SOP Guide for Pharma

Tablets: SOP for Tablet Dedusting Monitoring in Compression Process – V 2.0

Auditor

Tablets: SOP for Tablet Dedusting Monitoring in Compression Process – V 2.0

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

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.
See also  Tablets: SOP for Layer Thickness Monitoring in Multi-Layer Tablets - V 2.0

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.
See also  Tablets: SOP for Intermediate Precision Testing for Tablets - V 2.0

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.
See also  Tablets: SOP for Adhesion Monitoring in Sugar-Coated Tablets - V 2.0

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

7. Documents

  1. Batch Record (Annexure-2)
  2. Deviation Report (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: 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
Exit mobile version