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 |