Wednesday, April 13, 2011

European scientists unveil research to protect water against bioterrorism

EU-funded DINAMICS project presented at inaugural Pharma Test Expo 2011 in Cologne, Germany. Innovations have applications for pharma and food testing

DINAMICS presentation at the Pharma Test Expo

Our drinking water will be safe from potential terrorist attacks thanks to four years of collaborative efforts by European scientists from eight countries working on the DINAMICS research project, visitors to the inaugural Pharma Test Expo 2011 in Cologne, Germany, learned on February 10.

Civilian security became a hot issue of concern following the terrorist attacks on New York’s World Trade Center on September 11, 2001, and the subsequent wave of anthrax letters.

The European Commission responded by co-funding the development of a new water quality warning system to help prevent bioterrorist attacks through its detection of dangerous infectious agents, such as bacteria and viruses.

Scientists representing seven of the 12 leading-edge technology companies and public research institutes involved in the over 7 million-euro DINAMICS project reported on the innovations made since the research began in 2007 at a workshop at the Pharma Test Expo 2011 sponsored by Provenion Engineering, a partner in the DINAMICS project and an exhibitor at the Expo.

Provenion Engineering Stand at the Pharma Test Expo

“The aim of the project is to develop an online monitoring system for detecting the presence of pathogens in drinking water,” said Dr. Sabine Müller, project manager at the German technology transfer center Steinbeis-Europa-Zentrum, which is currently in charge of financial and administrative management of the project as well as knowledge management and dissemination.

The project name, DINAMICS, reveals just how complex the research is. DINAMICS stands for Diagnostic Nanotech & Microtech Sensors.

The DINAMICS consortium brought together experts in the fields of:
  • Water supply Management,
  • Microbiological and molecular biology specimen handling,
  • Nanometric film technology
  • DNA nanostructures
  • Sensor and chip technology (optical and electronics)
  • Microfluidic components (chips)
  • Automated fluid handling
  • Microelectronics and signal processing
  • Scientific instrument engineering
  • Technology transfer
  • Product development

The team produced what Dr Müller called a “lab-on-a-chip platform” to quickly detect pathogens in water. Their prototypes, which should be on the market in several years as both handheld and stationary instruments, include a “cost-effective DNA sensor,” that is combined to microfluidic components and electrical and electronic circuits.

Presentation by Dr. Sabine Müller, Steinbeis-Europa-Zentrum

“These devices are next generation diagnostic tools for our water supply,” said Rolf Boetzel, Sales Manager at Provenion Engineering, the German company that engineered the prototype devices by integrating the various components of the project.

The beauty of the innovation is that it has possible applications in medical diagnostics, the food industry and in pharmaceutical testing, Boetzel added.

To view the DINAMICS workshop presented at the Pharma Test Expo 2011, click here.

For more information on the project, contact:

Dr. Christian Mittermayr, Project coordinator
Lambda GmbH
Tel. +43 7949 2090 3011
E-Mail Mittermayr@lambda.at
www.lambda.at

or

Dr. Sabine Müller
Steinbeis-Europa-Zentrum
Tel. +49 721 9351914
E-Mail: sabine.mueller@steinbeis-europa.de
www.steinbeis-europa.de

or

Rolf Boetzel
Business Development
Provenion GmbH
Tel.:+49 (0)8091-5505-17
E-Mail: r.boetzel@provenion.de
www.provenion.de


You may also want to view the DINAMICS dedicated website:
http://www.dinamics-project.eu/

Cosmetics Test Expo - New to the HuLST Expo for 2012

Inaugurating a new era in cosmetics testing



Cosmetics industry testing professionals, mark your calendars: The inaugural Cosmetics Test Expo 2012, to be held at koelnmesse in Cologne, Germany, next February 7, 8 and 9, will be the one trade fair you cannot miss. A HuLST Expo umbrella event.

Consumer trust is the key to the cosmetics industry, which in 2009 generated EUR 69.5 billion in Europe alone, about one-third of the global market. European consumers know their shampoos, hair dyes, moisturizers and cleansers, anti-ageing and anti-cellulite creams, antiperspirants, sunscreens, toothpastes and fragrances are safe.


