Standard Operating Procedure for Rinsing Procedure Using Purified Water in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/168/2025 |
| Supersedes | SOP/ELX/168/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To provide a standard procedure for effective rinsing of cleaned equipment, utensils, and product contact surfaces using Purified Water (PW), ensuring removal of cleaning agents and residual materials in compliance with cGMP standards.
2. Scope
This SOP applies to all product-contact equipment and accessories including mixing vessels, pipelines, transfer hoses, filters, and filling units in the Elixir Department that require rinsing with Purified Water post-cleaning.
3. Responsibilities
- Production Operator:
- Perform rinsing operations as per defined procedure.
- Ensure adequate flushing and record all parameters.
- Engineering Department:
- Ensure continuous supply and pressure of Purified Water within the required specifications.
- QA Department:
- Verify rinsing records and perform sampling as needed to confirm rinsing effectiveness.
4. Accountability
The Production Head is accountable for correct execution and documentation. QA Head is responsible for verification and compliance review. Engineering ensures uninterrupted availability of PW.
5. Procedure
5.1 Pre-Rinsing Checks
- Ensure cleaning has been completed and verified for the respective equipment or accessory.
- Inspect the integrity of PW supply lines and points of use (POUs).
- Flush the PW outlet for at least 1 minute prior to use to remove stagnant water.
5.2 Rinsing Procedure
- Use sanitized hoses or spray guns connected to PW line for rinsing.
- Start from top surfaces and proceed downward to avoid recontamination.
- Rinse:
- Internal surfaces of tanks for 3–5 minutes or until rinse water is visibly clear.
- Transfer hoses and filling lines for minimum of 2 minutes or until conductivity matches system PW.
- For pipelines, connect CIP loop (if available) and circulate PW for validated duration.
- Ensure all detergent residues are removed by checking the pH of rinse water (acceptable range: 5.0–7.5).
5.3 Post-Rinsing Steps
- Drain remaining water from equipment using gravity or compressed air (filtered through 0.22 µm).
- Label rinsed equipment as “RINSED – Pending QA Approval.”
- Collect final rinse samples for TOC, conductivity, and microbial limits if required.
5.4 Documentation
- Record rinsing activity in the Rinsing Logbook (Annexure-1).
- QA shall verify and sign off before releasing equipment for next batch use.
6. Abbreviations
- SOP: Standard Operating Procedure
- PW: Purified Water
- QA: Quality Assurance
- POU: Point of Use
- TOC: Total Organic Carbon
7. Documents
- Rinsing Logbook (Annexure-1)
- Purified Water Quality Certificate
- Cleaning Verification Records
8. References
- 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
- WHO TRS 937 Annex 4 – Good Practices for Pharmaceutical Water Systems
- ICH Q7 – Good Manufacturing Practice 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: Rinsing Logbook
| Date | Equipment ID | Duration (min) | pH of Final Rinse | Performed By | QA Verified | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | MXR-ELX-07 | 5 | 6.7 | Rajesh Kumar | Sunita Reddy | Compliant |
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 TOC testing and pre-flush of PW line | Audit Compliance | QA Head |