Procedure for Heating and Melting Base Materials
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/023 |
| 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 the standardized method for heating and melting base materials used in ointment manufacturing. Proper heating ensures uniform melting, prevents degradation, and maintains product consistency.
2. Scope
This SOP applies to all personnel responsible for handling, heating, and melting base materials such as waxes, emulsifiers, and oils used in ointment production.
3. Responsibilities
- Production Supervisor: Ensures adherence to heating and melting protocols.
- Machine Operator: Operates the heating and melting equipment.
- Quality Assurance (QA) Personnel: Verifies the temperature control and melting process.
- Engineering Technician: Maintains and troubleshoots heating systems.
4. Accountability
The Production and QA Managers are accountable for ensuring that all heating and melting operations are conducted as per GMP standards and documented correctly.
5. Procedure
5.1 Pre-Heating Checks
- Ensure that the heating vessel is clean and dry.
- Verify that temperature probes and gauges are calibrated.
- Check the availability of base materials and their batch numbers.
- Ensure proper ventilation in the melting area.
5.2 Loading of Base Materials
- Weigh the required quantity of base materials as per the batch manufacturing record (BMR).
- Transfer solid materials
(e.g., waxes, emulsifiers) into the heating vessel.
Slowly add liquid oils and other excipients.
5.3 Heating and Melting Process
- Set the temperature of the heating vessel according to formulation specifications.
- Maintain a controlled heating rate to avoid overheating.
- Stir continuously to ensure uniform melting and prevent scorching.
- Monitor and record the temperature at regular intervals.
5.4 Homogenization (If Required)
- If the formulation requires homogenization, gradually increase mixing speed.
- Ensure all components are fully melted and uniformly blended.
- Perform visual and temperature checks to confirm complete melting.
5.5 Cooling and Holding
- Once fully melted, maintain the mixture at the specified holding temperature.
- Check for any separation or undissolved particles.
- Record final temperature and time before proceeding to further processing.
5.6 Documentation and Approval
- Record all heating and melting parameters in the Heating Log.
- QA must verify and approve the melted mixture before further processing.
- Label the melted base material container as “Ready for Use.”
6. Abbreviations
- BMR – Batch Manufacturing Record
- QA – Quality Assurance
- GMP – Good Manufacturing Practices
- cP – Centipoise (Viscosity Measurement)
7. Documents
- Heating Log (Annexure-1)
- Temperature Monitoring Report (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 | Material Name | Heating Temperature (°C) | Time (Min) | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | White Petrolatum | 70°C | 30 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | Beeswax | 75°C | 40 | QA Officer |
Annexure-2: Temperature Monitoring Report
| Date | Batch Number | Material Name | Initial Temp (°C) | Final Temp (°C) | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | White Petrolatum | 20°C | 70°C | QA Head |
| 02/02/2025 | SOP/Ointment/002 | Beeswax | 22°C | 75°C | 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 |