Domino, Purpose:
Domino, To lay down the procedure for operation of ink jet printer (Domino A-Series A-220 GP Printer) in order to comply with cGMP at the Packaging area.
Domino, 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
[][]To follow the laid down procedure
Executive, Packaging
[][]To monitor and check the procedure is followed
Manager, Production
[][]To implement this correctly
Head of Plant Operation
[][]To agreed this SOP
Head of Quality Assurance
[][]To approve the SOP
Procedure :
Precaution:
[][]The working person must follow the safety procedures of work.
[][]For any trouble put OFF the main switch first and protect Materials.
[][]Check electric connection and mechanical set up.
Machine Operation
[][]All Operations of machine are controlled by the following different keys/buttons. There are two types of buttons.
[][]Permanent buttons with fixed functions.
[][]Function buttons (soft keys) with functions that change.
[][]To Machine start –up from Power off, Press & hold the Power on/off button for 2 sec.
[][]The green indicator on the power button is lit.LED begins to flash
[][]The status bar at the top will display any faults if got.
[][]The Home screen will display. Icon will show at top right corner.
[][]Press & hold the Jet start/stop button for 2-3 sec.
[][]The green indicator on the start/stop button begins to flash.
[][]The status bar displays faults or jet starting.
[][]The start-up takes approximate 70 sec.
[][]The status indication shows “Start”
[][]The printer is now ready to print message. Icon will show up at top right corner.
[][]To Machine Shut-Down from ready to print or standby, Press the Power on/off button for 2 sec.
[][]The green indicators on the Jet start/stop button & power on/off button begins to flash
[][]A timer is shown on the bottom right screen & display
To write new message from the Home Screen:-
[][]Press the “Message” button.
[][]Press the “New” button.
[][]Enter a “Name” for the message & press “Enter”
[][]Ensure the “Message settings”.
[][]Press “Add field” button.
[][]Select “Text” by cursor button & press “Enter”.
[][]Press “Add field” for 2nd portion & select “User defined”.
[][]Write date or Numbers.
[][]Repeat same procedure for “New” & “Enter” lines.
[][]Once the message is complete, press “Enter”.
[][]Save this message & press “Enter” again to return to main screen.
[][]To print the messages press the “Start Print” button.
To edit message saved in the message store:-
[][]Press “Edit” button .Message settings are highlighted.
[][]Use the keyboard to select the parameters wish to change.”W” for width.
[][]Press “Next Field” one of the message fields will be highlighted
[][]If required press “Next Field” again until the required field is highlighted.
[][]Change the Field settings.
[][]Press the “Edit Text” button. The message text can then be edited.
[][]Press the “Enter” button to “Save as”.
To print Message from the Home screen :-
[][]Press the “Message button”
[][]Use the cursor buttons to move up & down to high light the message to be printed.
[][]Press the “Start Print”.
To Print adjust any print parameters:-
[][]Press “Print adjusts”. When pressed you will see the screen.
[][]Press the relative character to adjust the options.
To insert LOGO from Home Screen:-
[][]Press the “Message” button.
[][]Press the “New” button.
[][]Enter a “Name” for the new message & then press “Enter”.
[][]Set the “message settings” before selecting to the “Add field”
[][]Select “logo” from the “Field select” screen using the cursor buttons & press “Enter”.
[][]From the selection screen select the logo by using the up/down cursor buttons. When the required logo is displayed on the screen press “Enter”.
[][]The logo will now be displayed in message screen. Field settings can be changed at this point. Ensure the correct font size is selected on the message settings. Screen.
[][]Press “Enter” to save the message & then press “Enter” again to return to the store screen. Press “Start Print” to print the highlighted message & return to the Home page.
Annexure:
Annexure-I : Equipment log book