Standard Operating Procedure for Cleaning and Sanitization of Storage Vessels in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/082/2025 |
| Supersedes | SOP/ELX/082/2022 |
| 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 validated procedure for the cleaning and sanitization of storage vessels used in the Elixir Department to ensure removal of product residues, prevent cross-contamination, and maintain microbial control.
2. Scope
This SOP applies to all portable and fixed stainless-steel storage vessels used to hold intermediate or final bulk elixir formulations prior to filtration or packaging.
3. Responsibilities
- Production Operator:
- Perform cleaning and sanitization as per procedure and document all activities.
- Production Supervisor:
- Verify vessel cleaning status and ensure tagging is correctly updated.
- QA Officer:
- Review cleaning log and visually inspect vessel prior to next use.
4. Accountability
The Head of Production is accountable for ensuring that all storage vessels are cleaned and sanitized according to this SOP and that records are complete and accurate.
5. Procedure
5.1 Cleaning Frequency
- Clean the storage vessel:
- Immediately after batch transfer/use
- Before use if not used within 72 hours of last cleaning
- After any suspected contamination event
5.2 Cleaning Procedure
- Ensure the vessel is disconnected from all inlet/outlet hoses and emptied completely.
- Rinse vessel with potable water to remove gross residues.
- Scrub interior surfaces using soft-bristle brush with 2% non-ionic detergent solution.
- Rinse thoroughly with potable water followed by purified water until rinse water is clear.
- Visually inspect for any remaining residue. Repeat cleaning if needed.
5.3 Sanitization Procedure
- Prepare 0.1% v/v sodium hypochlorite solution or any approved sanitizing agent.
- Circulate or spray the solution throughout the vessel for 10–15 minutes ensuring full surface contact.
- Drain and rinse the vessel with Water for Injection (WFI) to remove sanitizer residue.
- Allow vessel to air dry in a clean area or wipe with sterile lint-free cloth if required.
5.4 Post-Cleaning Activities
- Label the cleaned vessel with a “CLEANED” status tag (Annexure-1).
- Record cleaning and sanitization details in the Cleaning Logbook (Annexure-2).
- Ensure cleaning validation data is attached, where applicable.
5.5 Precautions
- Use dedicated scrubbers and accessories per vessel.
- Use protective gloves and goggles during chemical handling.
- Never mix cleaning agents or sanitizers unless validated for compatibility.
6. Abbreviations
- SOP: Standard Operating Procedure
- WFI: Water for Injection
- QA: Quality Assurance
7. Documents
- Cleaned Vessel Tag (Annexure-1)
- Cleaning Logbook (Annexure-2)
- Cleaning Validation Report (where applicable)
8. References
- 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
- WHO TRS 986 – GMP for Pharmaceuticals
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleaned Vessel Tag
| Tank ID | Product Last Processed | Cleaned By | Cleaning Date | Status |
|---|---|---|---|---|
| ST-02 | Paracetamol Elixir | Rajesh Kumar | 11/04/2025 | CLEANED |
Annexure-2: Cleaning Logbook
| Date | Tank ID | Batch No. | Cleaned By | Sanitized By | QA Verified | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | ST-02 | ELX-1021 | Rajesh Kumar | Sunita Reddy | Yes | Approved for reuse |
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 sanitization steps and validation reference | GMP Compliance | QA Head |