Standard Operating Procedure (SOP) for Deduster Screen Replacement and Calibration
Purpose
The purpose of this SOP is to provide guidelines for the proper replacement and calibration of screens used in the tablet deduster. It ensures accurate particle separation, effective dedusting, and maintains the quality and integrity of the tablets during the manufacturing process.
Scope
This SOP applies to all personnel involved in the screen replacement and calibration of the tablet deduster within the pharmaceutical company.
Responsibilities
- The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP.
- The Production department is responsible for performing the screen replacement and calibration.
Procedure
Screen Replacement
- Inspect the existing screens for any signs of damage, wear, or clogging that may affect their performance.
- If damaged or clogged, mark the screens for replacement.
- Obtain clean and properly labeled replacement screens from the designated storage area.
- Carefully remove the old screens from the deduster, ensuring not to damage any other components.
- Install the new screens into the deduster, following the manufacturer’s instructions and ensuring proper alignment.
- Securely fasten the screens, ensuring that they are tightly fitted to prevent any shifting or movement during operation.
Screen Calibration
- Select a representative sample of tablets with known sizes and characteristics for calibration.
- Place the calibration sample into the deduster and run the dedusting
process as per standard operating conditions.
Collect the dedusted tablets and visually inspect them for any defects or remaining particles.
Perform a particle size analysis using appropriate analytical methods and equipment.
Compare the particle size distribution of the dedusted tablets with the known characteristics of the calibration sample.
Adjust the deduster settings, if necessary, to optimize the dedusting process and ensure the desired particle size distribution.
Maintain accurate calibration records, including the calibration date, sample used, and results obtained.
Abbreviations
- QA: Quality Assurance
- SOP: Standard Operating Procedure
Documents
- Deduster Screen Replacement Log
- Deduster Screen Calibration Log
References
No specific references are applicable for this SOP.
SOP Version
This is version 1.0 of the SOP for Deduster Screen Replacement and Calibration.
