1.1 To describe the procedure for operation of Vibratory Sifter.
- Technical Assistant – To follow the SOP & operation of sifter.
- Executive – To verify the operation of sifter
- Executive – Responsible for compliance of SOP.
Vibratory Sifter is used in Sifting of materials in Pharmaceutical manufacturing with different mesh of Sieves and it is widely used equipment in pharmaceuticals and in food industries.
Uses of Vibratory Sifter :
Sifting is done to remove lumps or growth that might have formed on the materials after being stored for a longer period and materials are passed through a mesh that opens, which leads to fine the materials.
It also removes the unrequired foreign particles and separate the materials according to size
For working principle of sifter Pl. Refer https://pharmaceuticalupdates.com/2020/04/28/working-and-principle-of-vibratory-sifter/
- Check the area and machine for cleanliness.
- Take line clearance from QA, before starting the operation.
- Remove the “CLEANED” label and affix the “UNDER PROCESS” label to the sifter.
- Procure all the materials of required quantity as per the BPRR to be sifted in the sifting area.
NOTE: Sift the materials using specified sieves as mentioned in the Batch record of that product.
- SET- UP
FIXING OF THE SIEVE:
- Check the sieve size for correctness as mentioned in the Batch manufacturing record
- Check the Sieve integrity before fixing to the sifter.
- Place the sieve over lower hopper and place upper hopper over it and clamp them with the clamp provided.
FIXING OF LID
- Place the lid above the upper Hopper.
- Align the lid from all the sides with respect to hopper.
- Put the power plug into the power supply socket.
- Switch on/off the mains and ensure that it is working properly and ensure the proper earthing to the sifter or static electricity clamp can be used to avoid static charges.
- Place SS container/In process Container below the product outlet and the retention chute.
- Tie one end of the lint free cloth or Silicon bellow to the open end of the discharge chute of the sifter and other end to the container placed below the discharge chute.
- Place the raw material to be sifted in the IPC and lift the IPC with the help of Material handling device and connect the discharge chute of the IPC to the top of the sifter with dust free interface.
- Adjust the In process Container (IPC) such that the cone is just inside the charging port provided to the sifter lid.
- Tie or place silicon bellow to the lid of the sifter and ensure it is aligned properly with discharge of the IPC.
- Switch on the sifter and open the butterfly valve of the IPC to regulate the flow of the material to be sifted.
NOTE: In case of unavailability of IPC the raw materials can be kept in SS containers and sifting should be done manually only.
- After completion of sifting of the material, switch off the sifter and bring down the IPC check for any material remaining in the IPC, if there is any remaining material follow the above step and continue sifting.
- During sifting retains are collected in double lined polythene bags / IPC through the discharge chute of the sifter on the upper hopper by opening the discharge clamp.
- Repeat the above procedure for remaining material. After completion of the batch Switch off the mains.
- Dismantle the sieve and check its integrity and enter the details in the BPRR.
- Update the status label as “TO BE CLEANED”.
- Record the operation of the machine in the equipment log book.
5.1 IPC – In process Container.
5.2 BPRR – Batch Processing Record
5.3 Q.A. – Quality Assurance
5.4 SS – Stainless Steel
This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing department.
9.0 SOP Revision History record
|Revision No.||Details for Revision(s) with Change Control No.||Effective Date (Sign. / Date)|