Standard Operating Procedure for Handling Bulk Gel Transfer to Filling Area in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/124/2025 |
| Supersedes | SOP/GM/124/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To lay down the procedure for the transfer of bulk gel from the manufacturing vessel to the filling room in a hygienic and controlled manner, maintaining product integrity and avoiding
cross-contamination.
2. Scope
This SOP is applicable to all batches of gel formulations manufactured and transferred to the filling area in the Gel Manufacturing Department.
3. Responsibilities
- Production Operator: Executes the gel transfer as per procedure.
- Supervisor: Ensures all checks are completed before and after transfer.
- QA Officer: Performs line clearance, verifies container labeling and seals.
4. Accountability
Production Manager and Quality Assurance Manager
5. Procedure
5.1 Pre-Transfer Checks
- Ensure the mixing vessel is labeled as “Approved for Transfer.”
- Check line clearance in the filling area and approve through QA.
- Ensure transfer containers (SS containers or IBCs) are clean and labeled.
- Verify integrity of clamps, hoses, tri-clovers, valves, and gaskets.
5.2 Transfer Methods
Bulk gel can be transferred via:
- Gravity Flow: From elevated mixing tank using sanitized silicone hoses.
- Transfer Pump: For viscous gels or long transfer distances.
5.3 Transfer Process
- Connect sanitized transfer line from mixing tank to transfer vessel or directly to filling hopper.
- Start transfer ensuring smooth, bubble-free flow. Avoid air entrapment and overfilling.
- Maintain hygienic conditions during transfer — operators must wear gloves, mask, and gown.
- Upon completion, disconnect the line using aseptic techniques and cover the hose ends.
5.4 Post-Transfer Activities
- Affix “Transferred to Filling” label on transfer container or tank.
- Clean all accessories used during transfer (hoses, pumps, clamps).
- Record transfer details in the logbook.
- QA to verify and sign off the transfer activity.
5.5 Special Instructions
- If transfer exceeds 30 minutes, take sample for microbial monitoring post-transfer.
- Do not use pressurized air for transfer of gels.
6. Abbreviations
- IBC: Intermediate Bulk Container
- QA: Quality Assurance
- SS: Stainless Steel
7. Documents
- Gel Transfer Log – Annexure-1
- Line Clearance Checklist – Annexure-2
- Transfer Equipment Cleaning Log – Annexure-3
8. References
- WHO TRS 986 Annex 2 – GMP Guidelines
- Schedule M – Gel Formulations Handling
- FDA Guidance on Process Validation (Stage 2)
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: Gel Transfer Log
| Date | Batch No. | Tank ID | Transfer Vessel ID | Start Time | End Time | Operator |
|---|---|---|---|---|---|---|
Annexure-2: Line Clearance Checklist
| Check Point | Status (Yes/No) | Remarks |
|---|---|---|
| Filling area cleaned | ||
| Previous batch labels removed | ||
| Line equipment verified | ||
| QA Approval |
Annexure-3: Transfer Equipment Cleaning Log
| Date | Equipment | Cleaning Agent Used | Cleaned By | Verified By (QA) |
|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 14/02/2022 | 1.0 | Initial version | First Issue | QA Head |
| 09/06/2025 | 2.0 | Updated method steps and included cleaning log | Compliance Update | QA Head |