Standard Operating Procedure for Sanitization of Pumps After Use in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/166/2025 |
| Supersedes | SOP/ELX/166/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standard procedure for the proper sanitization of product-contact pumps used in elixir manufacturing after each use to prevent microbial contamination and maintain GMP compliance.
2. Scope
This SOP applies to all centrifugal, peristaltic, and diaphragm pumps used for transferring elixir products, intermediates, or cleaning solutions within the Elixir Department.
3. Responsibilities
- Production Operator:
- Perform pump sanitization as per the defined procedure.
- Ensure all parts are disinfected, dried, and reassembled properly.
- Engineering Department:
- Assist with disassembly or maintenance issues during sanitization.
- QA Department:
- Verify cleaning records, inspect pumps post-sanitization, and approve release.
4. Accountability
The Production Head is accountable for execution and record maintenance. The QA Head ensures verification and release for reuse. Engineering supports mechanical integrity and troubleshooting.
5. Procedure
5.1 Pre-Sanitization Preparation
- Ensure the pump is disconnected
from power and product lines.
Label as “TO BE SANITIZED.”
Wear appropriate PPE: gloves, apron, safety glasses, and mask.
5.2 Cleaning of Pump
- Flush the pump with purified water to remove visible product residues.
- Disassemble the pump components (impeller, housing, hoses) carefully.
- Soak parts in 1% non-ionic detergent solution for 10–15 minutes.
- Brush internal parts using a soft-bristled brush and rinse with purified water.
- Repeat rinsing until the rinse water shows neutral pH and no visible foam.
5.3 Sanitization of Pump
- Prepare freshly diluted sanitizing agent as per approved disinfectant SOP (e.g., 70% IPA, 6% H2O2, or 0.1% peracetic acid).
- Apply sanitizer using:
- Wipe method – for external parts and gaskets
- Circulation method – pump sanitizer through the pump circuit (closed loop if available)
- Ensure sanitizer contact time of at least 10 minutes.
- Allow air drying without rinsing unless disinfectant SOP requires a rinse.
5.4 Reassembly and Storage
- Inspect all pump parts for cleanliness, damage, or wear before reassembly.
- Reassemble the pump ensuring all gaskets are properly seated.
- Label the pump as “SANITIZED” with date and initials.
- Store in a clean, dry, designated area with dust protection.
5.5 Documentation
- Enter sanitization details in Pump Sanitization Logbook (Annexure-1).
- Include date, time, name of operator, sanitizer used, and QA verification.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- IPA: Isopropyl Alcohol
7. Documents
- Pump Sanitization Logbook (Annexure-1)
- Disinfectant Preparation Record
- Swab/Rinse Sampling Report (if applicable)
8. References
- 21 CFR Part 211 – Equipment Cleaning and Maintenance
- WHO TRS 961 – GMP for Pharmaceutical Manufacturing
- 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: Pump Sanitization Logbook
| Date | Pump ID | Sanitizer Used | Contact Time | Performed By | QA Verified | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | PMP-ELX-05 | 70% IPA | 10 min | Rajesh Kumar | Sunita Reddy | Approved for use |
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 circulation sanitization method and storage precautions | Enhanced GMP Practice | QA Head |