Standard Operating Procedure (SOP) for Operation of Sieving Machine
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the safe and efficient operation of the sieving machine in order to maintain the quality and integrity of pharmaceutical products.
2. Scope
This SOP applies to all personnel involved in operating the sieving machine within the pharmaceutical company.
3. Responsibilities
- The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP.
- The Production department is responsible for operating the sieving machine.
4. Procedure
The following steps outline the procedure for the operation of the sieving machine:
4.1. Pre-Operation
- Inspect the sieving machine 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 machine is clean and free from any residue or foreign particles.
- Check that the sieves are clean, in good condition, and properly installed in the machine.
4.2. Operation
- Switch on the power supply and ensure that the machine is properly connected.
- Set the desired sieving parameters (such as vibration intensity and duration) according to the product specifications.
- Ensure that the material to be sieved is prepared and placed in the feed hopper of the machine.
- Start the sieving process by
activating the machine.
Monitor the sieving operation to ensure smooth and consistent flow of material through the sieves.
Inspect the sieved material 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 sieving process is complete, switch off the machine and disconnect the power supply.
Clean the sieving machine thoroughly, including the sieves, to remove any residual material.
Properly store the sieving machine in its designated location.
5. Abbreviations Used
- QA: Quality Assurance
- SOP: Standard Operating Procedure
6. Documents
- Sieving Machine Maintenance Log
7. References
No specific references are applicable for this SOP.
8. SOP Version
This is version 1.0 of the SOP for Operation of Sieving Machine.