Batch Number	Cooling Temperature (°C)	Conveyor Speed	Cooling Time (Min)	Verified By
01/02/2025	SOP/Ointment/001	22°C	1.5 m/min	30	QA Officer
02/02/2025	SOP/Ointment/002	24°C	1.2 m/min	35	QA Officer

Annexure-2: Equipment Cleaning Log

Date	Cooling Tunnel ID	Cleaning Agent Used	Sanitization Method	Verified By
01/02/2025	CT-101	Sodium Hypochlorite	Rinsed and Dried	QA Head
02/02/2025	CT-102	Ethyl Alcohol	Wiped and Flushed	QA Head

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head