SOP FOR OPERATION AND CLEANING OF MEASURING CUP PLACING MACHINE
OBJECTIVE: To lay down the procedure for operation and cleaning of Measuring Cup Placing Machine.
SCOPE: This procedure is applicable for operation and cleaning of Measuring Cup Placing Machine.
RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP during sealing of dry syrup.
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:
Replace “cleaned” label with “Under process” label.
Get the line clearance from In Process Quality Assurance (IPQA) person.
Load the required Plastic Screw Caps into the hopper.
Put “ON” the vibrator.
Set the height of the machine in such a way that measuring cap discharge chute is 1 cm above the cap of sealed bottle.
Put ‘ON’ the green button of machine to START.
Put the sensors in their respective position i.e. bottle incoming/outgoing sensors and counter sensor at their respective positions.
Ensure that sensors are functioning.
Send the filled and sealed HDPE/Glass bottles on the machine belt.
Ensure that the screw caps are having Wad seal inside.
Run the conveyor belt.
Ensure that the counter is also working.
Run the machine continuously.
Record the findings in the respective BPR.
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 Usage log book.
Cleaning:
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 before starting the cleaning by turn OFF button and then by operating the main switch of respective turntable.
Remove and discard the left over quantity of measuring caps from the hopper and chute and record in BPR.
Clean the measuring caps, machine railing guide using dry lint free mop.
Clean the sensors using dry mop only.
Affix “CLEANED” status label and record the cleaning details in usage log book.
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 measuring caps from the hopper and chute and record in BPR
Clean the measuring caps using lint free mop dipped in purified water followed by dry lint free mop.
Also ensure that no wet mop or water comes in contact with the sensors.
If required, wipe out sensors very carefully using moist but almost dry lint free mop taking care that no supply or critical part comes in contact with water.
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.
Record the cleaning details in the usage log book.
Frequency: – Clean the turntable before start of the activity, after each & every break down and at the end of shift.