1.0 Objective: The Purpose of this SOP is to lay down the procedure for the Operation and cleaning of the Domino Thermal Inkjet Printer.
2.0 Scope: This SOP is applicable for the Operation and Cleaning of the Domino Thermal Inkjet Printer at the manufacturing facility in Pharmaceuticals.
3.0 Responsibility:
3.1 Operator Production shall be responsible for the Operation and Cleaning of the Domino Thermal Inkjet Printer.
3.2 Officer / Sr. Officer / Executive / Sr. Executive Production shall be responsible for ensuring the activity has been performed as per the procedure.
33 Manager / Department Head shall be responsible for the effective implementation of the procedure.
3.4 Head – Quality / Quality Assurance or his / her authorized designee shall be responsible for ensuring compliance with the procedure.
4.0 Procedure:
4.1 Operation:
4.1.1 Check and ensure that equipment is clean as per SOP.
4.1.2 Intimate IPQA for line clearance.
4.1.3 After line clearance from 1PQA person, put the “Status Label” of equipment and area duly filled and signed by the production person.
4.1.4 Switch ON the machine.
4.1.5 Enter the password.
4.1.6 After entering the password screen shall show a message like ‘Trail 1, Trail 2, and Trail 3.
4.1.7 Open Trial 1 and enter the batch number detail in it. Save the details.
4.1.8 Click EDIT to edit the field like text editing or data entry in the Trail 1 option. Click on Save As to save the new message.
4.1.9 Accept the new value and click Enter. The display will show “ON”. Click on “ON” and the machine will start printing the batch number.
4.2 Cleaning:
4.2.1 First clean the machine with a wet lint-free cloth to remove any dust and then finally clean it with a dry lint-free cloth.
5.0 Distribution:
Copy No.: 01 Controlled Copy: Production
Original Copy: Quality Assurance
Annexures: NIL
References: NIL
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