Standard Operating Procedure for Cleaning Low Volume Transfer Hoses in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/178/2025 |
| Supersedes | SOP/ELX/178/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To outline the procedure for effective and validated cleaning of low volume transfer hoses used in the manufacturing of elixirs to ensure removal of product residues, cleaning agents, and potential contaminants before reuse.
2. Scope
This SOP applies to all flexible low volume hoses (≤2-inch diameter) used for transferring elixir components, intermediate or final bulk solutions in the Elixir Department.
3. Responsibilities
- Production Operator:
- Perform cleaning activities as per this SOP.
- Ensure hoses are labeled and stored after cleaning.
- QA Officer:
- Verify cleanliness through visual checks and periodic swab/rinse sampling.
- Engineering Department:
- Ensure availability and maintenance of hose cleaning adapters, fittings, and drying units.
4. Accountability
The Production Head is accountable for cleaning and labeling of hoses. The QA Head is responsible for verification and compliance. The Engineering Head ensures supporting utility infrastructure.
5. Procedure
5.1 Preparation
- Ensure hose is disconnected from both ends.
- Verify that the hose is not damaged, cracked, or discolored. If found unsuitable, send for disposal or replacement.
- Attach hose adapters to facilitate cleaning flow from one end to another.
5.2 Cleaning Steps
- Initial Rinse: Flush the hose internally with purified water for at least 3 minutes to remove bulk residues.
- Detergent Wash: Circulate 1% non-ionic or approved cleaning agent solution through the hose using a circulation pump for 5–10 minutes depending on product type and batch size.
- Intermediate Rinse: Rinse the hose thoroughly with purified water until no foam is observed and conductivity is within PW limits.
- Final Rinse: Perform a final rinse with hot purified water (60–80°C) for 3 minutes to remove traces of detergent and enhance drying.
5.3 Drying and Storage
- Connect both ends of the hose to a HEPA-filtered compressed air source to remove internal moisture.
- Alternatively, hang the hose in a dedicated drying cabinet and allow to air dry.
- Once dry, cap both ends with sanitized caps and label as “CLEANED – READY FOR USE.”
- Store the hose in a designated clean area with proper segregation between used and cleaned hoses.
5.4 Cleaning Frequency
- Clean hoses:
- Immediately after each batch use
- Before use if stored beyond validated hold time
5.5 Documentation
- Record all cleaning details in the Hose Cleaning Logbook (Annexure-1).
- Include hose ID, cleaning steps performed, cleaned by, verified by, and date of next due cleaning if applicable.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- PW: Purified Water
- HEPA: High-Efficiency Particulate Air
7. Documents
- Hose Cleaning Logbook (Annexure-1)
- Cleaning Agent Certificate of Analysis
- Swab/Rinse Sampling Report (if applicable)
8. References
- 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
- WHO TRS 986 – Annex 4: GMP for Pharmaceutical Products
- ICH Q7 – GMP Guidelines for APIs
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Hose Cleaning Logbook
| Date | Hose ID | Cleaning Type | Detergent Used | Cleaned By | Verified By | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | HOSE-LV-05 | Batch Use | Neutraclean 1% | Rajesh Kumar | Sunita Reddy | Dry and Labeled |
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 drying procedure and storage labeling | GMP Compliance | QA Head |