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

1. Ensure the mixing vessel is labeled as “Approved for Transfer.”
2. Check line clearance in the filling area and approve through QA.
3. Ensure transfer containers (SS containers or IBCs) are clean and labeled.
4. 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

1. Connect sanitized transfer line from mixing tank to transfer vessel or directly to filling hopper.
2. Start transfer ensuring smooth, bubble-free flow. Avoid air entrapment and overfilling.
3. Maintain hygienic conditions during transfer — operators must wear gloves, mask, and gown.
4. Upon completion, disconnect the line using aseptic techniques and cover the hose ends.

5.4 Post-Transfer Activities

1. Affix “Transferred to Filling” label on transfer container or tank.
2. Clean all accessories used during transfer (hoses, pumps, clamps).
3. Record transfer details in the logbook.
4. 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

1. Gel Transfer Log – Annexure-1
2. Line Clearance Checklist – Annexure-2
3. 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