SOP FOR OPERATION AND CLEANING OF SCREW CAPPING MACHINE
OBJECTIVE: To lay down the procedure for operation and cleaning of Screw capping machine.
SCOPE: This procedure is applicable for operation and cleaning of Screw capping machine.
RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP during capping of filled bottles.
Officer Production/Supervisor or designee is responsible for execution of SOP and maintaining the records.
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 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 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
Operation procedure:
Replace “cleaned” label with “Under process” label.
Get the line clearance from In Process Quality Assurance (IPQA) person
For Manual mode press manual button.
Load the required Screw caps into the hopper. Put the main motor “ON”.
Press ON button to On the Conveyor motor and Operational motor.
Ensure the Capping is proper of all the six heads initially and every half hour thereafter.
Ensure that skirting is proper and after quarter round the cap starts breaking the bridges.
Also ensure that while opening the cap for the first time the bridges are cut easily and the ring is easily separated.
Ensure that once opened cap when refitted, bottle does not leak.
Ensure that the vibrator is working properly and screw caps are freely flowing through the chute/feeder to the Capping heads when filled bottles are coming for Capping.
Ensure that when there is no bottle, no cap is discharged through the chute.
After completion of the batch/end of days 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.
Cleaning procedure:
Type-A Cleaning procedure:
Remove the “TO BE CLEANED” Label from the equipment. Tear the label after checking the details on it.
Put “OFF” the electric supply.
Remove and discard the left over quantity of Screw Caps from the hopper and chute and record in BMR.
Clean all parts using wet lint free mop followed by dry lint free mop.
Affix “CLEANED” status label and record the cleaning details in usage log book.
Frequency: – Clean the machine before start of the activity, after each & every break down and at the end of shift.
Type-B Cleaning procedure:
During product to product change of the different product or drug strength decrease, Type-B cleaning shall be performed.
Switch “OFF” the mains of machine.
Remove and discard the left over quantity of Screw Caps from the hopper and chute and record in BMR.
Clean the machine accessories using lint free mop dipped in purified water followed by dry lint free mop.
IPA 70% mopping shall be done by a lint free cloth.
Ensure that all the parts are clean and dry.
Affix “CLEANED” status label and record the cleaning details in activity log book.
Frequency: – Clean the machine during product to product change of the different product or drug strength decrease & every major maintenance break down and at the end of shift.