Sticker labeling machine, Purpose:
Sticker labeling machine, The purpose of this SOP is to describe the Set up, Operation and Cleaning of Sticker labeling machine in order to comply with cGMP standard.
Sticker labeling machine, Scope:
This SOP is applicable for the Packaging Area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Operation and cleaning of the Sticker labeling machine
[][]Maintaining Equipment Log Book.
Executive, Packaging
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly
Manager, Quality Assurance
[][]To approve the Document
Annexure:
N/A.
Procedure:
Precaution :
[][]Always turn OFF the machine before threading the label web through the machine.
[][]Keep hands away from moving machine parts while machine is in operation.
Machine Assembling
[][]Before operation assemble the machine accessories that are necessary for operation.
[][]Set the Batch no. Mfg date and Exp date on the hot stamp Printer.
[][]Set Label and carbon roll.
Machine Operation
[][]Connect the electrical cable and compressed air line.
[][]ON main power switch.
[][]Press ENTER on the PLC.
[][]Select mode form PLC as specified.
[][]Switch ON the turn table.
[][]Press Label ON from PLC.
[][]Press Print ON from PLC.
[][]Press counter ON from PLC.
[][]Adjust label on the label roll of the machine.
[][]Press RUN button on the PLC.
[][]Record the machine operation start time & end time and other parameters on the ‘Equipment Log Book’.
[][]Machine Dismantling
After operation disassemble the machine accessories.
Remove the hot stamp printer for changing Batch no. Mfg date and Exp date.
Machine Cleaning
[][]Remove dusts from the machine with a vacuum cleaner.
[][]Clean all the machine parts with dry lint free cloth then with wet mop.
[][]Swab the machine body and change parts with lint free cloth.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the Equipment Log Book.