Procedure for Initial Heating Stage in Ointment Manufacturing
| Department | Production/Quality Assurance (QA)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/031 |
| 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 systematic approach for the initial heating stage in ointment manufacturing. Proper heating ensures uniform melting of base materials, enhances ingredient solubility, and maintains product consistency.
2. Scope
This SOP applies to all personnel responsible for the heating of waxes, oils, emulsifiers, and other base materials in the ointment manufacturing process.
3. Responsibilities
- Production Supervisor: Ensures adherence to heating parameters and safety protocols.
- Machine Operator: Monitors temperature, heating duration, and mixing conditions.
- QA Personnel: Verifies temperature accuracy and compliance with GMP requirements.
- Engineering Technician: Ensures heating system functionality and calibration.
4. Accountability
The Production and QA Managers are accountable for ensuring that the initial heating stage is performed as per GMP and documented correctly.
5. Procedure
5.1 Pre-Heating Preparations
- Ensure the heating vessel is clean and dry.
- Check the availability of required base materials as per the Batch Manufacturing Record (BMR).
- Verify the calibration status of temperature sensors.
5.2 Loading of Base Materials
- Weigh and transfer waxes, oils, and emulsifiers into the heating vessel.
- Use a slow agitation setting to ensure
uniform heat distribution.
Ensure no contamination occurs during material transfer.
5.3 Heating Process
- Gradually increase the temperature to the specified range (e.g., 60°C–80°C).
- Monitor heating rate to prevent thermal degradation.
- Ensure constant stirring to maintain homogeneity.
5.4 Monitoring During Heating
- Check temperature at regular intervals using a calibrated thermometer.
- Observe for uniform melting without residue formation.
- Ensure no overheating or burning occurs.
5.5 Completion of Heating Stage
- Confirm complete melting of all ingredients.
- Hold the mixture at the final heating temperature for the required duration.
- Record final temperature and time before proceeding to emulsification.
5.6 Documentation and Approval
- Record heating parameters in the Heating Log.
- QA must verify and approve the batch before further processing.
- Label the batch as “Melted and Ready for Mixing.”
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
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 |