Tag Archives: Clean Rooms

JULY 7, 2009 — SILVER SPRING, MD — Michael R. Taylor, J.D., a nationally recognized food safety expert and research professor at George Washington University’s School of Public Health and Health Services, will return to the U.S. Food and Drug Administration to serve as senior advisor to the commissioner.

“I am pleased to welcome Mike Taylor back to the FDA,” Commissioner of Food and Drugs Margaret A. Hamburg, M.D., said in announcing Taylor’s appointment. “His expertise and leadership on food safety issues will help the agency to develop and implement the prevention based strategy we need to ensure the safety of the food we eat.”

Commissioner Hamburg said that Taylor would work closely and collaboratively with her office and with the management of the FDA’s Center for Food Safety and Applied Nutrition, Center for Veterinary Medicine, the Office of Regulatory Affairs, Congress, and with members of the Obama Administration.

Specifically, Taylor will work to:

Assess current food program challenges and opportunities
Identify capacity needs and regulatory priorities
Develop plans for allocating fiscal year 2010 resources
Develop the FDA’s budget request for fiscal year 2011
Plan implementation of new food safety legislation.

“I am honored and grateful that Commissioner Hamburg has asked me to return to the FDA in the position of Senior Advisor to the Commissioner,” Taylor said. “I am looking forward to working with her, Principal Deputy Commissioner Joshua Sharfstein, and all of the FDA’s dedicated and talented people.”

Taylor has had a long and distinguished career in public service. He began at the FDA in 1976 as a litigating attorney. He served as the FDA’s Deputy Commissioner for Policy from 1991 to 1994, overseeing FDA’s policy development and rulemaking, including the implementation of the Nutrition Labeling and Education Act and issuance of new seafood safety rules.

From 1994 to 1996, he served at the U.S. Department of Agriculture as Administrator of the Food Safety and Inspection Service (FSIS) and Acting Under Secretary for Food Safety. During that time, he spearheaded public health-oriented reform of the FSIS. Since 2000, Taylor has worked in academic and research settings on the challenges facing the nation’s food safety system and ways to address them.

Taylor’s recent research agenda has focused on policy, resource, and institutional issues that affect the success of public health agencies in carrying out their prevention-related missions. He served as chair of the steering committee of the Food Safety Research Consortium, collaboration among six universities and a nonprofit think tank to improve food safety decision making and priority setting.

JUNE 11, 2009 — ARLINGTON HEIGHTS, IL — The Institute of Environmental Sciences and Technology (IEST) has created a new category of membership for recent graduates entering the environmental sciences profession. A significantly discounted membership is available to anyone who has graduated from an accredited technical college or university undergraduate program within the last two years.

IEST’s Young Professionals Membership offers a wealth of educational and networking benefits, including:

* An understanding of the latest technology and research through a subscription to the peer-reviewed technical online Journal of the IEST.

* The ability to attend educational courses and conferences at a discounted member price.

* Access to the latest industry standards and recommended practices at a discounted member price.

* The IEST Membership Directory, for networking with industry professionals.

* The IEST JobBoard, where young professionals can search for job and internship openings, post their resumes or advertise job openings at their companies.

* Opportunities to receive individual recognition and technical awards.

* The chance to participate in IEST Working Groups or Chapters.

IEST is an international not-for-profit technical society of engineers, scientists, and educators that serves its members and the industries they represent (simulating, testing, controlling, and teaching the environments of earth and space) through education and the development of recommended practices and standards. IEST is an ANSI-accredited standards-developing organization, and is especially involved in evolving standards for cleanrooms and nanotechnologies.

More information about IEST can be found at www.iest.org. To apply for a Young Professionals Membership, see the “How to Join” page.

JUNE 11, 2009 — NORTHFIELD, IL — Thanks to the pharmaceutical industry and to general activity in Asia, the market for cleanroom consumables will grow one percent next year and reach sales of $6.6 billion. This is the latest forecast published by research firm, The McIlvaine Company (www.mcilvainecompany.com), in its “World Cleanroom Markets” report.

Among some of the trends cited in the latest report, single use garment sales will be slightly less than reusables in 2010. But, the rental revenues for reusables reflecting both the garment sales and the processing (laundering) will generate three times the revenues of the single use garments.

The issue of greenhouse gas emissions related to single use garments could act as a deterrent for this selection, but a new study by McIlvaine shows that the total environmental burden including the water contamination incurred in washing reusable garments is similar for both single use and reusables.

Cleanroom hardware sales in 2010 are pegged at $4.7 billion. Hardware revenues are more volatile than consumables. There was substantial shrinkage in flat panel and semiconductor revenues in the last 18 months, but a slow recovery will result in modest growth in 2010. The pharmaceutical segment will experience 2 percent growth in 2009 and a likely 7 percent growth in 2010.

Asia will continue to set the pace in the cleanroom market. This region will account for 60 percent of the cleanroom hardware sales in 2010 and 61 percent of the cleanroom consumables. Taiwan, South Korea and Japan will continue to play a big role, but China is the fastest growing cleanroom market in the region.

Europe has experienced the greatest shrinkage over recent years and will account for only 14 percent of cleanroom consumables in 2010. The Irish cleanroom market has been particularly hard hit in the recent downturn.

