Regulation Daily Balance Testing

Can you guarantee your routine testing is secure?

Routine balance testing is essential in order to ensure that performance remains within defined tolerances. An out of tolerance balance can cause costly major errors in all analyses. Ensuring balance testing remains current is a challenge and, without strict procedures in place, it is easy for testing protocols to become compromised. Our new and innovative solution, GWP® Excellence, is built into the balance software providing a secure method for ensuring tests are always carried out correctly and according to a predefined schedule.

Regulations
The US Food and Drug Administration (FDA) states that laboratory balances should be tested daily in accordance with cGMP general requirements (CFR – Code of Federal Regulations, Subpart 1: Laboratory Controls, 211.160 (b)(4)). Several other standards also recommend the regular testing of measuring devices: The Good Laboratory Practice (GLP), ISO 10012 Part 1 for Quality Assurance Requirements for Measuring Equipment and ISO 9001 Section 7.6 Control of Monitoring and Measuring Devices.

Built-in Solution
GWP® Excellence consists of a range of safety features incorporated into Excellence XP and XS Balance software. All test weights and test procedures are easily implemented in the new firmware. The balance prompts the user when a test is due ensuring that critical tests are never missed. The administrator can define how many attempts are allowed to pass a test before the balance is blocked. The balance provides step-by-step instructions throughout the test procedure ensuring that laboratory managers are always certain that test SOPs have been followed and that users are not concerned with which test must be carried out when and how. The new firmware, Version 5.10, is available in all new XP/XS Balances and can be downloaded free for existing XP/XS Balances.

Testing Security
GWP® Excellence monitors dates and times for each implemented test. A user may postpone a test an allowed number of times but it is not possible to ignore it. Laboratory managers can be sure that each defined test has been performed within the allowable time period. GWP® Excellence can also be used as a reminder of the annual maintenance service check and for weight recalibration ensuring a full circle of testing security.

The need to test
Every balance is subject to drift, i.e. the slow change of metrological characteristic value over time for a balance under constant or stationary conditions, and this may affect results. Changes in the ambient temperature have a major impact on measurement results. Other external influences to be considered include static electricity, magnetic interference, air currents and vibration transfer. METTLER TOLEDO’s Good Weighing Practice® guidelines includes everything necessary to get the best results from every balance.
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