Product safety is the backbone to consumer confidence, but it is not the only strength of today’s cosmetics industry. Consumers demand that products work, that they deliver on their promises. And in recent years, consumers are looking for more natural products. How does the cosmetics industry meet these demands?

Testing is the only means to ensuring cosmetics are safe, that they work and can be formulated with more natural ingredients.

Cosmetics Test Expo 2012 will showcase the latest in cosmetics testing processes, equipment and legislative requirements. Visitors will want to participate in the Expo’s Forums and Workshops, which will focus on how manufacturers must conduct safety assessments of new products under the European Union’s new Cosmetic Regulation, which was published in 2009 and comes fully into force in mid-2013.

The European cosmetics industry is working hard toward the final goal of the new legislation, which is that no cosmetic product containing an ingredient safety tested using animals, will be allowed for sale in Europe.

Cosmetics Test Expo 2012 will examine the industry’s progress in the development of alternative testing methods.

Friday, February 11, 2011

New laws for medical devices examined at Medical Device & Technology Expo 2011

The continually changing European Union regulations governing medical devices were the focus of two days of workshops offered by leading industry experts at the inaugural Medical Device & Technology Test Expo held in Cologne, Germany, this week.


Dr Rosy Eloy, Medical Director for Europe of BIOMATECH – NAMSA, focused on the changes to the new 2007/47 Medical Device Directive in her workshop.

As of March 2010, medical device manufacturers are required to beef up the evaluations of the safety and performance of their products. Dr Eloy underscored the new provision that manufacturers produce clinical data on the safety and performance of all medical devices, regardless of the classification of the device. Also new is the requirement that manufacturers back up their data with an analysis of the related risks and benefits.

Looking ahead, two workshops focused on how manufacturers of electronic medical devices can comply with changes to the regulations due to come into force from June 2012 in Europe and in Canada, and from June 2013 in the United States.


A team from Underwriters Laboratories (UL) led an interactive workshop on how manufacturers can get their products certified according to the 3rd edition of the IEC 60601-1, the internationally harmonized standard for the safety of electrical medical devices.

Dr Terenzio Facchinetti, UL’s Business Development Manager for Life & Health Sciences, said manufacturers could avoid the frustrations and cost of redesign of products if they consider the regulatory and certification requirements at the early stage of product development.


In a separate workshop, two experts from DEKRA Certification B.V. (formerly KEMA Quality), gave a practical demonstration on how manufacturers must incorporate risk analysis—a new provision in the law—into the safety testing of their products.

The workshops were a key feature of the Medical Device & Technology Test Expo 2011, the world’s first-ever business to business trade fair to focus exclusively on testing at each stage of product development. The three-day Medical Device & Technology Test Expo, held at Koelnmesse, closes today.

Check the Medical Device & Techology Test Expo website for pdf versions of the workshop and forum presentations: www.medicaldevicetestexpo.com. They will be made available by the end of February 2011.

Thursday, February 10, 2011

Medical Device & Technology Test Expo 2011

After much anticipation, the medical device testing community was given an event to remember at HuLST Expo 2011.
Walter+Bei enjoyed a productive show, with many interested visitors stopping by the stand

The inaugural Medical Device & Technology Test Expo offered many visitors their first chance to see a number of industry products, such as Mark-10’s Series 5 digital force gauge and the Falcon video measuring solution from Vision Engineering.

Mark 10's Series 5 digital force gauge.

Mark-10 believes the Series 5 gauge is perfect for a broad range of industries, including medical device. Available in capacities from 0.12lb to 500lb (0.5N to 2,500N) and boasting ±0.1% accuracy, the gauge is overload protected to 150% of capacity. An analog load bar tells users when such an overload is imminent.

Many visitors saw Vision Engineering's Falcon measurement machine for the first time

Falcon has been designed with 3-axis measurement of precision machined component parts in mind, according to its creator, Vision Engineering. The technology works with a touchscreen display that shows accurate measurement results in microns.

Medical Device & Technology Test Expo 2011 also played host to Bose Corporation’s ElectroForce Series 7 software, which works with the company’s range of test equipment. Operating on the Windows 7 platform, the software allows users to alter testing protocols, and change loading profiles based on specimen response.


