Procedure for Using a Homogenizer in Ointment Production
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/042 |
| 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 proper method for operating a homogenizer during ointment production. Homogenization ensures uniform particle distribution, enhances stability, and improves the texture of the final product.
2. Scope
This SOP applies to all personnel involved in the operation, maintenance, and monitoring of homogenizers used in ointment manufacturing.
3. Responsibilities
- Production Supervisor: Ensures homogenization is carried out as per batch requirements.
- Machine Operator: Operates and monitors the homogenizer.
- Quality Assurance (QA) Personnel: Conducts in-process checks to confirm uniformity.
- Engineering Technician: Maintains and calibrates the homogenizer.
4. Accountability
The Production and QA Managers are accountable for ensuring that the homogenization process follows GMP standards and is properly documented.
5. Procedure
5.1 Pre-Operational Checks
- Ensure the homogenizer is clean and sanitized.
- Verify the calibration status of pressure and speed settings.
- Inspect seals, valves, and moving parts for wear or damage.
- Check that all connections are secure and there are no leaks.
5.2 Loading the Ointment for Homogenization
- Transfer the pre-mixed ointment into the homogenization chamber.
- Ensure the temperature is within the required range (e.g., 40°C–50°C).
- Close the
homogenizer lid securely before starting the operation.
5.3 Homogenization Process
- Set the homogenizer speed and pressure according to batch specifications.
- Start the homogenizer and allow the ointment to circulate through the system.
- Maintain homogenization for the defined duration (e.g., 20–30 minutes).
- Monitor the pressure gauge to ensure it stays within the prescribed limits.
5.4 Monitoring During Homogenization
- Observe the consistency and flow of the ointment.
- Check for uniform particle size and dispersion.
- Ensure that no air bubbles are introduced into the mixture.
5.5 Completion of Homogenization
- Stop the homogenizer and allow the batch to settle.
- Verify that the product meets viscosity and uniformity specifications.
- Record final parameters (pressure, time, speed) in the Homogenization Log.
5.6 Cleaning and Shutdown
- Drain any remaining ointment from the system.
- Flush the homogenizer with an approved cleaning solution.
- Sanitize all parts and reassemble for the next batch.
- Record cleaning details in the Equipment Cleaning Log.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- RPM – Revolutions Per Minute
- BMR – Batch Manufacturing Record
7. Documents
- Homogenization 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: Homogenization Log
| Date | Batch Number | Pressure (Bar) | Speed (RPM) | Time (Min) | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | 100 | 5000 | 20 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | 120 | 4800 | 25 | QA Officer |
Annexure-2: Equipment Cleaning Log
| Date | Homogenizer ID | Cleaning Agent Used | Sanitization Method | Verified By |
|---|---|---|---|---|
| 01/02/2025 | HM-101 | Sodium Hypochlorite | Rinsed and Dried | QA Head |
| 02/02/2025 | HM-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 |