A simple, fast and secure weighing process is important for the quality control lab of Grünenthal Pharma AG in Mitlödi, Switzerland. Performing fast and accurate statistic checks of randomly taken samples and documenting all the weighing results are the main tasks required of a balance. METTLER TOLEDO’s XP205DR is their balance of choice.

Aim for AdvancementGrünenthal is an international pharmaceutical company with research and production facili-ties in Switzerland. Their factory in Mitlödi, Switzerland manufactures pharmaceutical products in suppository, capsule or tablet form. As part of their quality control, they rely on METTLER TOLEDO’s AT261 semi-micro balance to perform daily routine tests satisfactorily.

Grünenthal Pharma SwitzerlandStatistical quality control of medicines

Weighing of tablets

Uniformity of Single-Dose MedicinesDetermined with Excellence Plus Balance

Laboratory Case Study

Pharma Solutions

XP205DR Analytical Balance

Mettler-Toledo AGLaboratory DivisionIm LangacherCH-8606 Greifensee, Switzerland

Subject to technical changes.© Mettler-Toledo AG 07/09Printed in SwitzerlandGlobal MarCom Switzerland

To comply with the ever more stringent regulations of GMP, they recognized the need to look for a replacement.

Balance and Operator – Seamless CooperationGrünenthal’s choice was the Excellence Plus XP205 DeltaRange Analytical Balance from METTLER TOLEDO. It has a weigh-ing range from 0–81 g and 0-220 g with readabilities of 0.01 mg and 0.1 mg respectively.

One of the most important appli-cations in the quality control lab involves the determination of uni-formity in single-dose preparations. In accordance with the European Pharmacopoeia, 10 units of the sample, e.g. suppositories or tab-lets, are collected randomly. After individual sample weighing, the average weight is calculated. This mass should not differ by more

Single-dose suppository being weighed and calculated by balance's built-in statistic applicaition.

than 5% from the average in more than 2 of the 10 samples. In addi-tion, none of the samples may dif-fer more than twice that percentage from the average weight.

These complicated calculations are taken care of by the balance’s built-in statistic application. The user is guided step-by-step through the weighing process. All previ-ously entered data results, such as sample identification and gener-ated weight values, are fully trace-able and can be printed out easily. Thanks to weighing process au-tomation, weighing time is greatly reduced and all results are securely documented. Small Features, Great HelpWeighing efficiency is further in-creased thanks to the revolutionary design of the grid weighing pan, SmartGrid, which enables weigh-ing-in without causing any turbu-

lence to the weighing chamber. Therefore, results can be obtained with high level of accuracy in a much shorter time.

In order to comply with GMP regu-lations, all weighing results have to be printed out and documented. METTLER TOLEDO offers a stand for the printer which guarantees vibration-free printing and saves laboratory work space. Mr. Roman Schütz, responsible for equipment and laboratory control, supervises the balances in the quality control lab. "The balance is very user-friendly. The new Excellence Plus series gives the administrator the flexibility to set up the balance according to specific needs. The lock-in/out function, which allows settings protection to prevent improper balance use by other lab operators, is a great func-tion for me."

Dr. Peter Bethke, head of the labo-ratories in Mitlödi, continues: “We purchase from a supplier that we trust. If we are pleased with the product we will order more. Within the next few years, we will acquire more balances from METTLER TOLEDO. We find that METTLER TOLEDO offers good value products and we are impressed by all the services they provide.”

www.mt.com/xp-analytical