Standard Operating Procedure (SOP) for Operation of Tablet Deduster
Purpose
The purpose of this SOP is to provide guidelines for the safe and efficient operation of the tablet deduster in pharmaceutical manufacturing. It ensures the removal of dust and excess particles from tablets, maintaining product quality and compliance with regulatory standards.
Scope
This SOP applies to all personnel involved in the operation 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 the operation of the tablet deduster.
Procedure
Pre-Operation
- Inspect the tablet deduster for any visible damage or malfunction.
- Ensure that all safety guards are in place and properly secured.
- Check the electrical connections and ensure they are properly grounded.
- Verify that the dedusting chamber is clean and free from any residual material.
- Check that the tablet feed mechanism is functioning properly.
Operation
- Switch on the power supply and ensure that the deduster is properly connected.
- Set the desired dedusting parameters, such as vibration intensity and air flow, according to the product specifications.
- Ensure that tablets are properly prepared and fed into the dedusting chamber.
- Start the dedusting process by activating the machine.
- Monitor the operation to ensure the tablets are being effectively dedusted and excess particles are removed.
- Inspect the dedusted tablets for any abnormalities or deviations from the required specifications.
- If any issues or deviations are observed, immediately stop the machine and report them to the appropriate department for further investigation.
- Once the dedusting process is complete, switch off the machine and disconnect the power supply.
- Clean the deduster thoroughly, including the dedusting chamber, screens, and discharge chute, to remove any residual dust or tablet fragments.
Abbreviations
- QA: Quality Assurance
- SOP: Standard Operating Procedure
Documents
- Tablet Deduster Cleaning Log
References
No specific references are applicable for this SOP.
SOP Version
This is version 1.0 of the SOP for Operation of Tablet Deduster.