SOP FOR OPERATION AND CLEANING OF OSCILLATING GRANULATOR
OBJECTIVE: To lay down the procedure for operation and cleaning of Oscillating Granulator.
SCOPE: This procedure is applicable for operation and cleaning of Oscillating Granulator.
RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP during use of Oscillating Granulator.
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.
ACCOUNTABILITY:
Head of the Production Department.
PROCEDURE:
Pre-startup (In the beginning of sifting):
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 screen of the Oscillating Granulator. If it is damaged, change it with intact one.
Operation:
Before start the operation production officer get the line clearance from QA person and affix the status label with product name. Batch detail to equipment and area.
Fix the assembly reverse and forward .
Fit the screen of required size and the hopper properly.
Set the Oscillating Granulator in required direction by moving the knob. Then adjust the required speed.
Tie the poly bags to the discharge Hopper of Oscillating Granulator by cable tie and keep the poly bags in stainless steel. In process container and then place container below the discharge port.
Put ON the mains, then press green button and load the material, adjust the Hopper so that material will feed slowly and checks for smooth functioning of the machine.
Control the flow with stopper plate and ensure that the hopper is not charged heavily otherwise the Oscillating Granulator can get blocked.
Put OFF the mains after completion of the operation.
Record equipment usage in usage log book.
Cleaning:
Cleaning at the time of batch changeover/same product of ascending potency.(TypeA Cleaning)
Remove all the left over powder particles on the machine using vacuum cleaner and lint free mop.
Dismantle following and take those to washing area:
Hopper
Oscillating chamber
Powder Tray
Clean the powder tray, hopper, oscillating chamber and machine body by vacuum cleaner and wiping with using dry lint free mop.
After cleaning affix the “CLEANED” status label on the equipment.
Record the cleaning details in the usage log book.
Cleaning at the time of product changeover/same product of descending potency/after preventive maintenance of the contact parts. ( Type B Cleaning)
Dismantle following and take those to washing area:
Hopper
Oscillating chamber
Powder Tray
Remove all the left over powder particles on the machine using vacuum cleaner and lint free mop.
Clean the Oscillating Granulator and all Dismantle parts with help of purified water.
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 traces.
Sanitize the all parts with 70% IPA solution and assemble
Affix “CLEANED” status label.
Record the cleaning details in activity log book.