Other product debuts came courtesy of Mecmesin, with the MultiTest-xt, and Lloyd Instruments, manufacturers of the LS1

The big news from the Lloyd Instruments stand was the breakthroughs being made in materials testing. Such advances have been made possible due to the LS1, a 1kN testing machine, that made its debut at the show. The LS1 features a wider crosshead speed range and improved measurement accuracy for evaluating the mechanical properties and performance of medical devices.


Visitors were keen to talk to industry heavyweights Instron and Marposs about their latest developments and products for the medical device market

Other stands of great interest were Instron’s, which featured a range of test equipment including the 5900 series and the latest ElectroPuls instruments and Marposs’, which featured the first public outing Orthoflex, the company’s latest optical vision system. Over at Mecmesin, all the talk was about MultiTest-xt, a touchscreen force measurement system that is specifically designed for conducting quality control assessments.

Away from the exhibition floor, there was a full program of presentations and workshops, giving audiences the chance to find out about industry developments and trends that could have an impact on the way they operate. Kicking off proceedings was Kathleen Johnson, president and founder of Medical Device Approvals, who talked about the implementation of FDA requirements into the new product design process.
There were also presentations from key organisations in the industry including Sterigenics, Intertek, SpineServ, LMS International and Underwriters Laboratories.

Pharma & Biotech Test Expo


One of the pharmaceutical industry's leading authorities on drug substances that could harm our DNA kicked off the workshops at the inaugural Pharma & Biotech Test Expo, now being held in Cologne, Germany.


Dr Andrew Teasdale, chair of AstraZeneca's Genotoxic Impurities Advisory Group, conducted the workshop, "Evaluating the risk of genotoxic impurities", at Koelnmesse on Tuesday, February 8, the opening day of the three-day Pharma & Biotech Test Expo 2011.

Drug manufacturers work continually to ensure their products are free of these toxins.

"Most if not all arise through the synthetic process used to manufacture drugs," said Dr Teasdale, whose groundbreaking book on the subject, Genotoxic Impurities: Strategies for Identification and Control, is due to be published later this month by Wiley.

Regulatory authorities' increasing concern with the potential presence of impurities that are genotoxic in drug products led to the publication of the European Medicines Authority guideline, effective from January 1, 2007, Dr Teasdale said.

The US Federal Drug Administration followed suit with a draft guideline, published in December 2008, but there remain many unanswered questions for regulators and industry.

"The biggest problem area we have is to get a common system," said Dr Teasdale, who gave the example of a drug AstraZeneca produced which the regulators of four different countries queried on 10 issues related to genotoxic impurities. Proof that there is no agreement among the regulators was evidenced by the fact that each highlighted a different area of concern, requiring the company to re-test the drug to answer each of the 10 queries. All tests came back negative, but the major headaches the company endured were unavoidable.

Industry and regulatory authorities will have to work together to achieve a common regulatory approach, he said, though progress is being made, particularly in Europe.

Dr Teasdale is actively involved in the work of the International Committee for Harmonisation to develop a common standard for testing of genotoxic impurities, a process that may take several years.

For the latest news on Pharma Test Expo 2011, visit the website: www.pharmatestexpo.com.


Note: Dr Teasdale's presentation at the Pharma Test Expo 2011 is available to download as a pdf file: 
http://www.hulst-expo.com/downloads/evaluating-gi-risk-pharm-test-expo-workshop.pdf (929kb).

Wednesday, February 9, 2011

Promising start to HuLST Expo

The human life science test community has gathered in Cologne to participate at the inaugural HuLST Expo, which is running in the German city from 8 to 10th February 2011.
Cologne played host to the inagural Hulst Expo

With more than 110 exhibiting companies covering four events – Medical Device & Technology Test Expo, Pharma Test Expo, Biotech Test Expo and Food & Beverage Test Expo – HuLST has been hailed as the only fully focussed exhibition that meets the specific needs of the human life science test industry.



HuLST Expo provided a great opportunity to meet potential future customers and suppliers

Featuring major industry names such as BOSE GmbH, PANalytical GmBH, HBM, PerkinElmer and Fraunhofer ITEM, HuLST Expo 2011 has proved popular with visitors and exhibitors alike. The show has provided an excellent platform for many products to be launched into the marketplace, such as the Series 5 digital force gauge from Mark-10, and the LS1 materials measurement system from Lloyd Instruments.

