White Paper Daily Visual Balance Check Cleaning and Leveling The pharmaceutical industry and other businesses that manufacture fine chemicals and substances typically have very strictly regulated areas, for example in analytical procedures. As stated in the SOP, users are obligated to subject their balance to a daily visual balance check. This consists of a test on cleanliness and leveling. This procedure should be carried out on a daily basis and should conform to GxP. Contents 1. Defining the test sequence 1.1 Defining the method 1.2 Defining additional test sequence parameters 2. Defining the task 2.1 Automatic call-up 2.2 Defining manual call-up 3. Activating the “Test Sequence” function key White Paper Daily Visual Balance Check Summary The pharmaceutical industry and other businesses that manufacture fine chemicals and substances typically have very strictly regulated areas, for example in analytical procedures. As stated in the SOP, users are obligated to subject their balance to a daily visual balance check. This consists of a test on cleanliness and leveling. This procedure should be carried out on a daily basis and should conform to GxP. Introduction Would you like to carry out the visual balance check on a daily basis? The specifications are as follows: • The visual balance check has to be carried out once a day on a daily basis. • Any staff member can carry out the test again before they start work, if they so wish. • All tests are to be recorded and documented in the operations log. The user must inform the supervisor if the test requirements are not met; the balance must be clearly marked and subsequently checked by a balance specialist. Should the visual balance check not be carried out, the balance cannot be used. The system may be used again once it has been ensured that a visual balance check has been performed. Information METTLER TOLEDO 2 White Paper Proposed solution We recommend the following settings in the balance menu for the Excellence Balance Line (the proposed settings are based on the English menu settings). 1. Defining the test sequence The test sequence for the visual balance check must first be defined. The test sequences are in the following Adjust/Test menu: User Settings > System > Adjust/Test Define the test sequence in the following menu: Adjust/Test > [Test Sequences… Define] > Test Sequences Open a new test sequence by defining an unassigned test sequence. Test Sequences > [Test Sequence 1… Define] > Test Sequence Setup Test Sequence Setup • Select a unique name. The selected name will appear later in the dialogs, in the report and also in the menus as a heading. • Select “Standard” in the “Preparation Instructions” menu field. These instructions prompt the operator to clean and level the balance. Test Sequence Visual Check Setup Version 2 Name Visual Check Preparation Instructions Standard Method SERVICE Action if Failure Warning Instructions If Failure None Code to Unblock 123456 Enter in GWP History Yes [ok] 1.1 Defining the method In the test sequence, the SERVICE method is selected as the method. Test Sequence 1 > [Method… Define] > [SERVICE… Define] In the SERVICE method, deactivate all Status Items. By doing so, the pre-warning time becomes inactive and therefore irrelevant. White Paper METTLER TOLEDO 3 White Paper 1.2 Defining additional test sequence parameters Now that the method has been defined, go back to the Test Sequence menu. Method SERVICE [ok] > Method [ok] > Test Sequence Setup Test Sequence Setup Test Sequence Visual Check Setup Version 2 • Under “Action if Failure” you must define the following menu items under “Warning”: - Warning Message: Standard - Time Interval: 1h - Max. Warning: 1 Name Visual Check Preparation Instructions Standard Method SERVICE Action if Failure Warning Instructions If Failure Standard Code to Unblock 123456 Entry in GWP History Yes With this, the administrator makes it possible for the operator to postpone the visual balance check for a max. of 1 hour, in case the current time is not convenient. Afterwards the balance becomes blocked. [ok] • Under “Instructions if Failure” selecting “Standard” provides the user with helpful troubleshooting measures in the event of an error. These measures correspond to the standard instructions usually detailed in an SOP. • Under “Code to Unblock” there is the option to assign a release code for the test sequence. (Note: It is advisable to lock the system menu for the operator). • For complete traceability of the measurement results, you must select “Yes” for the “Entry in GWP History” menu option. Save your settings: Test Sequence [ok] > Test Sequences [ok] > Adjust/Test Information METTLER TOLEDO 4 White Paper 2. Defining the task After the test sequence has been set up, you must then define the tasks. To do this, change over to the “Tasks” submenu: Adjust/Test > [Tasks … Define] 2.1 Automatic call-up To perform the test sequence automatically on a daily basis, you must then define the tasks. To do this, open an unassigned task: Tasks > [Task 1… ] > [On … Manual] > Task Setup Task Setup • Assign the test sequence you have created to the task. • Change the “Starting Method” to “Interval”: - Set the interval start time to a desired time of the day (E.g. 10:00). - Select 1 day as “Interval”. • With “Defined Days”, you can define any exceptions for the daily call-up. Ensure that all days are selected here, except “Saturday” and “Sunday”. • With “Defined Users” you can define any exceptions for the users. Ensure that all users are selected here. Task 1 Setup Test Sequence Visual Check Starting Method Interval Defined Days Define Defined Users Define [ok] In this way, the test sequence is started at 10:00 on a daily basis and prompts the operator with a dialog to carry out the visual balance check. Save your settings: Task 01 [ok] > Tasks 2.2 Defining manual call-up To ensure that the user can start up the test sequence by pressing the “Test Sequence” button, you will need an additional task, so open an unassigned task: Tasks > [Task 2… Define] > [On … Manual] > Task Setup With the exception of the “Starting Method”, the process is identical to the task described in 3.1. • Define the “Starting Method” as “Manual”. Save your settings and exit the system menu: Task 02 [ok] > Tasks [ok] > Adjust/Test [ok] > Exit You are now back in weighing mode. Task 2 Setup Test Sequence Visual Check Starting Method Manual Defined Days Define Defined Users Define [ok] In this way, the test sequence can be called up manually using the test sequence function key. White Paper METTLER TOLEDO 5 White Paper 3. Activating the “Test Sequence” function key To start the test sequence manually, you will require the “Test Sequence” function key. This is activated in the following menu: User Settings > Applications Menu > [Function Keys … Define] Activate the Test Sequence selection box which should appear in the first 5 items. Exit the menu: Function Keys [ok] > Applications Setup [ok] > Weighing Mode Additional White Papers for GWPExcellence™ www.mt.com/GWPExcellence Mettler-Toledo AG Laboratory & Weighing Technologies CH-8606 Greifensee, Schweiz Tel. +41 44 944 22 11 Fax +41 44 944 30 60 Technische Änderungen vorbehalten © 09/2009 11793528 V1 Mettler-Toledo AG Global MarCom Switzerland Information METTLER TOLEDO 6
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