Standard Operating Procedure for Reducing Dust Generation in Tablet Manufacturing

Department	Tablet
SOP No.	SOP/TAB/045/2025
Supersedes	SOP/TAB/045/2022
Page No.	Page 1 of 6
Issue Date	21/09/2025
Effective Date	26/09/2025
Review Date	21/09/2026

1. Purpose

The purpose of this SOP is to provide guidelines for reducing dust generation during tablet manufacturing. Dust can pose risks to worker health, compromise product quality, and lead to inefficiencies in the manufacturing process. This SOP aims to minimize dust exposure and improve the overall manufacturing environment.

2. Scope

This SOP applies to all stages of tablet manufacturing that generate dust, including blending, granulation, and compression. It covers procedures to control dust generation through equipment setup, process adjustments, and environmental controls.

3. Responsibilities

• Manufacturing Personnel: Responsible for implementing dust control measures during tablet manufacturing, including proper handling of materials and equipment according to this SOP.
• Quality Control (QC): Responsible for monitoring dust levels during the manufacturing process and verifying compliance with dust control standards.
• Quality Assurance (QA): Ensures that dust control measures are followed and that the manufacturing environment is maintained in accordance with GMP requirements.
• Maintenance Personnel: Responsible for ensuring that all dust control equipment, such as dust extraction systems, is properly maintained and functioning.

4. Accountability

The Production Manager is accountable for ensuring that dust generation is minimized during tablet manufacturing. The QA Manager is responsible for verifying that dust control procedures are adhered to and for reviewing records of dust control activities.

5. Procedure

5.1 Pre-Manufacturing Setup

1. Ensure that all tablet manufacturing equipment, including granulators, blenders, and tablet presses, is properly cleaned and maintained to minimize dust accumulation.
2. Verify that the dust collection and extraction systems are installed, functional, and appropriately sized for the manufacturing equipment in use.
3. Ensure that all materials, including powders and excipients, are handled in ways that minimize dust generation, such as using dust-tight containers or transferring powders in enclosed systems.
4. Check that the manufacturing environment has adequate ventilation and is free of any obstructions that could impede airflow.

5.2 During the Manufacturing Process

1. Monitor the manufacturing area for visible dust accumulation. If dust is detected, stop the process immediately and identify the source of the dust.
2. Maintain equipment speeds at optimal settings to avoid excessive dust generation. Adjust settings, such as mixing speed and granulation airflow, to reduce dust formation.
3. Use dust extraction systems (e.g., vacuum hoppers, air filters) during operations where dust is generated, such as during powder transfer, blending, or tablet compression.
4. Ensure that any dust created during the process is quickly captured by the dust extraction system and not allowed to disperse into the work environment.
5. Consider using wet methods (e.g., wet granulation or spraying during blending) when appropriate to reduce airborne dust during manufacturing processes.

5.3 Post-Manufacturing Cleanup

1. After the batch is complete, immediately clean the manufacturing equipment to remove any residual dust. Use appropriate cleaning methods, such as vacuum cleaning or wet wiping, to ensure that no dust is left behind in the equipment.
2. Inspect the manufacturing area for any dust buildup. Clean floors and surfaces using a vacuum or dust control wipes to prevent dust accumulation.
3. Ensure that all dust collected during the cleaning process is properly disposed of in sealed containers to prevent cross-contamination or environmental contamination.

5.4 Equipment Maintenance

1. Inspect and maintain dust collection and extraction equipment regularly to ensure its continued efficiency. This includes checking filters, hoses, and vacuum systems.
2. Replace any worn or damaged equipment components immediately to avoid reduced dust collection performance.
3. Calibrate dust collection equipment as needed to ensure that it is functioning at peak efficiency and capturing dust at the appropriate rate.

5.5 Monitoring and Documentation

1. Monitor dust levels in the manufacturing area regularly using dust detection equipment (e.g., particle counters, dust meters) to ensure that they remain below the established limits for safety and product quality.
2. Document all dust control activities, including equipment settings, maintenance logs, and monitoring results, in the batch record (Annexure-1).
3. Record any deviations or issues related to dust control in the deviation report (Annexure-2), along with the corrective actions taken.

5.6 Employee Training

1. Provide training to all personnel involved in tablet manufacturing on the importance of dust control, how to handle materials safely to minimize dust generation, and how to use dust control equipment.
2. Ensure that employees are aware of the potential health hazards associated with dust exposure and understand how to use personal protective equipment (PPE), such as dust masks, when necessary.

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-1)
2. Deviation Report (Annexure-2)

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: Batch Record

Batch Number	Tablet Type	Dust Control Methods	Monitoring Results	Comments
Batch 001	Tablet A	Vacuum cleaning, closed powder transfer	Dust levels within acceptable limits	No deviations
Batch 002	Tablet B	Airflow control, dust extraction system	Dust levels slightly above threshold	Adjusted airflow settings

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
17/08/2025	Batch 003	Excessive dust during blending	Increased air extraction and reduced blending speed	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 Dust Control Methods	Enhanced Control Measures	QA Head