Standard Operating Procedure for Cleaning Agitator Shafts and Seals in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/188/2025 |
| Supersedes | SOP/ELX/188/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To describe the procedure for thorough cleaning of agitator shafts and mechanical seals used in elixir manufacturing to ensure removal of residues and prevent cross-contamination or mechanical damage.
2. Scope
This SOP applies to all types of agitator shafts (top-mounted, bottom-mounted, side-entry) and their mechanical or lip seals in mixing tanks used in the Elixir Department.
3. Responsibilities
- Production Operator:
- Disassemble (if required), clean, and reassemble agitator shafts and seals.
- Engineering Personnel:
- Assist with seal removal or shaft dismounting where required.
- QA Officer:
- Inspect post-cleaning surfaces and ensure cleanliness verification.
4. Accountability
The Production Head is accountable for execution of this SOP. QA ensures compliance and Engineering ensures safe mechanical disassembly and assembly.
5. Procedure
5.1 Preparation
- Ensure the tank is emptied and disconnected from power and utilities.
- Wear PPE: gloves, apron,
goggles, and antistatic shoes.
Prepare cleaning tools: lint-free cloths, soft nylon brushes, approved detergent (1–2%), and purified water.
5.2 Shaft Cleaning (Without Dismantling)
- Clean visible parts of shaft using detergent-soaked cloth and brush.
- Rotate shaft manually or with jog mode (if permitted) to clean full surface.
- Pay special attention to joint lines, welds, and hard-to-reach curves.
- Rinse thoroughly with purified water until free from foam or residue.
5.3 Seal Cleaning (With or Without Removal)
- If removal is necessary, get approval and support from Engineering and QA.
- Remove mechanical seal assembly carefully without damaging faces or gaskets.
- Soak removed seal components in detergent solution for 10 minutes.
- Clean all grooves, springs, and dynamic faces using soft brush.
- Rinse with purified water and inspect for residue or wear.
5.4 Reassembly and Drying
- Allow all cleaned parts to air dry in clean, dust-free environment.
- Reassemble the seal and shaft only when all components are verified dry.
- Apply approved lubricant (if required) to O-rings before fitting.
5.5 Verification and Documentation
- QA to inspect cleaned shafts and seals visually for residue, stains, and integrity.
- Document all activities in the Agitator Shaft and Seal Cleaning Logbook (Annexure-1).
- Affix “CLEANED” label on tank or agitator panel after QA approval.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Agitator Shaft and Seal Cleaning Logbook (Annexure-1)
- Disassembly/Reassembly Checklist (if applicable)
8. References
- ICH Q7 – GMP Guidelines
- 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
- WHO TRS 986 Annex 4 – Cleaning Validation
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Agitator Shaft and Seal Cleaning Logbook
| Date | Tank ID | Agitator Type | Cleaning Method | Cleaned By | QA Verified | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | MXR-ELX-10 | Top Mounted | Manual + Soaking | Rajesh Kumar | Sunita Reddy | Seal intact – Cleaned |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Included drying step and lubricant precaution | Process Improvement | QA Head |