Standard Operating Procedure for Cleaning of Gel Transfer Vessels in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/125/2025 |
| Supersedes | SOP/GM/125/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To lay down the procedure for cleaning stainless steel (SS) vessels and containers used for the transfer of bulk gels in the Gel Manufacturing area, to ensure cleanliness and prevent cross-contamination.
2. Scope
This SOP is applicable to all gel transfer vessels
and containers used in the Gel Manufacturing Department after every batch transfer or as required.
3. Responsibilities
- Production Operator: Performs cleaning as per approved procedure.
- Production Supervisor: Ensures correct execution and documentation.
- QA Officer: Verifies and approves cleaning status before reuse.
4. Accountability
Production Head and Quality Assurance Head
5. Procedure
5.1 Pre-Cleaning Preparation
- Ensure the vessel is empty and affixed with “To Be Cleaned” label.
- Wear appropriate PPE including gloves, mask, goggles, and apron.
- Check for residual product; scrape off if necessary using sterile spatula.
5.2 Cleaning Steps
- Rinse the internal and external surfaces of the vessel with Purified Water (PW) to remove gross residue.
- Prepare 2% v/v cleaning agent (e.g., non-ionic detergent) solution in warm water.
- Scrub the inner and outer surfaces using a soft brush dedicated to vessel cleaning.
- Rinse thoroughly with potable water followed by PW until no detergent residue remains (check pH of final rinse).
- Perform final rinse using Water for Injection (WFI) if applicable for product type.
- Invert the vessel on a draining stand and allow to dry in a designated clean area.
5.3 Post-Cleaning Verification
- Visually inspect all internal surfaces under white light for cleanliness.
- Record visual inspection results in the Cleaning Log.
- Affix “Cleaned” status label with date, time, and operator initials.
5.4 Cleaning Frequency
- After each batch transfer or product changeover.
- Before vessel reuse if idle for more than 48 hours.
- After maintenance or repair activity.
6. Abbreviations
- PPE: Personal Protective Equipment
- PW: Purified Water
- WFI: Water for Injection
- QA: Quality Assurance
7. Documents
- Cleaning Log of Transfer Vessels – Annexure-1
- Visual Inspection Checklist – Annexure-2
8. References
- WHO TRS 986 – GMP for Pharmaceutical Products
- FDA 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Cleaning Log of Transfer Vessels
| Date | Vessel ID | Cleaning Agent Used | Cleaned By | Inspected By | Status |
|---|---|---|---|---|---|
| Cleaned/Rejected |
Annexure-2: Visual Inspection Checklist
| Check Point | Status (Yes/No) | Remarks |
|---|---|---|
| Residue-free surface | ||
| No discoloration or stains | ||
| No corrosion or pitting | ||
| Label applied |
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 12/03/2022 | 1.0 | Initial version | New SOP | QA Head |
| 09/06/2025 | 2.0 | Updated cleaning validation and rinse criteria | Annual GMP Review | QA Head |