1.0 Objective: The purpose of this SOP is to lay down the procedure for the Carton 2D Barcode Printing Machine.
2.0 Scope: This SOP is applicable for the Operation of a Carton 2D Barcode Printing Machine in a Manufacturing facility in Pharmaceuticals.
3.1 Operator Production shall be responsible for the operation of the Carton Barcialc Pruning Machine.
3.2 Officer / Sr. Officer Executive / Sr. Errcuilre Production shall be responsible for ensuring the activity has been performed as per the procedure.
3.3 Manager I Department Dead shall be responsible for the effective Implementation of this procedure.
3.4 Head – Quality / Quality Assurance or his / her authorized designee shall be responsible for ensuring compliance with the procedure.
4.1.1 Domino inkjet BAR code printer: It prints information in the form of codes.
4.1.2 Inkjet printer: It prints Batch No., Mfg. Date, Exp. Date, Lic. No.
4.1.3 Conveyor belt: Use to convey the printing process.
4.1.4 Computer system: Use to provide information.
4.2.1 Check and ensure Carton 2D – Barcode Printing Machine is cleaned and affixed the “CLEANED” label as per the status labeling SOP.
4.2.2 Remove the “CLEANED” label and affix the ‘UNDER PROCESS’ label having the details of the particular batch to be operated.
4.2.3 Take Line clearance from the IPQA person.
4.2.4 Switch ON printing assembly (Domino printer, Ink Jet printer, Computer).
4.23 Clear all the remnants of previous products and information, command in software, and Ink let printer.
4.2.6 Fill suitable ink In the Ink Jet printer and mount the cartridge of the Domino printer.
4.2.7 Command information in Ink Jet printer related to the product for which cartons have to be printed.
4.2.8 Command to Domino printer using software for 2D BAR CODE.
4.2.9 Switch ON the conveyor belt and compressed air.
4.2.10 Set conveyor speed according to carton size and printing space that has to be printed.
4.2.11 Print the carton according to the instructions in BPR.
4.2.12 Perform initial checks for carton printing and record in BPR. After satisfactory results of initial cheeks continue carton printing. Remove rejected cartons and tear them.
4.2.13 Record the operation details in the respective Batch Packaging Record and Equipment Log Book.
4.2.14 After completion of carton printing, stop the conveyor and printers and save performed information.
4.2.15 Affix the “TO BE CLEAN” label on the machine.
4.2.16 Keep printed cartons separately in the area.
4.3.1 Clean printers and conveyor belts with a dry lint-free cloth.
SOP: Standard Operating Procedure