Standard Operating Procedure for Cleaning of Milling Equipment in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/074/2025 |
| Supersedes | SOP/API/074/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a standard cleaning procedure for milling equipment such as jet mills, pin mills, hammer mills, and impact mills used in API manufacturing, to prevent product cross-contamination and maintain GMP compliance.
2. Scope
This SOP applies to all milling equipment and their associated parts used in the production of APIs in the API manufacturing facility. It includes routine, changeover, and campaign-based cleaning.
3. Responsibilities
- Production Operator: Perform equipment cleaning as per this SOP and document activities.
- Production Supervisor: Verify equipment cleanliness and ensure proper labeling and status update.
- QA Department: Review and approve cleaning verification and clearance documentation.
- Engineering Department: Assist in disassembly/assembly and maintain maintenance records.
4. Accountability
The Production Head is accountable for ensuring cleaning compliance. QA Head is responsible for approving line clearance and ensuring documentation readiness.
5. Procedure
5.1 Cleaning Types
- Product-to-Same Product: Campaign cleaning (if justified by cleaning validation)
- Product-to-Different Product: Full cleaning with verification
- After Maintenance: Full cleaning and requalification of equipment
5.2 Pre-Cleaning Requirements
- Wear appropriate PPE including gloves, mask, and apron.
- Ensure power supply to the equipment is turned off and display “Under Cleaning” tag.
- Record start time in the “Milling Equipment Cleaning Log” (Annexure-1).
5.3 Disassembly and Manual Cleaning
- Disassemble the hopper, milling chamber, screens, blades, and discharge units.
- Use compressed air to remove adhered powders and particles.
- Wipe with dry lint-free cloth followed by wet mopping using potable water.
- Use 0.5–1% cleaning agent solution if visible residues persist. Rinse thoroughly with purified water.
5.4 Final Rinse and Drying
- Perform final rinse with purified water until rinsate is clear.
- Wipe parts dry with lint-free cloth and allow to air dry completely in clean area.
- Visually inspect all parts for cleanliness and dryness.
5.5 Reassembly and Status Labeling
- Reassemble cleaned parts and ensure all clamps, bolts, and gaskets are tightened securely.
- Affix “Cleaned” label with:
- Equipment Name
- Cleaned By
- Date
- Next Use Product
- Update equipment cleaning record in the BMR.
5.6 Cleaning Verification
- Perform visual inspection and swab testing as per cleaning validation protocol.
- Swab sample should comply with acceptance limits established in cleaning validation (e.g., NMT 10 ppm or 1 µg/cm²).
- Do not release equipment until QA has reviewed and approved results.
6. Abbreviations
- SOP: Standard Operating Procedure
- PPE: Personal Protective Equipment
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- NMT: Not More Than
7. Documents
- Milling Equipment Cleaning Log (Annexure-1)
- Swab Test Report
- Cleaning Validation Protocol
8. References
- ICH Q7 – GMP Guide for APIs
- FDA Cleaning Validation Guidelines
- Internal Equipment Cleaning SOPs and Validation Reports
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Milling Equipment Cleaning Log
| Date | Equipment ID | Product | Type of Cleaning | Cleaning Agent | Performed By | Checked By |
|---|---|---|---|---|---|---|
| 13/04/2025 | JM-001 | API-XYZ | Full | 1% NaOH |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | Equipment Validation | QA Head |
| 13/04/2025 | 2.0 | Swab Testing and Disassembly Steps Updated | Audit Compliance | QA Head |