Standard Operating Procedure for Cleaning After Batch Completion in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/070/2025 |
| Supersedes | SOP/ELX/070/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a procedure for thorough and validated cleaning of all equipment and accessories used in the elixir manufacturing process after completion of a batch to prevent cross-contamination and ensure GMP compliance.
2. Scope
This SOP applies to the cleaning of all equipment such as mixing vessels, storage tanks, pipelines, transfer hoses, utensils, and accessories used in the Elixir Department after completion of batch processing.
3. Responsibilities
- Production Operator:
- Perform cleaning as per the defined steps and record details in the cleaning log.
- Production Supervisor:
- Ensure cleaning activities are performed correctly and cleaning is visually verified.
- QA Officer:
- Conduct line clearance and approve cleaned equipment for the next batch.
4. Accountability
The Production Head is accountable for ensuring that cleaning activities are properly executed, documented, and verified before the start of a new batch.
5. Procedure
5.1 Initial Cleaning Preparation
- Switch off all equipment and disconnect utilities before cleaning.
- Wear appropriate PPE including gloves, goggles, and aprons.
- Place “Under Cleaning” tags on equipment before starting.
5.2 Equipment Disassembly
- Dismantle removable parts such as agitator blades, sampling valves, manhole covers, and transfer hoses.
- Rinse each part with potable water to remove residual product.
5.3 Cleaning Procedure
- Prepare 2% non-ionic cleaning solution or approved detergent.
- Scrub internal and external surfaces with the solution using lint-free cloths or brushes.
- Rinse thoroughly with potable water followed by purified water until no detergent residue is observed.
- Visually inspect all surfaces for cleanliness and absence of stains or residues.
5.4 Drying
- Allow cleaned parts to air dry in a designated drying area or dry with clean compressed air.
- Ensure drying is complete before reassembly.
5.5 Reassembly and Inspection
- Reassemble equipment after complete drying.
- Conduct visual inspection and document in the Equipment Cleaning Record (Annexure-1).
5.6 Line Clearance
- Submit the cleaned equipment for QA inspection.
- QA to verify cleanliness, label as “CLEANED,” and provide line clearance in the Line Clearance Record (Annexure-2).
6. Abbreviations
- SOP: Standard Operating Procedure
- PPE: Personal Protective Equipment
- QA: Quality Assurance
7. Documents
- Equipment Cleaning Record (Annexure-1)
- Line Clearance Record (Annexure-2)
- Cleaning Checklist (Annexure-3)
8. References
- 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
- WHO GMP Guidelines – 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: Equipment Cleaning Record
| Date | Equipment ID | Cleaning Agent | Cleaned By | Verified By | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | MXV-04 | 2% Detergent | Rajesh Kumar | Sunita Reddy | No residues |
Annexure-2: Line Clearance Record
| Date | Equipment ID | Inspected By | Status | Remarks |
|---|---|---|---|---|
| 11/04/2025 | MXV-04 | Sunita Reddy | Cleared | Ready for next batch |
Annexure-3: Cleaning Checklist
| Area | Cleaned (Yes/No) | Checked By | Remarks |
|---|---|---|---|
| Inner Tank Surface | Yes | Sunita Reddy | Spotless |
| Agitator Blade | Yes | Sunita Reddy | No residue |
| Inlet Valve | Yes | Sunita Reddy | Clean |
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 | Added Detailed Checklist and QA Line Clearance | GMP Alignment | QA Head |