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Daily Visual Balance Check Cleaning and Leveling

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

Contents

The pharmaceutical industry and other businesses that manufacture fine che-micals 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 clean-liness and leveling. This procedure should be carried out on a daily basis and should conform to GxP.

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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 sub-ject 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.

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We recommend the following settings in the balance menu for the Excellence Balance Line (the proposed settings are based on the English menu settings).

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.

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 there-fore irrelevant.

1.

1.1

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]

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4Information METTLER TOLEDO

Test Sequence

Visual Check Setup

Version 2

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

[ok]

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

Under Action if Failure you must define the following menu items under Warning: - Warning Message: Standard - Time Interval: 1 h - Max. Warning: 1

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.

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

1.2

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After the test sequence has been set up, you must then define the tasks. To do this, change over to the Tasks sub-menu:Adjust/Test > [Tasks Define]

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.

Save your settings:Task 01 [ok] > Tasks

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.

2.

2.1

2.2

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.

Task 2 Setup

Test Sequence Visual Check

Starting Method Manual

Defined Days Define

Defined Users Define

[ok]

In this way, the test sequencecan be called up manually using the test sequence function key.

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6Information METTLER TOLEDO

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 fol-lowing 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

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Mettler-Toledo AG Laboratory & Weighing TechnologiesCH-8606 Greifensee, SchweizTel. +41 44 944 22 11Fax +41 44 944 30 60

Technische nderungen vorbehalten 09/2009 11793528 V1 Mettler-Toledo AGGlobal MarCom Switzerland