1.0 OBJECTIVE
To lay down the procedure for the operation of Automatic Cartoning Machine.2.0 SCOPE
This SOP shall be applicable for the operation of Automatic Cartoning Machine in the packing area.3.0 RESPONSIBILITY
3.1 Execution: Operator3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY
HOD-Production / Assigned Designee5.0 PROCEDURE
5.1 Production person shall ensure the cleanliness of the Machine & area and ‘CLEANED’ label on it.5.2 Before starting the operation production person get the line clearance from Q.A person by writing the status label with Product Name, Batch Details to equipment & area.
5.3 Start the compress air supply. It should be 6-8 kg/cm².
5.4 Get the safety key from the packing office key box insert the key and turn the machine to JOG MODE.
5.5 Put ON the main switch.
5.6 Go to SET data.
5.7 Enter blister unload number as per packing configuration specified in Batch Packing Record.
5.8 Go to Production data.
5.8.1 Enter 3 digit password.
5.8.2 Enter product name batch no, batch size, mfg, exp. as per Batch Packing Record.
5.9 Press the switch button and enter all operation in ‘AUTO’ mode.
5.10 Check the dropping of blisters.
5.11 Adjust the bucket width as per carton dimension.
5.12 Adjust hopper and compression plate as per pack size.
5.13 Base plate of hopper should be in line with bucket chain/belt of the conveyor.
5.14 Adjust the hopper such that inner left sidewall of hopper should match with the inner side of fix bucket wall.
5.15 Check position of cartons in carton magazine.
5.16 Check leaflet position in leaflet magazine.
5.17 Check suction of cartons with help of jack and machine hand wheel.
5.18 Check forming of cartons.
5.19 Check tucks and closes of cartons.
5.20 Check suction and folding of leaflets.
5.21 Check feeding of product and leaflets in cartons.
5.22 Do all the adjustments carefully.
5.23 Use the Scale Reading, Cam Timing and change part Identification chart for minimizing the errors.
5.24 Check that the blister machine supply is made ON and then put ON the carton supply.
5.25 Get the respective metal letters issued by a pharmacist as per required batch details to be overprinted/ embossed as per respective BPR and record in metal letter issue and destruction record.
5.26 Engage the inking roller and check for good quality of batch printing remove the overprinted specimen and get it approved from QA attach the specimen to BPR.
5.27 Check for correct quantity of blister release from the magazine.
5.28 Put the machine in auto mode remove the key and keep it in key box of packaging office.
5.29 NFD Challenge test
5.29.1 Check the interlocking of the sensor is proper.
5.29.2 Check the No Blister No Carton performance.
5.29.3 Check the empty carton challenge test at the discharge end.
5.29.4 Perform the challenge test twice in a day and record it in F/PR/061.
5.30 Start the packaging activity.
5.31 Start the leaflet by activating F2 key and check for correct operation of leaflet insertion.
5.32 Check for the correct operation of rejection mechanism for the cartons or missing of leaflets.
5.33 Load the cartons and /or leaflets when the lower level is crossed and the blue lamp starts flashing on the beacon.
5.34 Use normal stop push button only for stoppage of the machine unless there is an emergency.
5.35 If the packing activity of the same batch is continued next day then first remove the specimen of overprinted/ embossed carton and get it approved from QA before starting the line.
5.36 After completion of batch/ product packaging operation affix ’To be Cleaned’ status label.
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 BPR: Batch Packing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
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