Standard Operating Procedure for Tablet Dedusting Process
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/039/2025 |
| Supersedes | SOP/TAB/039/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 22/08/2025 |
| Effective Date | 27/08/2025 |
| Review Date | 22/08/2026 |
1. Purpose
This SOP defines the procedure for the tablet dedusting process, which ensures that the tablets are free from loose powder or dust particles that may interfere with tablet appearance, quality, and subsequent packaging.
2. Scope
This SOP applies to all tablet formulations that require dedusting as part of the post-compression process. It includes procedures for effectively removing dust from tablets to maintain product integrity and quality.
3. Responsibilities
- Manufacturing Personnel: Responsible for ensuring that tablets are properly dedusted before packaging and that the dedusting equipment is correctly set up and maintained.
- Quality Control (QC): Responsible for verifying that the tablets meet the required cleanliness standards after dedusting and that no dust or residue is present on the tablets.
- Quality Assurance (QA): Ensures that the dedusting process is conducted in accordance with this SOP and that the cleanliness of tablets is monitored and documented.
4. Accountability
The Production Manager is accountable for ensuring the proper execution of the tablet dedusting process. The QA Manager is responsible for verifying that the dedusting process meets the required quality standards and for ensuring that proper documentation is maintained.
5. Procedure
5.1 Pre-Dedusting Setup
- Ensure that the tablets are fully compressed and ready for dedusting.
- Verify that the dedusting equipment, such as the dedusting machine or air blower, is clean and functioning properly. Ensure that it is calibrated and set to the correct speed and pressure levels as per the specifications for the formulation.
- Check the environmental conditions, such as room temperature and humidity, to ensure that they are suitable for the dedusting process.
- Ensure that all operators wear the required protective equipment (e.g., gloves, masks) to maintain hygiene during the process.
5.2 Dedusting Process
- Place the tablets into the dedusting machine, ensuring that the tablets are evenly distributed to avoid damaging the tablets during the dedusting process.
- Set the dedusting machine to the appropriate settings for the tablet size and type, ensuring the machine uses the correct airflow and brush settings to remove excess dust without damaging the tablets.
- Operate the dedusting machine to remove loose dust or powder from the tablet surface. The machine should utilize a combination of airflow and brushing to dislodge particles effectively.
- Monitor the process to ensure that all tablets are adequately dedusted, paying attention to the uniformity of dedusting to avoid uneven powder accumulation.
- If the tablets are not adequately cleaned, adjust the settings on the machine and repeat the dedusting process as necessary.
5.3 Post-Dedusting Inspection
- After the dedusting process, visually inspect the tablets for any remaining dust or particles. Tablets should have a clean surface without any loose powder or visible residue.
- Perform a random sample check by picking several tablets from the batch and inspecting them for cleanliness under appropriate lighting.
- Ensure that the tablets pass the cleanliness standards as outlined in the product specification sheet and the quality control testing criteria.
- If any tablets fail the cleanliness check, remove them from the batch and reprocess them by repeating the dedusting procedure.
5.4 Documentation and Record-Keeping
- Document all details of the dedusting process, including batch number, tablet type, dedusting settings, and any deviations or adjustments made during the process in the batch record (Annexure-1).
- Record any failure to meet the cleanliness standards in the deviation report (Annexure-2) and document any corrective actions taken.
- Store the batch records and inspection results for future reference, audits, and quality reviews.
5.5 Equipment Cleaning and Maintenance
- After each dedusting process, clean the dedusting machine to remove any residual dust or powder. Follow the equipment cleaning SOP to ensure proper maintenance of the machine.
- Inspect the dedusting machine regularly for any wear or damage to the brushes, air nozzles, or other components. Replace any parts that are worn or damaged to maintain optimal functionality.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Batch Record (Annexure-1)
- 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 | Dedusting Settings | Tablet Cleanliness | Remarks |
|---|---|---|---|---|
| Batch 001 | Tablet A | Speed: 10, Pressure: 2.5 bar | Pass | Uniform dust removal |
| Batch 002 | Tablet B | Speed: 12, Pressure: 3.0 bar | Pass | Minor adjustment to speed |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 23/07/2025 | Batch 003 | Uneven dust removal | Adjusted dedusting machine 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 Dedusting Parameters | Optimized Process | QA Head |