Procedure for Maintaining Scraper Blade Mixers
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/044 |
| 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 establish a systematic approach for maintaining scraper blade mixers used in ointment production. Proper maintenance ensures efficient mixing, prevents contamination, and extends equipment lifespan.
2. Scope
This SOP applies to all personnel responsible for the operation, cleaning, and maintenance of scraper blade mixers in the manufacturing facility.
3. Responsibilities
- Production Supervisor: Ensures scraper blade mixers are maintained as per schedule.
- Machine Operator: Performs routine checks and identifies maintenance needs.
- Quality Assurance (QA) Personnel: Verifies cleanliness and operational efficiency.
- Engineering Technician: Conducts preventive and corrective maintenance.
4. Accountability
The Production and QA Managers are accountable for ensuring that scraper blade mixer maintenance follows GMP standards and is properly documented.
5. Procedure
5.1 Pre-Use Inspection
- Check that the scraper blade mixer is clean and free of residue.
- Ensure that the blade is securely attached and shows no signs of wear.
- Verify that the mixing vessel is properly aligned with the scraper blade.
5.2 Routine Maintenance
- Lubricate moving parts to prevent friction-related wear.
- Inspect and tighten fasteners to secure the blade.
- Ensure the scraper blade does not have cracks or
sharp edges that may contaminate the batch.
Monitor motor function and check for unusual noises during operation.
5.3 Cleaning After Each Batch
- Disassemble scraper blade components following manufacturer guidelines.
- Wash the blade, mixing vessel, and surrounding areas with an approved cleaning agent.
- Rinse thoroughly with purified water to remove any residues.
- Sanitize all parts and reassemble before the next use.
5.4 Preventive Maintenance Schedule
- Perform deep cleaning and sanitization weekly.
- Conduct blade wear analysis monthly.
- Replace worn-out scraper blades as per the manufacturer’s recommendation.
- Calibrate the scraper blade mixer every six months.
5.5 Handling Equipment Failures
- Stop production immediately if any mechanical issue is detected.
- Document the fault and notify the Engineering department.
- Ensure necessary repairs or replacements are conducted before resuming operation.
5.6 Documentation and Approval
- Record all maintenance activities in the Equipment Maintenance Log.
- QA must review and approve maintenance records.
- Retain maintenance records for audits and inspections.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
- RPM – Revolutions Per Minute
7. Documents
- Equipment Maintenance Log (Annexure-1)
- Cleaning and Sanitization 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: Equipment Maintenance Log
| Date | Machine ID | Maintenance Type | Action Taken | Verified By |
|---|---|---|---|---|
| 01/02/2025 | SM-101 | Routine Inspection | Lubricated bearings | QA Officer |
| 02/02/2025 | SM-102 | Blade Replacement | Installed new scraper | QA Officer |
Annexure-2: Cleaning and Sanitization Log
| Date | Machine ID | Cleaning Agent Used | Sanitization Method | Verified By |
|---|---|---|---|---|
| 01/02/2025 | SM-101 | Sodium Hypochlorite | Rinsed and Dried | QA Head |
| 02/02/2025 | SM-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 |