OBJECTIVE
To lay down a procedure for the operation of the vibro sifter.
SCOPE
This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities of XYZ Limited.
RESPONSIBILITY
The concerned operator is responsible for the implementation of the process.
The Production In-Charge is responsible for the execution and compliance of the procedure.
PROCEDURE
Pre Checks
- Availability of trained operating personnel wearing clean uniforms, gloves, and nose masks.
- Availability of power supply.
- Availability of dispensed raw material.
- Availability of clean SS container to collect sieved material.
- Ensure the cleanliness of the area and machine.
Machine Assembling
- Place a gasket over the main body, place the bottom drum assembly, and clamp it.
- Check and place the sieve of the required mesh size as per product requirement over the bottom assembly and then place the top drum assembly and clamp it.
- Finally, place the top cover at the top assembly and tight with the clamp.
Operation
- Label the sifter and check for line clearance.
- Put ON the switch and start the Sifter.
- Check for the abnormal noise, if yes then switch OFF the machine and rectify it by tightening the clamps.
- Place the SS container lined with a polyethylene bag below the discharge chute and retention chute.
- Affix the proper label on the container.
- Put sifter On, and proceed for continued operation.
- Charge the material that is to be sifted on the top assembly through the inlet and collect the sifted material through the discharge chute and retention chute into the respective containers.
- After finishing the operation put OFF the mains.
- Follow the BMR instructions for sieve size and sequence of material sifting.
- Note: The integrity of the sieve must be checked before the completion of the sifting activity against the light.
- All the operation details shall be entered in the equipment usage log.
REFERENCE
SOP: Preparation, Approval, and Control of Standard Cleaning Procedures for equipment.
ABBREVIATION
Q.A: Quality Assurance
SOP: Standard Operating Procedure
No.: Number
P.D: Production
ANNEXURE
Nil.
REVISION HISTORY
Nil.
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