my.chemie.de
With an accout for my.chemie.de you can always see everything at a glance – and you can configure your own website and individual newsletter.
The U.S. Pharmacopoeia Convention(USP) has recently published a revised version of its mandatory chapter 41 (Balances) plus amendments to chapter 1251 (Weighing on an Analytical Balance). Effective 1 December 2013, the revised chapters mean pharmaceutical companies are now facing the problem of compliance with the new requirements. These amendments define the changed test procedures for scales (US: balances) that apply both to the US pharmaceuticals industry and for companies that export to the USA.
Scale users and manufacturers have long criticised the fact that the USP’s general chapter 41, “Balances”, uses extremely vague formulations and compliance with the rules is hard to achieve. In addition, frequent mention has also been made of the fact that the general chapter 1251, “Weighing on an Analytical Balance”, no longer reflects the latest weighing techniques. The revision of both chapters as part of the second supplement to USP 36-NF 31 is intended to help medicine manufacturers and suppliers ensure precision, and thus avoid repeated testing and the onerous costs this entails. Here, Mettler-Toledo’s global weighing standard Good Weighing Practice™ (GWP®) can help customers to implement the new standards in a structured and effective manner.
Fig. 1 With GWP® Verification, the minimum weight can be determined precisely for each set of scales.
Compliance with the new requirements for general chapter 41 is mandatory. The revised chapter defines
a fairly sophisticated evaluation procedure for scales. Details are provided of precision and repeatability testing for calibrated scales, such as are used to weigh analytes for substance assays. Since precision can be verified only with the use of weights that correspond to at least 5 % of the scales’ capacity (with weights under 5 %, evaluation of systemic deviations is too imprecise), the selection criteria for specimen weights have also been modified appropriately.
General chapter 1251 contains additional details about the new procedures, while expanding the scope to cover all scales that are used in analysis procedures. This also envisages a risk-oriented approach to the verification of scale performance. In particular, the text recommends only weighing net samples that weigh considerably more than the minimum weight. This takes into account fluctuations in scale performance that can be traced back to varying environmental factors or the scale operator. This requirement refers expressly to the sample weight itself and does not cover the tare vessel. Beyond this, the recommendations for daily tests have been withdrawn – probably the most important change for pharmaceutical manufacturers. This change is likely to bring about huge time savings, which, assuming scale precision can be guaranteed, will also enable a corresponding reduction
in costs.
Fig. 2 GWP® Verification helps manufacturers optimise their operating procedures (SOPs).
While the new scale chapters imply the avoidance of unnecessary testing – so as to ensure the retention of production margins in the fiercely-contested pharmaceuticals market – the text nonetheless makes it clear that this option must in no circumstances influence the precision of the scales. The GWP® weighing standard from Mettler-Toledo can help manufacturers ensure compliance with the new USP rules.
GWP® verification is tailored precisely to match the respective scale applications and is a unique, risk-oriented service that helps to avoid superfluous or incorrect testing. Since the minimum weight and measurement uncertainty must be determined for each set of scales used within the weighing process, manufacturers not only optimise their operating procedures (SOPs) while ensuring a uniform level of product quality and successful audit results, but, in addition, avoid costly legal disputes and payments of fines on account of products whose composition is inadequate or which does not comply with the stipulated requirements.
Daily manual testing is finally a thing of the past. This gives manufacturers of pharmaceuticals the opportunity to improve their test equipment monitoring for scales and take a major step towards ensuring that their products remain safe, effective and profitable. Thanks to the unique, systematic guidance provided by the GWP® Verification Service, consistent weighing quality – and thus uniform product quality – can be integrated into pharmaceutical manufacturers’ daily production processes without this involving a burdensome schedule
of excessive testing.
