Standard Operating Procedure for Final Mixing Tank Clean-in-Place (CIP) Operations
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/100/2025 |
| Supersedes | SOP/ELX/100/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To describe the procedure for automated Clean-in-Place (CIP) of the final mixing tank used in elixir manufacturing, ensuring effective removal of product residues and microbial contaminants.
2. Scope
This SOP is applicable to the CIP of final mixing tanks with fixed spray balls or CIP ports in the Elixir Department after batch completion and prior to the next use.
3. Responsibilities
- Production Operator:
- Execute CIP cycle as per protocol and monitor parameters.
- Record observations and cleaning parameters.
- Production Supervisor:
- Verify tank status and review CIP records.
- QA Officer:
- Ensure CIP effectiveness is validated and samples are within acceptance limits.
4. Accountability
The Head of Production is accountable for proper execution, validation, and documentation of all Clean-in-Place activities for final mixing tanks.
5. Procedure
5.1 Pre-CIP Checks
- Ensure batch transfer is complete and
the tank is declared “Empty”.
Close all drain valves and ensure spray balls are intact and functional.
Place “Under Cleaning” status label on the tank.
5.2 CIP Cycle Description
- Pre-rinse: Use ambient temperature purified water for 5–10 minutes to remove loose residues.
- Detergent wash: Circulate 2% non-ionic detergent solution at 60°C for 15–20 minutes.
- Intermediate rinse: Rinse with purified water until detergent traces are removed (conductivity check below 1.3 μS/cm).
- Sanitization: Circulate 0.1% peracetic acid or 70% IPA solution for 10 minutes (if applicable).
- Final rinse: Rinse with purified water for 5 minutes to remove sanitizing agent.
5.3 Monitoring Parameters
- Record temperature, flow rate, cycle duration, and conductivity during each CIP phase.
- Use automated CIP panel or manual instruments as applicable.
- Attach CIP Parameter Log (Annexure-1) to the BMR.
5.4 Post-CIP Verification
- Visually inspect tank interior using inspection lamp and manhole access.
- Collect rinse water sample for microbiological and chemical residue testing.
- Tank shall be labeled “CLEANED” only after satisfactory QC release.
5.5 Documentation
- Record each step in the CIP Checklist and Log Sheet (Annexure-2).
- Ensure operator and supervisor sign off on completion.
- Attach logs with the corresponding BMR.
6. Abbreviations
- CIP: Clean-in-Place
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- QC: Quality Control
7. Documents
- CIP Parameter Log (Annexure-1)
- CIP Checklist and Log Sheet (Annexure-2)
- Batch Manufacturing Record (BMR)
8. References
- WHO TRS 986 – GMP for Pharmaceutical Products
- 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
- ISPE Baseline Guide Vol 5 – Commissioning and Qualification
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: CIP Parameter Log
| Date | Batch No. | Step | Temp (°C) | Flow Rate (L/min) | Conductivity (μS/cm) | Duration (min) | Operator |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1039 | Detergent Wash | 60 | 80 | NA | 15 | Rajesh Kumar |
Annexure-2: CIP Checklist and Log Sheet
| Step | Completed (Yes/No) | Initials | Date/Time | Remarks |
|---|---|---|---|---|
| Pre-Rinse | Yes | RK | 11/04/2025 09:00 | – |
| Detergent Cycle | Yes | RK | 11/04/2025 09:15 | – |
| Final Rinse | Yes | RK | 11/04/2025 09:45 | Clear water |
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 | Expanded steps and added sanitization option | Process Optimization | QA Head |