Standard Operating Procedure for Transfer of Bulk Elixir to Storage Tank
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/080/2025 |
| Supersedes | SOP/ELX/080/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for the safe, hygienic, and GMP-compliant transfer of bulk elixir solution from the manufacturing vessel to a designated storage tank prior to filtration, filling, or further processing.
2. Scope
This SOP applies to all batch-wise transfers of bulk elixir solution to intermediate or final storage tanks within the Elixir Department.
3. Responsibilities
- Production Operator:
- Perform cleaning verification, connect hoses, monitor transfer, and maintain records.
- Production Supervisor:
- Ensure the storage tank is cleaned, labeled, and approved by QA before transfer.
- Verify batch details and supervise the entire transfer process.
- QA Officer:
- Approve cleanliness of equipment and line clearance before transfer initiation.
4. Accountability
The Head of Production is accountable for ensuring the correct execution, documentation, and compliance of the bulk transfer activity.
5. Procedure
5.1 Pre-Transfer Checks
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Verify that the target storage tank is labeled as “CLEANED” and approved by QA.
Confirm the manufacturing vessel contains the approved bulk elixir and is labeled with the correct batch number.
Inspect and sanitize transfer hoses and connections using 70% IPA.
Ensure all valves are closed before connection and that nitrogen blanketing (if required) is initiated.
5.2 Transfer Operation
- Connect the sanitized hose from the manufacturing vessel outlet to the storage tank inlet under closed conditions.
- Open the outlet valve gradually to allow smooth flow and prevent splashing or foaming.
- Monitor the flow throughout the transfer and avoid interruptions or air entrapment.
- Record start and end times of the transfer.
5.3 Post-Transfer Activities
- Close all valves after transfer is complete and disconnect the hose carefully.
- Seal all openings and label the storage tank with:
- Product Name
- Batch Number
- Volume
- “UNDER STORAGE” Status
- Clean and store all accessories used in the transfer in designated areas.
5.4 Documentation
- Enter the transfer details in the Bulk Transfer Log (Annexure-1).
- Ensure the entry is reviewed and signed by the Production Supervisor and QA.
- Attach the record to the respective BMR.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- IPA: Isopropyl Alcohol
7. Documents
- Bulk Transfer Log (Annexure-1)
- Storage Tank Status Label (Annexure-2)
- BMR – Transfer Section
8. References
- 21 CFR Part 211.80 – Holding and Distribution
- WHO TRS 986 – GMP Guidelines 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: Bulk Transfer Log
| Date | Batch No. | Start Time | End Time | Volume Transferred | Operator | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1019 | 10:15 AM | 11:00 AM | 450 Litres | Rajesh Kumar | No issues observed |
Annexure-2: Storage Tank Status Label
| Field | Example Entry |
|---|---|
| Product Name | Paracetamol Elixir |
| Batch No. | ELX-1019 |
| Volume | 450 Litres |
| Status | UNDER STORAGE |
| Storage Tank No. | ST-02 |
| Date | 11/04/2025 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Issue | New SOP | QA Head |
| 11/04/2025 | 2.0 | Included Storage Tank Labeling and Safety Precautions | Compliance with QA Observations | QA Head |