SOP FOR OPERATION AND CLEANING OF VIBRO SIFTER
OBJECTIVE: To lay down the procedure for operation and cleaning of Vibro Sifter.
SCOPE: This procedure is applicable for operation and cleaning of Vibro Sifter.
RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP during sifting of materials.
Officer/Supervisor or designee of IPQA is responsible for the line clearance and verification of the related documents along with ensuring the compliance of SOP.
Technician/Officer or designee of engineering department is responsible for the maintenance/repair work of the machine if any break down occurs during the operation.
Manager/Executive or designee of Production department is responsible for giving the training on regarding tasks and review the related records.
QA responsible for verification of completion of product to the procedure.
ACCOUNTABILITY: Head of the Production Department.
PROCEDURE:
Pre-startup (In the beginning of shifting):
Ensure that no remnants of previous product/batch are present.
Visually check the equipment and area for its cleanliness.
Ensure “cleaned” label status on the equipment.
Check the cleanliness of the room.
Check the material kept in the room and ensures that it is of the same batch to proceed.
Check the room temperature and relative humidity and record it in BMR. If it is not within the limit inform the maintenance department and do not proceed till it gets rectified.
Check the integrity of the sieve of the Vibro sifter. If it is damaged, change it with intact one.
Operation:
Replace “cleaned” label with “Under process” label.
Check and ensure the cleanliness and integrity of the sieves. Ensure that they are properly fixed to the equipment as per the product specification.
Fix SS Sieve to the sifter as defined in BMR with help of SS ring with clamp and gasket.
Check and ensure the cleanliness of scoops used for pouring the material.
Get the line clearance from In Process Quality Assurance (IPQA) person.
Transfer the raw material to be sifted near the equipment.
Transfer the poly bag lined cleaned container near to the sifter and tie poly bag with help of cable tie to the discharge chute of the sifter.
Connect the plug of the equipment to the main power supply.
Switch “ON” the main power supply and run the machine till complete shifting the product. After completion of operation switch “OFF” the machine.
Replace “Under process” label with “To be cleaned” label.
Label the container and tighten the bag with cable tie band.
Close container and placed on separate trolley and send for further processing.
Record equipment usage in usage logbook.
Cleaning:
Cleaning at the time of batch changeover/same product of ascending potency (Type-A):
Remove loosely stacked powder from the machine by using vacuum cleaner and lint free mop.
Dismantle the machine in the following sequence and keep them on pallet:
- Upper lid.
- SS ring with clamps
- Gasket
- Sieves
- Upper feeding hopper
- Clean the dismantled parts by using vacuum cleaner and lint free mop.
- Clean the machine with a dry lint free mop.
- Clean the room thoroughly.
- Assemble the cleaned dismantled parts.
After cleaning affix, the “CLEANED” status label on the equipment.
Record the cleaning details in the activity logbook.
Cleaning at the time of product changeover/same product of descending potency/preventive maintenance of the contact parts (Type-B):
Remove loosely stacked powder from the machine by using vacuum cleaner and lint free mop.
Dismantle the machine in the following sequence and keep them on pallet:
- Upper lid
- SS ring with clamps
- Gasket
- Sieves
- Upper feeding hopper
- Lower feeding hopper
- Clean all the parts with purified water.
- Finally wash with purified water thoroughly.
- Dry the parts using lint free mop.
Clean the machine with a wet lint free mop followed by dry lint free mop.
Clean the room thoroughly.
Rinse the dismantled parts with purified water and intimate to IPQA to collect the rinse water sample.
IPQA will send the rinse water sample to Q.C. department to confirm the absence of previous product.
Sanitize the all parts with 70% IPA solution and assemble.
Affix “CLEANED” status label and record the cleaning details in usage logbook.
Record the cleaning details in the equipment usage logbook.