SOP FOR OPERATION AND CLEANING OF INDUCTION SEALING MACHINE
OBJECTIVE: To lay down the procedure for operation and cleaning of Induction sealing machine.
SCOPE: This procedure is applicable for operation and cleaning of Induction Cap Sealing 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:
Definition:
Induction Sealing: The purpose of the induction cap/ induction sealing sealer is to provide tamper evidence, prevent the ingress of moisture and oxygen, and avoid leakages. Proper sealing can be achieved by selecting caps, induction wads & containers having proper fit &
Process Description/Process Principle:
Post filling an induction seal is inserted in to the cap either manually or by a wad fitting equipment.
The container is filled and capped in a standard operation and then passed beneath the sealing coil through a conveyor.
After removing the cap foils will remain bounded to the lip of container
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.
Gap Setting: Adjust guide to get proper curvature of film. The gap between the electrode and roller should not exceed more than 3 mm and should be uniform. The minimum gap should not be less than 1 mm. Avoid touching the electrode to the sleeves. Adjust the treatment keys to the exact width of film or 3 mm less than the film width.
Put ‘ON’ the green button of machine to START.
Set the optimum value of sealing Ampere at which induction sealing is correct.
Set the value of Ampere (In %)
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.
Run the conveyor belt.
Send the filled and sealed HDPE/Glass bottles on the machine belt.
By opening the screw cap ensure that the bottle passed below the heater is sealed by induction.
The bottle is sealed by Wad seal; screw cap can be screwed and unscrewed without disturbing the induction seal.
Ensure that the counter is also working.
Run the machine continuously.
Ensure the induction sealing checking intermittently.
Record the findings in the respective BMR.
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.
Precaution taken during Operation:
Please do not touch any Live Wire during Fault Finding.
Do not touch the Electrode while the machine is in operation.
Do not Discharge the Condensers directly. Use a Lamp to discharge it.
Challenge Test of Sensors:
| SNo. | Simulation | Procedure | Excepted Result |
| 1 | Bottle Jamming | Put some obstacle to block the flow of bottles running on the conveyor. | If the Jam Timer setting time expires “bottle Jammed at FNT/END” will be displayed. |
| 2 | Bottle Counter | Send capped bottle with foil inside the cap through the system | Production count and the number of Total Bottles will increase |
| 3 | No Foil Detector | Send bottle without foil inside the cap through the system | The detector will sense the foil; if foil is not there it will send the signal to the system and buzzer to be beep. |
Frequency of Challenge test:
Before start of bottles induction sealing of new Batch or days operation.
Whenever bottle induction sealing machine stopped and re-starts after every breakdown or Lunch, Tea break etc.
Cleaning:
Type-A Cleaning procedure:
During batch to batch change of the same product, Type-A cleaning shall be performed.
Switch “OFF” the mains of machine.
Remove the bottles if any from machine and discard it.
Remove and discard the left over quantity of Rejected bottles from the rejection box and record in BMR.
Clean the conveyor including railing guide using dry lint free mop.
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 the empty bottles if any from machine and discard it.
Remove and discard the left over quantity of Rejected bottles from the rejection box and record in BMR.
Clean the conveyor including railing guide using wet lint free mop 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 usage log book.
Note:
Ensure that no sharp or pointed instrument like knife blade etc. is used to clean the heating plate. This will damage the heating plate.
Also ensure that no wet mop or water comes in contact with the sensors.
Clean the sensors using dry mop only.
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.