Standard Operating Procedure for Disassembling Equipment for Manual Cleaning in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/180/2025 |
| Supersedes | SOP/ELX/180/2022 |
| 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 step-by-step procedure for safe and compliant disassembly of equipment components prior to manual cleaning in the Elixir Manufacturing Department.
2. Scope
This SOP applies to all dismantlable components of elixir manufacturing equipment including mixing vessels, transfer pipes, valves, gaskets, agitators, nozzles, and accessories requiring manual cleaning.
3. Responsibilities
- Production Operator:
- Disassemble the equipment safely and perform manual cleaning.
- Ensure all parts are labeled and tracked during disassembly.
- Engineering Department:
- Assist in disassembly of complex parts if required.
- QA Department:
- Verify disassembly and cleaning as per checklist and approve reassembly.
4. Accountability
The Production Head is accountable for ensuring compliance. QA Head is responsible for verification of disassembly and cleanliness. Engineering Head supports technical integrity and safety of disassembly process.
5. Procedure
5.1 Preparation
- Switch off power and isolate utility
connections (electricity, steam, compressed air) before disassembly.
Drain all product and rinse materials from equipment.
Gather appropriate tools: spanners, screwdrivers, gloves, lint-free cloth, etc.
5.2 Disassembly Procedure
- Remove detachable parts in the following order unless equipment-specific instructions suggest otherwise:
- Gaskets and clamps
- Transfer nozzles and inlet/outlet valves
- Spray balls, agitators, shafts
- Sight glasses, manway covers
- Tag and place each part on a clean tray labeled with equipment ID.
- Inspect for wear and tear, damage, or contamination. Report non-compliant parts to Engineering.
5.3 Manual Cleaning
- Clean each disassembled part using:
- Soft brush and 1% approved cleaning detergent solution
- Followed by purified water rinse until free from detergent (check for absence of foam)
- Sanitize using 70% IPA or as specified in the cleaning validation protocol.
- Dry using lint-free cloth or allow to air dry on clean surface.
5.4 Reassembly
- Ensure all parts are completely dry before reassembly.
- Follow reverse order of disassembly. Do not force-fit any component.
- Apply lubrication (if required) using only approved food/pharma-grade lubricants.
- Check tightness of clamps and seals.
5.5 Post-Cleaning Verification
- QA to perform visual inspection for cleanliness and completeness.
- Record disassembly, cleaning, and reassembly activity in Equipment Disassembly Logbook (Annexure-1).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- IPA: Isopropyl Alcohol
7. Documents
- Equipment Disassembly Logbook (Annexure-1)
- Cleaning Verification Checklist
8. References
- ICH Q7 – GMP Guidelines for Active Pharmaceutical Ingredients
- 21 CFR Part 211.67 – Cleaning and Maintenance
- WHO TRS 986 Annex 4 – Equipment Cleaning
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 Disassembly Logbook
| Date | Equipment ID | Parts Disassembled | Cleaned By | Reassembled By | QA Verified | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | MXR-ELX-12 | Nozzle, Gasket, Valve | Rajesh Kumar | Sunita Reddy | Neha Patil | Visually Cleaned and Approved |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Included tagging, drying, and reassembly lubrication | GMP Improvement | QA Head |