Standard Operating Procedure for Vacuum Transfer Systems in Powder Handling
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/040/2025 |
| Supersedes | SOP/TAB/040/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 27/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 27/08/2026 |
1. Purpose
This SOP outlines the procedure for using vacuum transfer systems in the handling of powders during tablet manufacturing. The use of vacuum systems ensures the efficient, hygienic, and safe transfer of powders between different stages of the manufacturing process while minimizing dust exposure and contamination.
2. Scope
This SOP applies to all tablet manufacturing processes that involve the transfer of powders, including API (Active Pharmaceutical Ingredients), excipients, and intermediate products. The procedure covers the use of vacuum transfer systems to move powders within the facility, including receiving, blending, and tablet compression stages.
3. Responsibilities
- Manufacturing Personnel: Responsible for setting up and operating the vacuum transfer system and ensuring that the system is used according to this SOP to prevent contamination and powder loss.
- Quality Control (QC): Responsible for ensuring that all vacuum transfer systems meet cleanliness standards, are calibrated, and that powder handling is done in compliance with GMP.
- Maintenance Personnel: Responsible for the regular inspection, maintenance, and troubleshooting of the vacuum transfer systems to ensure they operate effectively and safely.
- Quality Assurance (QA): Ensures that the vacuum transfer system is validated and meets operational standards. Also, reviews any deviations in the powder handling process and approves corrective actions.
4. Accountability
The Production Manager is accountable for overseeing the proper functioning and use of the vacuum transfer systems in the manufacturing process. The QA Manager is responsible for ensuring compliance with the established procedures and reviewing any deviations or corrective actions.
5. Procedure
5.1 Pre-Use Setup
- Verify that the vacuum transfer system is clean and free from any residual materials from previous batches.
- Ensure that all components of the vacuum transfer system, including hoses, filters, and collection containers, are in good condition and free from cracks or damage.
- Check the system for leaks and ensure that it is sealed tightly to prevent contamination during powder transfer.
- Ensure that the vacuum pump is functioning correctly and calibrated according to the manufacturer’s specifications.
- Confirm that the system is connected to the appropriate collection containers for powder storage or further processing, such as blending or compression machines.
5.2 Powder Transfer Process
- Start the vacuum pump and set the system to the required vacuum pressure for powder transfer.
- Initiate the transfer of powder into the vacuum system. Ensure that the powder is being transferred without clogging the system or creating excessive dust.
- Monitor the transfer process to ensure that the correct amount of powder is being moved, and the system is functioning within the required parameters.
- If transferring powders from multiple containers, ensure that the correct powders are being transferred to the appropriate mixing or processing equipment, following the batch instructions.
- Periodically inspect the system for any leaks, clogs, or pressure drops that may indicate malfunctioning or contamination risks.
5.3 Post-Transfer Cleanup
- After the powder has been transferred, turn off the vacuum pump and disconnect the system from the collection container.
- Ensure that all powder transfer hoses, filters, and equipment are cleaned according to the cleaning SOP to prevent cross-contamination between batches.
- Inspect all system components for any residual powder or contamination. Use a vacuum or compressed air to remove any remaining powder from the system before disassembly.
- Store the vacuum transfer system components in a clean, dry environment to prevent powder buildup and ensure readiness for future use.
5.4 Equipment Inspection and Maintenance
- Perform regular inspections and maintenance on the vacuum transfer system, including checking the vacuum pump, filters, seals, and hoses.
- Ensure that the vacuum pump is calibrated and maintained according to the manufacturer’s recommendations.
- Replace worn or damaged components promptly to avoid compromising the system’s efficiency and safety.
- Document all maintenance activities and inspections in the maintenance log (Annexure-1).
5.5 Documentation and Record-Keeping
- Record all powder transfer activities, including system settings, powder types, transfer quantities, and any issues encountered during the process, in the batch record (Annexure-2).
- Document any deviations from the SOP in the deviation report (Annexure-3), along with corrective actions taken.
- Ensure that all maintenance activities, including calibration, repairs, and inspections, are documented and tracked in the maintenance log (Annexure-1).
- Store all records according to the document retention policy for future reference, audits, and regulatory inspections.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-3)
- Maintenance Log (Annexure-1)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Maintenance Log
| Maintenance Date | Equipment Name | Inspection Details | Action Taken | Next Inspection Date |
|---|---|---|---|---|
| 15/07/2025 | Vacuum Transfer Pump | Checked for leaks, calibrated | No issues found | 15/01/2026 |
Annexure-2: Batch Record
| Batch Number | Powder Type | Quantity Transferred | Transfer Time | Comments |
|---|---|---|---|---|
| Batch 001 | API | 50 kg | 15 min | Successful transfer |
Annexure-3: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 20/07/2025 | Batch 002 | Vacuum pressure dropped during transfer | Adjusted vacuum pump settings | John Doe |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated Vacuum System Specifications | Improved Process Efficiency | QA Head |