Standard Operating Procedure for Vacuum Transfer Systems in Powder Handling

Department	Tablet
SOP No.	SOP/TAB/046/2025
Supersedes	SOP/TAB/046/2022
Page No.	Page 1 of 6
Issue Date	01/10/2025
Effective Date	06/10/2025
Review Date	01/10/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for using vacuum transfer systems during powder handling in tablet manufacturing. The vacuum transfer system is used to safely and efficiently transfer powders while minimizing contamination, exposure to the operators, and dust generation.

2. Scope

This SOP applies to the handling, transfer, and processing of powders within the tablet manufacturing facility. It covers the setup, operation, and maintenance of the vacuum transfer system used during blending, granulation, and tablet compression processes.

3. Responsibilities

• Manufacturing Personnel: Responsible for ensuring proper operation of the vacuum transfer system during powder handling and following this SOP to avoid contamination or dust generation.
• Quality Control (QC): Responsible for verifying that the vacuum transfer system is working as intended and that powders are being transferred in a contamination-free manner. Also, responsible for ensuring that the system meets cleanliness standards.
• Maintenance Team: Responsible for regular inspection, maintenance, and calibration of the vacuum transfer system to ensure it is functioning efficiently and effectively.

4. Accountability

The Production Manager is accountable for ensuring that all personnel are trained and comply with this SOP during powder handling. The QA Manager is responsible for ensuring that the vacuum transfer system meets the required quality standards and that the procedure is being followed correctly.

5. Procedure

5.1 Pre-Transfer Setup

1. Ensure that the vacuum transfer system is clean and free from any residual material. Perform a thorough inspection before use.
2. Check all system components, including vacuum pumps, filters, hoses, and collection containers, to ensure they are in proper working condition.
3. Verify that the material to be transferred is compatible with the system, ensuring that the material can be handled safely and efficiently by the vacuum transfer system.
4. Confirm that the vacuum system is properly connected and calibrated, with the correct airflow settings and adequate suction force.

5.2 Operation of Vacuum Transfer System

1. Before starting the transfer, ensure that all personnel are wearing appropriate personal protective equipment (PPE), including gloves and masks, to prevent exposure to hazardous powders.
2. Activate the vacuum system, ensuring that the system reaches the required suction level for effective powder transfer.
3. Begin transferring the powder into the designated hopper or container. Ensure that the powder flows smoothly through the vacuum system without any blockages or excessive dust generation.
4. Monitor the system throughout the transfer process. Ensure that no powder leakage occurs from the system, and make sure that the hose connections remain secure.
5. If any issues, such as a clog or loss of suction, are detected, stop the process immediately and troubleshoot the system before continuing with the transfer.

5.3 Dust Control during Transfer

1. Ensure that the vacuum transfer system is equipped with appropriate dust collection filters to capture airborne particles during powder transfer.
2. Monitor the filter system regularly and check for any signs of clogging or reduced performance. Clean or replace filters as needed to maintain effective dust control.
3. In areas where higher levels of dust are generated, consider using additional localized exhaust systems to capture dust before it disperses into the environment.

5.4 Post-Transfer Cleanup

1. After the transfer is complete, disconnect the vacuum transfer system from the material container and clean all surfaces that came into contact with the powder.
2. Clean the hoses, filters, and collection containers according to the equipment cleaning SOP to prevent cross-contamination between batches.
3. Inspect the system for any damage or wear, and perform any necessary repairs or replacements to ensure continued efficient operation for future transfers.

5.5 Equipment Maintenance

1. Perform regular inspections of the vacuum transfer system as per the maintenance schedule to ensure that all components, such as hoses, vacuum pumps, and filters, are functioning correctly.
2. Check for leaks, blockages, or wear on hoses and seals, and replace any damaged components immediately.
3. Ensure that the vacuum system is calibrated regularly to maintain optimal suction power and airflow.
4. Document all maintenance activities, including the date, personnel involved, and any corrective actions taken, in the maintenance log (Annexure-1).

5.6 Monitoring and Documentation

1. Record all details of the powder transfer process, including system settings (e.g., suction pressure, flow rate) and any deviations from the standard operating procedure, in the batch record (Annexure-2).
2. Ensure that any deviations are promptly documented in the deviation report (Annexure-3), along with corrective actions taken to address the issue.
3. Maintain records of all equipment inspections, calibration, and maintenance activities for future audits and regulatory reviews.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Batch Record (Annexure-2)
2. Deviation Report (Annexure-3)
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	System Component	Maintenance Type	Performed By	Comments
10/09/2025	Vacuum Pump	Filter Cleaning	John Doe	Filter cleaned and recalibrated
12/09/2025	Hoses	Inspection and Replacement	Jane Smith	Replaced worn-out hoses

Annexure-2: Batch Record

Batch Number	Tablet Type	Transfer Parameters	Dust Control	Comments
Batch 001	Tablet A	Suction Pressure: 50 psi	Dust extraction system active	No deviations
Batch 002	Tablet B	Suction Pressure: 45 psi	Dust extraction system active	Minor delay in transfer

Annexure-3: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/09/2025	Batch 003	Low suction pressure during transfer	Increased vacuum pressure	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 Transfer Parameters	Improved Efficiency	QA Head