Standard Operating Procedure (SOP) for Tablet Dedusting Process
Purpose
The purpose of this SOP is to establish guidelines for the tablet dedusting process in pharmaceutical manufacturing. It ensures the removal of dust and excess particles from tablets, resulting in improved appearance, reduced contamination risks, and enhanced product quality.
Scope
This SOP applies to all personnel involved in the tablet dedusting process within the pharmaceutical company.
Responsibilities
- The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP.
- The Production department is responsible for carrying out the tablet dedusting process.
Procedure
Preparation
- Inspect the tablets visually for any visible defects or foreign particles.
- Ensure that the tablet deduster is clean and in good working condition.
- Set up the dedusting machine according to the specifications provided for the particular tablet formulation.
- Verify that the deduster screens are clean and properly installed.
- Perform any necessary adjustments or calibrations on the deduster to ensure optimal performance.
Dedusting Process
- Start the tablet deduster and ensure that it is operating at the appropriate speed and vibration level.
- Feed the tablets into the dedusting machine in a controlled manner, following the recommended tablet feeding rate.
- Allow the tablets to pass through the deduster, where excess particles and dust are removed by the screens and air flow.
- Monitor the deduster operation to ensure
that tablets are effectively dedusted and excess particles are discharged properly.
Regularly check the screens for any clogging or buildup of material, and clean or replace them as necessary.
Collect the dedusted tablets in a clean and appropriately labeled container for further processing or packaging.
Post-Dedusting Verification
- Inspect the dedusted tablets for any visible defects, discoloration, or remaining particles.
- Conduct appropriate quality control tests on a representative sample of the dedusted tablets, as required by the product specifications.
- Record the results of the inspection and quality control tests accurately.
- If any issues or deviations are identified, immediately report them to the appropriate department for investigation and corrective action.
Abbreviations
- QA: Quality Assurance
- SOP: Standard Operating Procedure
Documents
- Tablet Dedusting Log
References
No specific references are applicable for this SOP.
SOP Version
This is version 1.0 of the SOP for Tablet Dedusting Process.
