Standard Operating Procedure for Cleaning of Inline Filters and Screens in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/163/2025 |
| Supersedes | SOP/ELX/163/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the standard procedure for disassembly, cleaning, inspection, and reassembly of inline filters and mesh screens used in elixir manufacturing processes to ensure product quality and compliance with cGMP standards.
2. Scope
This SOP applies to all inline filters, strainers, and mesh screens connected to pipelines, filling lines, holding tanks, and transfer units in the Elixir Department.
3. Responsibilities
- Production Operator:
- Disassemble, clean, and inspect inline filters/screens post-batch.
- Document the activity in the cleaning logbook.
- Engineering Department:
- Support complex filter housing disassembly and maintenance of seals and clamps.
- QA Officer:
- Verify cleaning effectiveness and authorize reuse or storage of filters/screens.
4. Accountability
The Production Head is accountable for timely cleaning post each batch. The Engineering Head ensures system operability and integrity. QA Head ensures compliance and approval before reuse.
5. Procedure
5.1 Disassembly
- Ensure product transfer is complete and line is emptied.
- Switch off equipment and label as “Under Maintenance.”
- Wear PPE including gloves, face mask, apron, and safety goggles.
- Loosen clamp bolts or screw fittings to open the filter housing.
- Remove mesh screen or cartridge filter carefully without bending or damaging.
5.2 Cleaning
- Rinse filters/screens under running purified water to remove loose particles.
- Immerse in 1% non-ionic detergent solution and brush gently with a nylon brush.
- Pay special attention to mesh corners, crevices, and filter surface.
- Rinse thoroughly with purified water until no foam or residue remains.
- If applicable, perform final rinse using hot purified water (60–80°C).
5.3 Drying and Inspection
- Dry the filter/screen using compressed air filtered through 0.22 µm filter or place in drying cabinet.
- Inspect visually for:
- Clogging
- Tears or mesh distortion
- Corrosion or rust marks
- If any damage is observed, report to Engineering and replace the filter.
5.4 Reassembly
- Reassemble the filter into the housing using proper orientation.
- Ensure gaskets or O-rings are intact and properly seated.
- Tighten clamps or screws using torque wrench if specified.
5.5 Documentation and Release
- Record the cleaning activity in the Inline Filter Cleaning Logbook (Annexure-1).
- QA to verify filter condition and cleanliness.
- Label as “CLEANED” and approve for next use.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- CIP: Clean-In-Place
7. Documents
- Inline Filter Cleaning Logbook (Annexure-1)
- Filter Inspection Checklist
- Swab/Rinse Test Reports (if applicable)
8. References
- 21 CFR Part 211.67 – Cleaning of Equipment
- WHO TRS 986 Annex 2 – Good Manufacturing Practices
- ICH Q9 – Quality Risk Management
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Inline Filter Cleaning Logbook
| Date | Filter ID | Equipment Name | Cleaned By | QA Verified | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | FILT-ELX-03 | Filling Line 2 | Rajesh Kumar | Sunita Reddy | No damage, Cleaned |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New Procedure Documentation | QA Head |
| 11/04/2025 | 2.0 | Added hot water rinse and filter damage inspection | Enhanced Compliance | QA Head |