Standard Operating Procedure (SOP) for Cleaning and Maintenance of Tablet Deduster
Purpose
The purpose of this SOP is to provide guidelines for the effective cleaning and maintenance of the tablet deduster in pharmaceutical manufacturing. It ensures the optimal performance of the equipment, minimizes the risk of cross-contamination, and maintains product quality and compliance with regulatory requirements.
Scope
This SOP applies to all personnel involved in the cleaning and maintenance 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 cleaning and maintenance tasks.
Procedure
Cleaning
- Switch off the tablet deduster and disconnect the power supply before starting the cleaning process.
- Wear appropriate personal protective equipment (PPE) such as gloves and safety glasses.
- Remove any remaining tablets from the deduster, ensuring they are properly disposed of or transferred to the appropriate container.
- Disassemble the deduster components, such as screens, discharge chute, and covers, as applicable.
- Thoroughly clean each component using a mild detergent solution and a soft brush.
- Rinse all the components with clean water to remove any detergent residue.
- Dry the components completely using lint-free cloths or by air drying.
- Inspect the screens for any damages or clogging and clean or replace them as necessary.
- Reassemble the deduster, ensuring that all components are properly aligned and securely fixed.
Maintenance
- Regularly inspect the deduster for signs of wear, malfunction, or damage.
- Tighten any loose bolts, screws, or fasteners to ensure stability and proper functioning.
- Check the electrical connections and cords for any fraying or damage.
- Verify that the vibration settings of the deduster are calibrated and functioning correctly.
- Lubricate the moving parts of the deduster, if applicable, according to the manufacturer’s recommendations.
- Perform routine calibration checks on the deduster to ensure accuracy.
- Maintain accurate and up-to-date maintenance records for the tablet deduster.
Abbreviations
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- SOP: Standard Operating Procedure
Documents
- Tablet Deduster Cleaning Log
- Tablet Deduster Maintenance Log
References
No specific references are applicable for this SOP.
SOP Version
This is version 1.0 of the SOP for Cleaning and Maintenance of Tablet Deduster.