Procedure for Cleaning Homogenizers
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/052 |
| 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 method for cleaning homogenizers post-manufacturing to prevent cross-contamination, maintain product quality, and comply with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel responsible for cleaning and sanitizing homogenizers used in the ointment manufacturing process.
3. Responsibilities
- Production Supervisor: Ensures that homogenizer cleaning is performed as per the SOP.
- Machine Operator: Conducts preliminary rinsing and prepares the homogenizer for cleaning.
- Cleaning Personnel: Executes the detailed cleaning procedure.
- Quality Assurance (QA) Personnel: Inspects and approves the cleanliness of the homogenizer.
4. Accountability
The Production and QA Managers are accountable for ensuring that homogenizer cleaning procedures are properly followed and documented.
5. Procedure
5.1 Pre-Cleaning Preparations
- Ensure the homogenizer is switched off and safely disconnected from the power supply.
- Wear appropriate Personal Protective Equipment (PPE), including gloves, goggles, and aprons.
- Remove any remaining product from the homogenizer.
- Identify and remove any detachable parts for separate cleaning.
5.2 Initial Rinsing
- Flush the homogenizer chamber and blades with warm purified water.
- Drain the water completely before proceeding to detergent cleaning.
5.3 Cleaning Process
5.3.1 Detergent Cleaning
- Prepare a cleaning solution using an
approved detergent.
Circulate the solution through the homogenizer system for 15 minutes.
Scrub internal and external surfaces with soft brushes.
Ensure the removal of any ointment residues from the homogenization chamber.
5.3.2 High-Pressure Rinsing
- Use high-pressure purified water to thoroughly rinse detergent residues.
- Repeat the rinsing process until all traces of detergent are removed.
5.3.3 Final Sanitization
- Apply an approved sanitizing agent (e.g., 70% ethanol or peracetic acid solution).
- Allow sufficient contact time (10-15 minutes) for effective disinfection.
- Perform a final rinse with purified water to remove sanitizing residues.
5.4 Post-Cleaning Inspection
- Conduct a visual inspection to ensure no residues remain.
- Perform swab testing to verify microbial cleanliness.
- Record the results in the Cleaning Log.
5.5 Documentation and Approval
- Log all cleaning activities in the Cleaning Record.
- QA personnel must review and approve the cleaning before the next batch.
- Store records for compliance audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- PPE – Personal Protective Equipment
7. Documents
- Cleaning Log (Annexure-1)
- Cleaning Validation Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleaning Log
| Date | Homogenizer ID | Cleaning Solution Used | Sanitization Agent | Verified By |
|---|---|---|---|---|
| 01/02/2025 | HM-101 | Detergent Solution | 70% Ethanol | QA Officer |
| 02/02/2025 | HM-102 | Alkaline Cleaner | Peracetic Acid | QA Officer |
Annexure-2: Cleaning Validation Report
| Date | Homogenizer ID | Swab Test Result | Microbial Limits | Final Status | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | HM-101 | Pass | Within Limit | Approved | QA Head |
| 02/02/2025 | HM-102 | Pass | Within Limit | Approved | 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 |