Procedure for Cooling and Solidification of Ointment Bases
| Department | Production/Quality Assurance (QA)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/033 |
| 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 approach for cooling and solidification of ointment bases. Proper cooling ensures uniform texture, stability, and consistency of the final product.
2. Scope
This SOP applies to all personnel involved in the cooling and solidification process of ointments in the manufacturing unit.
3. Responsibilities
- Production Supervisor: Ensures adherence to cooling parameters and timing.
- Machine Operator: Monitors temperature, stirring speed, and cooling rate.
- Quality Assurance (QA) Personnel: Verifies cooling process compliance with GMP standards.
- Engineering Technician: Ensures cooling system functionality and maintenance.
4. Accountability
The Production and QA Managers are accountable for ensuring that the cooling and solidification process is conducted as per GMP standards and properly documented.
5. Procedure
5.1 Pre-Cooling Preparations
- Ensure that the mixing vessel and cooling system are clean and free from contamination.
- Verify that the temperature sensors and cooling equipment are calibrated and operational.
- Confirm that the emulsification and mixing process has been completed.
5.2 Initiating the Cooling Process
- Gradually lower the temperature to the predefined cooling range (e.g., 40°C–50°C).
- Continue gentle agitation to maintain uniform cooling.
- Ensure no phase separation occurs during cooling.
5.3 Monitoring During Cooling
- Check the temperature at regular intervals.
- Ensure the cooling rate does not exceed the specified limit to prevent crystallization.
- Observe for changes in viscosity and consistency.
5.4 Solidification Stage
- Allow the ointment base to reach its final solidification temperature (e.g., below 35°C).
- Reduce stirring gradually as the mixture solidifies.
- Perform visual and texture inspections to confirm uniformity.
5.5 Completion of Cooling Process
- Check for smooth consistency and absence of air pockets.
- Verify the final temperature before transferring the batch.
- Ensure that the batch meets the viscosity and pH specifications.
5.6 Documentation and Approval
- Record cooling parameters in the Cooling Log.
- QA must verify and approve the cooled batch before further processing.
- Label the batch as “Cooled and Ready for Filling.”
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
7. Documents
- Cooling 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: Cooling Log
| Date | Batch Number | Starting Temp (°C) | Final Temp (°C) | Cooling Time (Min) | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | 70°C | 35°C | 45 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | 75°C | 38°C | 50 | 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 | 70°C | 35°C | QA Head |
| 02/02/2025 | SOP/Ointment/002 | Beeswax | 75°C | 38°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 |