Standard Operating Procedure for Anti-Dusting Measures in Tablet Compression

Department	Tablet
SOP No.	SOP/TAB/029/2025
Supersedes	SOP/TAB/029/2022
Page No.	Page 1 of 6
Issue Date	03/07/2025
Effective Date	08/07/2025
Review Date	03/07/2026

1. Purpose

This SOP defines the procedures for implementing anti-dusting measures during tablet compression to ensure a safe and clean environment. Reducing dust in the compression process is critical to improving tablet quality, protecting the operators, and maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to the tablet compression process and covers the equipment, operational procedures, and safety measures to minimize dust generation. It includes both preventive and corrective measures to control dust levels during tablet production.

3. Responsibilities

• Manufacturing Personnel: Responsible for adhering to anti-dusting procedures during the tablet compression process and ensuring all equipment is used correctly to minimize dust exposure.
• Health and Safety Officer: Ensures that appropriate protective equipment (PPE) is available and used, and that environmental dust levels are monitored for compliance with safety standards.
• Quality Control (QC): Responsible for verifying that dust levels are within acceptable limits and that any deviations are documented and addressed promptly.
• Maintenance Personnel: Ensures that dust control systems, such as air filtration and vacuum systems, are regularly maintained and functioning properly.

4. Accountability

The Production Manager is accountable for ensuring that anti-dusting measures are in place and that the tablet compression process is performed in compliance with this SOP. The Health and Safety Officer is responsible for maintaining safety standards related to dust control.

5. Procedure

5.1 Pre-Compression Setup

1. Ensure that all compression equipment is properly set up and calibrated to reduce dust generation during the compression cycle.
2. Check that dust collection systems, such as vacuum units or air filtration systems, are operational and set to the required suction power.
3. Verify that tablet press enclosures, dust covers, and containment hoods are in place to capture and contain dust generated during the compression process.
4. Ensure that operators are wearing the appropriate personal protective equipment (PPE), including masks, gloves, and protective eyewear, to prevent exposure to dust.

5.2 Dust Prevention During Compression

1. Operate the tablet press with the correct settings to minimize the generation of powder dust. Adjust parameters such as compression speed and die-fill level as needed.
2. Ensure that any granulation or powder used for compression is properly pre-screened to remove larger particles that could generate dust during compression.
3. Regularly monitor the dust levels around the tablet press. If dust levels exceed acceptable limits, stop the process immediately to assess and rectify the issue.
4. Ensure that any excess powder or granules are immediately cleaned up from the surrounding areas to prevent dust accumulation. Use a vacuum system rather than blowing air to remove powder to avoid resuspending dust in the air.

5.3 Use of Dust Control Equipment

1. Ensure that dust control equipment, such as localized exhaust hoods, vacuums, and air filtration units, are operational at all times during tablet compression.
2. Check that dust extraction points are positioned effectively near tablet presses to capture airborne dust. The extraction rate should be sufficient to maintain air quality in the working environment.
3. Regularly inspect the dust control equipment to ensure that filters are clean and that suction power is sufficient to remove dust from the area. Replace filters as needed based on manufacturer guidelines.
4. If dust control equipment fails or malfunctions, stop the compression process immediately and report the issue to the Maintenance Department for immediate repair.

5.4 Monitoring and Control of Air Quality

1. Regularly monitor the air quality in the tablet compression area to ensure that dust levels are within the acceptable range. Use air monitoring devices to measure dust concentration in the working environment.
2. Ensure that the tablet compression area is ventilated properly. Use air filtration systems to keep the air clean and remove any airborne particulates.
3. If dust levels exceed the acceptable limits, increase the suction power of the dust collection system, reduce the tablet press speed, or implement additional dust containment measures until the levels return to normal.

5.5 Cleaning and Maintenance

1. After each tablet compression cycle, clean all equipment, including tablet presses, dust collection systems, and surrounding areas, to remove any accumulated powder or granules.
2. Follow the equipment cleaning SOP to ensure that all surfaces are free from dust and granules, and that no cross-contamination occurs between batches.
3. Perform regular maintenance checks on dust control systems, including vacuum units, air filtration systems, and exhaust hoods, to ensure that they are operating effectively. Log all maintenance activities in the equipment maintenance log (Annexure-1).
4. Inspect the filters in the dust collection system periodically and replace them when necessary to maintain optimal dust control performance.

5.6 Documentation and Record-Keeping

1. Document all dust control procedures, including pre-setup checks, monitoring data, and corrective actions taken, in the batch record (Annexure-2).
2. Record any issues related to dust control, such as excessive dust levels, equipment malfunctions, or corrective actions, in the dust control log (Annexure-3).
3. Ensure that all inspection and cleaning activities related to dust control are recorded and signed off by the responsible personnel, and that records are stored for future reference and audits.

5.7 Post-Compression Procedure

1. After the compression process is complete, inspect the working area for any residual dust and clean as necessary using a vacuum system.
2. Ensure that the tablet press is covered or enclosed to prevent dust exposure to the surrounding environment during the equipment idle time.
3. Perform a final inspection of the compression area to ensure that dust levels are within acceptable limits and that all dust containment systems are functioning properly.

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. Dust Control Log (Annexure-3)
3. Equipment 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: Equipment Maintenance Log

Maintenance Date	Equipment	Maintenance Type	Performed By	Remarks
01/06/2025	Compression Machine	Routine Maintenance	John Doe	Checked dust control systems
15/06/2025	Compression Machine	Filter Replacement	Jane Smith	Replaced vacuum system filters

Annexure-2: Batch Record

Batch Number	Tablet Type	Dust Control System Status	Action Taken	Remarks
Batch 001	Tablet A	Functional	Dust levels monitored	Within specifications
Batch 002	Tablet B	Operational	Adjusted suction power	Monitored throughout process

Annexure-3: Dust Control Log

Date	Equipment	Dust Level	Corrective Action	Remarks
02/06/2025	Tablet Press	High	Increased suction power	Dust levels reduced
12/06/2025	Tablet Press	Normal	No action needed	Process stable

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 Monitoring System	Enhanced Dust Control Measures	QA Head