SOP FOR OPERATION AND CLEANING DRY SYRUP FILLING MACHINE
OBJECTIVE: To lay down the procedure for operation and cleaning of dry syrup filling machine.
SCOPE: This procedure is applicable for operation and cleaning of dry syrup filling machine
RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP during dry syrup filling machine.
Officer Production/Supervisor or designee is responsible for execution of SOP and maintaining the records.
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-start up:
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 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.
Operation:
Replace “cleaned” label with “Under process” label.
Get the line clearance from In Process Quality Assurance (IPQA) person.
Bring in all the blend of the particular batch.
To get proper constant flow of the blend into the hopper at manually.
Do de-cartoning of plastic bottles and load on turn table for inspection.
Inspected and air jet cleaned vials will move in filling room turn table.
Ensure sufficient quantity visually inspected bottles are supplied to the filling machine.
Fill hopper with blend in manually.
Adjust all the filling cups to the required weight as described in BMR.
Check the weight of all twelve heads and if required, adjust the same to the required range as per BMR using weight adjustment screws.
Lock all the wt. adjustment screws by putting S.S. Clips.
Switch “ON” the main of machine, Dust extractor,
Check the weight of initial twelve bottles and confirm that those are in the permitted range. Continue checking there after every half an hour.
Record the weights in the corresponding BMR.
Once the weight correctness is confirmed, run the machine continuously at optimum speed.
Do not allow to fluctuation the level of the powder in the hopper.
When filling comes to an end, observe the weights critically.
When the weight is found to be out of limit, stop the machine and remove the left-over quantity of blend. Record the weight in BMR and discard as per procedure.
Switch “OFF” the main of filling machine dust extractor.
Switch “OFF” the main electrical supply.
Affix duly filled “TO BE CLEANED” Label on the equipment.
Record the equipment uses details in activity log book.
Note: Ensure activity of powder dropping in bottle and before sealing of bottle is carried out under continuous purging of Nitrogen.
Cleaning
Cleaning at the time of batch changeover/same product of ascending potency(Type-A):
Switch “OFF” main electric supply to the machine.
Remove all the left over powder particles on the machine using vacuum cleaner and lint free mop
Remove the left over empty bottles from turn table and filling machine platform, destroy and record in BMR.
Open the dust collection box of dust extractor unit, collect and weight the powder, destroy and record in BMR.
Open the vacuum pot and remove the filter bag and clean dry in wash room and refit in to vacuum pot.
Clean all machine in filling room with vacuum cleaner and lint free mop.
Remove doctor blade and open the rotary wheel. Clean them properly with lint free mop and refit same as earlier.
Clean all the parts using wet lint free mop followed by dry lint free mop.
Ensure that all the parts are clean and dry.
After cleaning affix the “CLEANED” label on the equipment.
Record the cleaning details in the activity log book.
Cleaning at the time of product changeover/same product of descending potency/preventive maintenance of the contact parts(Type-B):
Switch “OFF” main electric supply to the machine.
Remove all the left over powder particles on the machine using vacuum cleaner and lint free mop.
Remove the left over empty bottles from turn table and filling machine platform, destroy and record in BMR.
Open the dust collection box of dust extractor unit, collect and weight the powder, destroy and record in BMR.
Open the vacuum pot and remove the filter bag and clean in wash room.
Wash filter bag with hot purified water and keep to dry. Dismantle the pot and wash with hot purified water in washing room.
After drying the bag fit into vacuum pot.
Remove doctor blade and open the rotary wheel and hopper. Dismantle the pistons and filter tips from rotary wheel and clean them properly with purified water
Washed all parts with purified water and dry with compressed air and lint free mop.
Clean all the parts using wet lint free mop followed by dry lint free mop.
Ensure that all the parts are clean and dry.
Rinse the dismantled parts with purified water and intimate to IPQA to collect the rinse water sample.
IPQA will send the Swab/ rinse water sample to Q.C. department as per procedure define in their respective SOP,SOP titled with “SOP of collection of Swab & Rinse Sample” to confirm the absence of previous product
Sanitize all parts with 70% IPA and assemble.
After cleaning affix the “CLEANED” label on the equipment.
Record the cleaning details in the usage log book.