The forums held throughout the hall proved popular with delegates and exhibitors

Meanwhile, the latest industry developments have been be presented in the free-to-attend forums and workshops running alongside the main exhibition.



With more than 110 exhibitors, there was plenty of technology to be seen by visitors to HuLST Expo

David Stradling, marketing director at Total World Media, organisers of the show, was also satisfied with the first day. “We have seen plenty of activity on the stands, with exhibitors talking to potential and existing customers about doing business together,” he said.

Visitors came to Germany from Europe, North America and Asia.

“With two more days still to go, we believe that exhibitors will be delighted with the quality of visitors and leads that they depart Cologne with,” added Stradling.

For more information on the event, go to www.hulst-expo.com or contact John Challen at j.challen@hulst-expo.com

Wednesday, January 19, 2011

Food, Pharma, Medical Device Manufacturers to Meet for First Trade Fairs on Testing


Human Life Science Test (HuLST) Expo is inaugurating three trade fairs under one roof in Cologne, Germany, from February 8-10 — Medical Device & Technology Test Expo, Pharma Test Expo and Food & Beverage Test Expo
Dorking, Surrey – Only safe products are profitable and only testing can ensure product safety. With this in mind, HuLST Expo is launching the first-ever trade fairs dedicated to testing solutions for manufacturers of pharmaceuticals, medical devices and food and beverages.

Manufacturers, testing and quality assurance scientists and professionals will be meeting in Cologne, Germany, from February 8-10, to view the latest tools and processes the testing industry offers to ensure that products are safe at each stage of their development.

“HuLST Expo comes after two years of extensive work and follows the realisation that the ‘testing cat’ is permanently out of the bag as far as the manufacturer is concerned,” says David Stradling, HuLST Marketing Director. “We say this because industrialists no longer use their test programmes just for the sake of safe market passage but also as means of reassuring customers and end users of their commitment to product safety, quality and integrity. Today’s consumer has a greater sense of product testing than ever before, which gives manufacturers a psychological edge as it lends confidence and credibility to the end product.”

Visitors to HuLST Expo can address their testing requirements, no matter which sector they work in. A few examples follow:
  • Medical Device & Technology Test Expo will showcase diverse testing products and services, including materials durability testing instruments from BOSE GmbH, stent measurement devices from Heinz Schade, and the pre-clinical implant and materials testing from SpineServ GmbH.
  • Pharma Test Expo will offer the analytical instrumentation and solutions for physical and chemical characterization of pharmaceutical solids from PANalytical GmbH, and the texture, powder and flow analysers from Stable MicroSystems GmbH, to name only two exhibitors.
  • At Food & Beverage Test Expo, food safety and quality assurance professionals can find systems for odor, taste and visualization profiling from AlphaMOS, rapid testing methods for Salmonella from DSM Nutritional Products, and mass spectrometry instrumentation for the alcoholic beverages sector from Bruker Daltronic.
In addition to the exhibits, visitors can attend forums, workshops and keynote addresses examining the testing industry’s current issues and solutions. These presentations will run throughout the three days and their open format invites attendees to participate in the subjects that are most relevant to them. To view the current schedule of presentations, please view our web site at: http://www.hulst-expo.com.

Life science manufacturers interested in exhibiting at any of the three fairs should contact: Thomas Standley on + 44 1 306 803031, t.standley@hulst-expo.com.

Visitors can avoid the queues and pre-register for a FREE, three-day pass to both dedicated exhibition and speakers areas up until February 7. Entry on the day is Euro 35.

HuLST Expo 2011 is being staged for the first time to deliver a unique environment in which test and evaluation specialists from all three of the sectors covered by its umbrella events can meet and get to grips with testing and QA problems and solutions, and learn from the extensive programme of speaker forums and presentations.

For further information, please contact:

David Stradling
Marketing Director
HuLST EXPO
10 Dunley Hill Court
Ranmore
Dorking
Surrey
RH5 6SX
United Kingdom

direct tel: +44 (0)1306 803032
mobile: +44 (0)7702 889702
e-mail: d.stradling@hulst-expo.com
website: http://www.hulst-expo.com