Standard Operating Procedure for Cleaning of Utility Pipelines Used in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/113/2025 |
| Supersedes | SOP/ELX/113/2022 |
| 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 standard procedure for cleaning utility pipelines such as those used for Purified Water (PW), Steam, Compressed Air, and WFI lines in elixir manufacturing to ensure compliance with GMP and to prevent contamination or cross-contamination.
2. Scope
This SOP applies to all utility service pipelines connected to mixing vessels, transfer lines, and other manufacturing equipment within the Elixir Department.
3. Responsibilities
- Maintenance Technician:
- Perform cleaning operations and document activity.
- Production Operator:
- Support cleaning by ensuring lines are empty and isolated.
- QA Officer:
- Review cleaning records and verify cleanliness visually or via swab/rinse testing if applicable.
4. Accountability
The Engineering Head is accountable for the proper execution and documentation of utility line cleaning, and ensuring their readiness for manufacturing.
5. Procedure
5.1 Identification of Pipelines
- Refer
to the pipeline schematic to identify relevant lines used for:
Tag lines requiring cleaning as per cleaning schedule or batch-specific instruction.
- Purified Water (PW)
- Water for Injection (WFI)
- Steam (Clean/Plant)
- Compressed Air
5.2 Pre-Cleaning Checks
- Ensure isolation of the line from main utility source.
- Drain any residual product or utility from the pipeline.
- Wear appropriate PPE and display “Under Maintenance” signage in the area.
5.3 Cleaning Methodology
- Purified Water/WFI Lines:
- Flush with hot WFI or sanitizing agent (as applicable) followed by a purified water rinse.
- Ensure final rinse has conductivity within acceptable limits.
- Steam Lines:
- Flush with clean steam through all valves and condensate drain points.
- Ensure condensate is clear and free from particulates or discoloration.
- Compressed Air Lines:
- Purge using filtered compressed air.
- Check for oil carryover and microbial load (if applicable).
5.4 Post-Cleaning Verification
- Visually inspect all accessible ports, valves, and ends.
- Conduct rinse or swab test based on risk assessment and applicable validation protocol.
- Record cleaning parameters and sampling results in the Utility Cleaning Log (Annexure-1).
5.5 Reconnection and Readiness
- Reconnect cleaned pipelines and test for integrity (leak check and pressure test).
- Label line as “CLEANED” and update status board in the production area.
6. Abbreviations
- SOP: Standard Operating Procedure
- WFI: Water for Injection
- PW: Purified Water
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Utility Pipeline Cleaning Log (Annexure-1)
- Pipeline Layout and Identification Chart
- Cleaning Validation Protocol (if applicable)
8. References
- WHO TRS 1010 – Good Manufacturing Practices
- ISPE Baseline Guide Vol. 6 – GEP for Utilities
- 21 CFR Part 211.67 – Equipment and Utility Maintenance
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Utility Pipeline Cleaning Log
| Date | Line ID | Utility Type | Cleaning Method | Final Rinse/Flush Result | Cleaned By | QA Verified |
|---|---|---|---|---|---|---|
| 11/04/2025 | PW-07 | Purified Water | Hot WFI Flush | Conductivity: 1.2 µS/cm | Rajesh Kumar | Sunita Reddy |
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 | Added cleaning verification and labeling | Enhanced Compliance | QA Head |