Procedure for Using Heating Jacketed Vessels
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/046 |
| 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 using heating jacketed vessels in ointment manufacturing. Proper use ensures uniform heating, prevents ingredient degradation, and maintains batch consistency.
2. Scope
This SOP applies to all personnel responsible for the operation, monitoring, and maintenance of heating jacketed vessels used in ointment production.
3. Responsibilities
- Production Supervisor: Ensures heating vessel operations adhere to batch requirements.
- Machine Operator: Monitors temperature, pressure, and heating duration.
- Quality Assurance (QA) Personnel: Verifies temperature compliance and process integrity.
- Engineering Technician: Maintains and calibrates heating jacketed vessels.
4. Accountability
The Production and QA Managers are accountable for ensuring that heating jacketed vessels are operated as per GMP standards and documented correctly.
5. Procedure
5.1 Pre-Operational Checks
- Ensure the heating jacketed vessel is clean and free from previous residues.
- Check that temperature sensors and control systems are calibrated.
- Verify the water or oil level in the jacketed heating system.
- Ensure that all valves, fittings, and pressure gauges are intact.
5.2 Setting Up the Heating System
- Fill the jacketed system with the appropriate heating medium (water, oil, or steam).
- Adjust temperature
settings as per batch specifications (e.g., 60°C–80°C).
Start heating gradually to avoid sudden thermal expansion.
Monitor the heating rate to prevent ingredient degradation.
5.3 Loading the Product into the Vessel
- Transfer the pre-weighed raw materials into the vessel.
- Ensure slow-speed stirring to distribute heat evenly.
- Close the lid securely to maintain temperature stability.
5.4 Monitoring the Heating Process
- Check temperature at regular intervals and adjust as needed.
- Ensure no localized overheating occurs.
- Monitor pressure levels in steam-heated systems.
- Check for uniform mixing by observing product consistency.
5.5 Completion of Heating
- Verify that the batch has reached the desired temperature.
- Reduce heating gradually to prevent thermal shock.
- Record final temperature, heating duration, and pressure in the Heating Log.
5.6 Cleaning and Shutdown
- Turn off the heating system and allow the vessel to cool.
- Drain the jacketed system if necessary.
- Flush the vessel with an approved cleaning solution.
- Sanitize all parts 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
- Heating 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: Heating Log
| Date | Batch Number | Heating Temperature (°C) | Pressure (Bar) | Heating Time (Min) | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | 75°C | 2.5 | 30 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | 80°C | 3.0 | 35 | QA Officer |
Annexure-2: Equipment Cleaning Log
| Date | Vessel ID | Cleaning Agent Used | Sanitization Method | Verified By |
|---|---|---|---|---|
| 01/02/2025 | HV-101 | Sodium Hypochlorite | Rinsed and Dried | QA Head |
| 02/02/2025 | HV-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 |