SOP Guide for Pharma

Tablets: SOP for Vacuum Transfer Systems in Powder Handling – V 2.0

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Tablets: SOP for Vacuum Transfer Systems in Powder Handling – V 2.0

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

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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

  1. Verify that the vacuum transfer system is clean and free from any residual materials from previous batches.
  2. 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.
  3. Check the system for leaks and ensure that it is sealed tightly to prevent contamination during powder transfer.
  4. Ensure that the vacuum pump is functioning correctly and calibrated according to the manufacturer’s specifications.
  5. 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

  1. Start the vacuum pump and set the system to the required vacuum pressure for powder transfer.
  2. Initiate the transfer of powder into the vacuum system. Ensure that the powder is being transferred without clogging the system or creating excessive dust.
  3. Monitor the transfer process to ensure that the correct amount of powder is being moved, and the system is functioning within the required parameters.
  4. 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.
  5. Periodically inspect the system for any leaks, clogs, or pressure drops that may indicate malfunctioning or contamination risks.
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5.3 Post-Transfer Cleanup

  1. After the powder has been transferred, turn off the vacuum pump and disconnect the system from the collection container.
  2. Ensure that all powder transfer hoses, filters, and equipment are cleaned according to the cleaning SOP to prevent cross-contamination between batches.
  3. 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.
  4. 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

  1. Perform regular inspections and maintenance on the vacuum transfer system, including checking the vacuum pump, filters, seals, and hoses.
  2. Ensure that the vacuum pump is calibrated and maintained according to the manufacturer’s recommendations.
  3. Replace worn or damaged components promptly to avoid compromising the system’s efficiency and safety.
  4. Document all maintenance activities and inspections in the maintenance log (Annexure-1).

5.5 Documentation and Record-Keeping

  1. 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).
  2. Document any deviations from the SOP in the deviation report (Annexure-3), along with corrective actions taken.
  3. Ensure that all maintenance activities, including calibration, repairs, and inspections, are documented and tracked in the maintenance log (Annexure-1).
  4. Store all records according to the document retention policy for future reference, audits, and regulatory inspections.
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6. Abbreviations

7. Documents

  1. Batch Record (Annexure-2)
  2. Deviation Report (Annexure-3)
  3. Maintenance Log (Annexure-1)

8. References

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
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