SOP for Operation and Cleaning of Automatic Cartoning Machine (CP-150)

Automatic Cartoning Machine is used for Packing blisters/Strips inside the carton in secondary packing areas in Pharmaceuticals.

1.0 Purpose: The purpose of this standard operating procedure is to lay down the procedure for Operation and Cleaning of Automatic Cartoning Machine (CP-150).

2.0 Scope: This SOP is applicable to the Operation and Cleaning of an Automatic Cartoning Machine (CP-150) in a manufacturing facility at Pharmaceuticals.

3.0 Responsibility: 3.1 Officer/Sr. Officer is responsible for ensuring the activity has been performed as per the given SOP.
3.2 The head of the department is responsible for the effective implementation of this SOP.
3.3 Head QA is responsible for ensuring compliance with this procedure.

4.0 Operation:

4.1.1 Check the CLEANED label is affixed to the machine.
4.1.2 Take a line clearance from the IPQA person as per the BPR.
4.1.3 Remove the CLEANED label from the machine and attach it with BPR. Affix the UNDER PROCESS label on the machine indicating the product details for which it is to be used.
4.1.4 After getting the line clearance from the Executive IPQA & Executive Packing, mount the cartons on the carton carrier & mount the leaflet on the leaflet holder.
4.1.5 Set the leaflet holder as per the leaflet size.
4.1.6 Set the carton carrier as per carton size.
4.1.7 Set the bottle to carry belt as per bottle size and also set the sensors as per the requirement.
4.1.8 Adjust the inlet track, and guide plate of the machine for easy movement of the bottle.
4.1.9 Adjust the fingers for holding cartons as per carton size.
4.1.10 ON compressed air pressure (6 kg/cm²). for opening of cartons.
4.1.11 Adjust magazines of cartons, bottles, and leaflets using dials for specific dimensions.
4.1.12 Go to the system setting in HMI. (Human-machine interface):

4.1.12.1 Put Operation password for operating key Level 1.
4.1.12.2 After filling in the Password press Enter key.
4.1.12.3 Showing the following function Key displayed on the screen:

• Carton vacuum
• Leaflet vacuum
• Carton top support
• Turntable
• Conveyor belt

4.1.12.4 During On. Condition Keys show “GREEN” color.
4.1.12.5 Select run mode by run mode KEY Machine automatically runs select by the automatic mode.
4.1.13 Start the machine & pass a few bottles through the track withdraw 2 to 3 packed cartons and check the packing as per BPR (bottle, Leaflet, and carton).
4.1.14 After satisfactory setting of the machine, run the machine continuously.
4.1.15 After completion of the operation the Executive — production should enter the details in the logbook as per the “Making entry in Equipment Usage logbook” SOP.
4.1.16 Press “CONTROL OFF” and stop the machine.
4.1.17 Close all guards and ensure the main control cabinet is closed.
4.1.18 The rear cover is in a locked position.
4.1.19 Collect accepted packed cartons and separately collect rejected cartons.
4.1.20 Open rejected cartons and repack as per requirement.
4.1.21 After completion of the operation, a loose vacuum of a carton, leaflet and Switch OFF the machine.
4.1.22 OFF compressed air supply.
4.1.23 Clean the machine with a dry lint-free cloth.
4.1.24 Affix the “TO BE CLEANED” label on the machine.

4.2 Cleaning:

4.2.1 Check the previous status label and confirm the details on it.
4.2.2 Ensure the machine is switched OFF.
4.2.3 Remove any remnant of the previous batch.
4.2.4 Clean the machine with a lint-free cloth.
4.2.5 Clean magazines of bottles, cartons, and leaflets.
4.2.6 Change PUSHER as per carton specification.
4.2.7 Atlix the “CLEANED” label.
4.2.8 Record the cleaning details in the respective Equipment Log Book.

5.0 Distribution:
Controlled Copy: Production
Original Copy: Quality Assurance

6.0 Abbreviations:
SOP: Standard Operating Procedure
Sr.: Senior
IPQA: In-process quality assurance