Literature:
Literatur beim Autor
1 kg Redefinition: Everything different, nothing changes
A new definition of the kilogram was necessary, in order to ensure the measurement unit is independent from a physical object. more
Formulation is a relatively common procedure in industries such as pharmaceuticals, cosmetics, chemicals and food. more
Everything you need to know about Laboratory Balances
Over the years, we have put together a selection of the most commonly asked questions in our Laboratory Balance and Scale Q&A Guide. more
Fast and Accurate Precision Weighing Even in Difficult Conditions
These extremely durable balances are designed to withstand accidental overload, harsh chemicals, dust and dirt more
Ideal Weighing Routine with Convenient Operation and High Precision
The combination of reliable weighing performance and ergonomic operation makes the XSR analytical balances for the strong routinier, even under harsh conditions under the fume hood more
Taking Weighing to New Limits: XPR Micro and Ultra-micro Balances
With the model XPR6UD5, Mettler-Toledo presents the first ultra-micro balance on the market, delivers unique 0.5μl resolution more
Choose a proper weighing accessory for your balance
Balance accessories for your laboratory balance can help to simplify your processes and ensure you get the accurate results you want. more
Analytical Excellence to Improve Customer Processes
METTLER TOLEDO's comprehensive product range provides users with flexibility and precision in every application plus outstanding quality and functionality. more
Mettler Toledo opens new Competence Center in the Middle-East
METTLER TOLEDO has launched its new Dubai Free Zone Competence Center. This new facility will offer advanced analytical support for all industries operating in the Middle East and North Africa. It will also provide hands-on equipment training for METTLER TOLEDO’s range of products, which ar ... more
12 Months of Better Results from Mettler Toledo
Mettler Toledo presents a special offer for 2016 - a limited-edition, full-color lab calendar. More than a way to track days and dates, this 12-month calendar will provide a series of enlightening topics devoted to ensuring weighing accuracy in all critical lab processes. Using calendar pag ... more
New Q&More Online Portal: A Knowledge Network for Laboratory Professionals
The English version of the q&more online portal is now available online. The q&more portal was developed in a unique cooperation between succidia AG and CHEMIE.DE Information Service GmbH, and is supported by METTLER TOLEDO. It is aimed specifically at decision-makers, and uses attractive c ... more
“Game over” for the Paris kilogram
For about 200 years, any mass given in kilograms, grams and micrograms referred to a defined artifact accessible in only a single location on earth. A small metal cylinder had represented one kilogram since the metric system was introduced in France. Its successor became world famous as the ... more
User interfaces for presenting traceable measurement results
Easy access and navigation of historical measurement data stored in central laboratory software systems is important to support the documentation and, in particular, the traceability of measurement results. For some instruments it is also useful to grant users access to past measurement data. more
Reduced lead times for added value in the lab
The process industry is seeing manufacturing structures change, production chains becoming global and higher requirements placed on manufacturing processes. Businesses need to adapt to declining sales volumes and the demand for more specific product characteristics. more
Christian Müller-Schöll, born in 1966, studied mechanical engineering at the University of Stuttgart, Germany, and graduated as Diploma-Engineer. At the ZHAW Zurich University of Applied Sciences he obtained a certificate for Integrated Risk Management. He headed the primary mass calibratio ... more
Igor Knapp, born in 1968, is a qualified computer science engineer and Team Leader for Interaction Design at Mettler-Toledo GmbH. In 1993, he successfully completed a design education at the Basel School of Design (Switzerland) and subsequently worked for more than seven years in corporate ... more
Wolfgang Boos, born in 1965, initially trained as an Information Technician before studying Technical Computer Science at Flensburg University of Applied Sciences (Germany), graduating with a diploma degree. He subsequently worked as a software developer at the Forschungszentrum Jülich, Ins ... more
XPR Analytical Balances: Weighing Solutions without Compromise
XPR Analytical Balances are the right choice for challenging weighing applications, such as weighing the smallest sample sizes, with exceptional accuracy and a readability of 5 micrograms. Save time, money and materials, and invest in a balance that consistently delivers results you can tru ... more
Precision Balances Designed for Easy Operation
In today's high pressure research and manufacturing environments, having the right equipment is key to achieving quality and efficiency. With customers demanding short lead times and reliable delivery dates, you need a balance you can trust to deliver accurate results - and which is conveni ... more
The Essence of Weighing And More
Daily weighing routines are easy and efficient thanks to the ergonomic design features of the NewClassic ME balances. Essential functionality is at your fingertips to provide you with accurate and reliable weighing results day after day. But there is more. These robust all-round balances no ... more
GWP® ensures efficient weighing lifecycle management, with advice on balance selection, calibration and routine testing. (…)
Calibration proves that the equipment runs within permitted tolerances and delivers reproducible measurements that lead to consistent product quality (…)
The q&more concept is to increase the visibility of recent research and innovative solutions, and support the exchange of knowledge. In the broad spectrum of subjects covered, the focus is on achieving maximum quality in highly innovative sectors. As a modern knowledge platform, q&more offers market participants one-of-a-kind networking opportunities. Cutting-edge research is presented by authors of international repute. Attractively presented in a high-quality context, and published in German and English, the original articles introduce new concepts and highlight unconventional solution strategies.
> more about q&more
q&more is supported by:
- © 1997-2019 LUMITOS AG, All rights reserved
q&more articles
