Standard Operating Procedure for Tablet Dedusting Monitoring in Compression Process

Department	Quality Control
SOP No.	SOP/TAB/129/2025
Supersedes	SOP/TAB/129/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for monitoring the tablet dedusting process during tablet compression to ensure that tablets are free from excess dust and particles, ensuring uniformity and product quality.

2. Scope

This SOP applies to the monitoring of the tablet dedusting process during the compression stage of tablet manufacturing to ensure that dust is effectively removed before further processing or packaging.

3. Responsibilities

• Quality Control (QC): Responsible for monitoring the tablet dedusting process, inspecting the tablets for dust, and ensuring compliance with cleanliness standards.
• Compression Operator: Responsible for ensuring that the tablet dedusting equipment is functioning properly and maintaining the required conditions for dedusting.
• Quality Assurance (QA): Ensures that the tablet dedusting process is performed according to this SOP and reviews the monitoring records for compliance.

4. Accountability

The QC Manager is accountable for ensuring that tablet dedusting is monitored accurately and consistently throughout the compression process. The QA Manager is responsible for reviewing and approving the monitoring results for compliance with regulatory standards.

5. Procedure

5.1 Tablet Dedusting Process

1. After the tablet compression process, tablets should pass through the dedusting system to remove any excess dust or particles from the tablet surface.
2. The dedusting process may involve mechanical or air-based systems such as tablet dedusting machines or vacuum systems.
3. Ensure that the dedusting machine is properly set up and calibrated to prevent any damage to the tablets and to ensure the removal of excessive dust.

5.2 Monitoring Dedusting Efficiency

1. Monitor the effectiveness of the dedusting process by inspecting a representative sample of tablets at regular intervals (e.g., every 100 tablets).
2. Check the tablets for visible dust or residue. If any tablet shows signs of dust or particles, note the issue and investigate potential causes, such as incorrect settings on the dedusting machine or improper air flow.
3. If dust is detected on any tablet, corrective actions must be taken immediately, including adjusting the machine settings or increasing the dedusting time.

5.3 Sampling and Inspection

1. Inspect tablets for dust accumulation and irregularities such as uneven dedusting or residue marks.
2. For each sample, record the number of tablets that meet cleanliness specifications (dust-free) and the number of tablets that require corrective action.
3. If more than 5% of the sample shows visible dust, increase the frequency of monitoring and investigate possible issues with the dedusting system.

5.4 Frequency of Monitoring

1. Tablet dedusting should be monitored continuously during the compression process, with checks performed on a representative sample every 15 minutes or after every 100 tablets produced.
2. If any deviation from the target dedusting efficiency is observed, increase the monitoring frequency until the issue is resolved.

5.5 Corrective Actions

1. If the dedusting process is found to be ineffective or the tablets are not sufficiently free of dust, corrective actions should be taken, including:
• Adjusting the settings on the dedusting equipment (e.g., air flow, machine speed, or tablet handling).
• Ensuring that the dedusting equipment is clean and functioning properly.
• Increasing the duration of the dedusting process if necessary.
2. After corrective actions, re-sample and test the tablets again for dust to confirm that the problem has been resolved.

5.6 Documentation

1. Record all tablet dedusting monitoring results, including the time of inspection, the number of acceptable tablets, and any corrective actions taken in the batch record (Annexure-2).
2. Document any deviations from the dedusting standards and corrective actions in the deviation report (Annexure-1).
3. Ensure that all records are signed, dated, and reviewed by QA to ensure compliance with quality standards.

5.7 Acceptance Criteria

1. The tablet surface must be free from visible dust or residue after the dedusting process. A maximum of 5% of the tablets in the sample may show minor dust, but this should not exceed the acceptable limit.
2. If the tablets fail the dedusting inspection, the batch may be rejected or reworked, and the dedusting process should be adjusted to meet the required standards.

5.8 Post-Compression Actions

1. Once the tablets are adequately dedusted, they can proceed to the next stages of manufacturing, such as coating or packaging.
2. Ensure that the dedusting equipment is cleaned and maintained regularly as part of the preventive maintenance schedule.

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-1)

8. References

• USP <905> – Content Uniformity and Tablet Coating
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Tablet Dedusting Specifications

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Visible dust found on 6% of tablets	Adjusted dedusting air flow	John Doe

Annexure-2: Batch Record

Sample Number	Dedusting Status	Action Taken
Sample 1	Dust-free	Accepted

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 dedusting monitoring criteria	Refined inspection and corrective actions	QA Head