European hardware and consumables suppliers have, however, internationalized and, therefore, offset the shrinking home market with overseas sales. Camfil is a good example of this internationalization. merican companies such as Lydall, Donaldson, Filtration Group, Hollingsworth & Vose, W.L Gore, and American Air Filter have Asian manufacturing facilities and are competing successfully in the local Asian Markets. In the case of American Air Filter, there is even an Asian owner of the company.

For more information on World Cleanroom Markets, go to: http://www.mcilvainecompany.com/brochures/cleanroom.html

JUNE 11, 2009 — ROCKAWAY, NJ — Biotest Diagnostics Corporation will take part in hosting the 2009 Environmental Monitoring Conference being held on June 18, 2009 in United Therapeutics Corporation’s Research & Development Facility in North Carolina’s Research Triangle Park (RTP). The Conference is free and targets quality assurance professionals within North Carolina’s Research Triangle Park. The full-day conference program will include such current pertinent topics as “Microbial Contamination and Control” and “Selection of Agar Media in an Environmental Monitoring Program.” More information about the conference and the complete agenda can be obtained at www.BiotestUSA.com/micro

JUNE 11, 2009 — AGAWAM, MA — Validation requirements and combination products pose a unique set of challenges to the medical device engineer. A new whitepaper from Microtest Laboratories discusses how an engineer can best utilize packaging validation programs and discusses options when testing medical device packaging.

FDA concerns regarding terminally sterilized medical products are based on years of data that implicates failures in primary packaging. The majority of failures occur because of inadequate package validation programs.

The white paper, “Package Validation Requirements For Medical Devices and Combinatory Products,” by Stephen Richter, Ph.D, RAC, SM(NRM), President and Chief Scientific Officer of Microtest Laboratories, provides insight into general requirements in microbiological and physical testing programs. It also discusses how combination products pose a unique set of challenges to the package validation

Specifically, the white paper discusses how medical device stability package validation programs should be designed to encompass overt product storage and shipment conditions and that performing accelerated aging studies does little to address liability during shipment and storage.

To download the white paper, “Package Validation Requirements For Medical Devices and Combinatory Products” visit: http://www.microtestlabs.com/package-validation-paper/

About Microtest

Microtest is a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

JUNE 11, 2009 — FRANKFURT, GERMANY — Where do organic and printed electronics stand? Which applications will be launched over the next several years? Which production processes and materials are needed? Which technological hurdles need to be overcome? Answers to these and other questions can be found in the new, expanded version of the “OE-A Roadmap” for organic and printed electronics. The Roadmap, as well as numerous new demonstrators, will be introduced by the OE-A for the first time at the Large-area, Organic and Printed Electronics Convention (LOPE-C) which will take place June 23rd through the 25th, 2009 in Frankfurt, Germany.

Initial products based on organic electronics — thin, light-weight, flexible, and inexpensive to produce — are already on the market. The Organic Electronics Association – OE-A, the leading international industry association for organic and printed electronics, supports its members and this emerging field by providing an information platform, initiating technical cooperation and by keeping the public informed about this new technology.

‘Organic electronics you can touch’ is made possible by the new OE-A brochure. Every copy includes a set of functional organic electronic components as a give-away, such as various printed displays, RFID-tags, switches, batteries and transistor structures. Furthermore, six additional demonstrators in which a number of components are combined on flexible plastic- and paper substrates will be introduced at LOPE-C.

The following OE-A members collaborated on these projects: Acreo, Agfa, CEA, COPACO, DuPont Teijin Films, Felix Schoeller, Fraunhofer IAP, FUJIFILM Dimatix, GSI Technologies, H.C. Starck Clevios, HDM-Stuttgart, ITRI, Leonhard Kurz Stiftung, Mitsubishi Polyester Film, M-Solv, NTERA, Plextronics, PolyIC, Schreiner Group and VARTA Microbattery.

The updated and expanded third edition of the OE-A Roadmap for organic and printed electronics offers an overview of future product generations as well as requirements for materials and technologies. Fundamental challenges on the path to mass production – “Red Brick Walls” – have also been identified.

“The Roadmap and the technical projects are central themes of the OE-A, and a constantly expanding group of companies from Europe, North America and Asia collaborate intensively on these topics. Since LOPE-C is the internationally leading conference and exhibition, it is the perfect venue for unveiling these results.” says Wolfgang Mildner, Managing Director, PolyIC and Chairman of the Board of the OE-A.

The latest results of the OE-A will be presented in a keynote address, at the exhibition as well as during a press conference at LOPE-C.

About the Organic Electronics Association (OE-A):
The Organic Electronics Association (OE-A) is a working group within the German Engineering Federation (VDMA) and was founded in December 2004. The OE-A is the leading international industry association for organic and printed electronics and represents the entire value chain of this emerging industry. Our members are world-class global companies and institutions, ranging from R&D institutes, component and material suppliers to producers and end-users. More than 120 companies from Europe, North America and Asia are working together to promote the establishment of a competitive production infrastructure for organic electronics. The vision of the OE-A is to build a bridge between science, technology and application. More than 3,000 member companies from the engineering industry make VDMA the largest industry association in Europe.
For more information, visit www.oe-a.org.

About the Large-area, Organic and Printed Electronics Convention (LOPE-C 2009):
LOPE-C – the Large-area, Organic & Printed Electronics Convention – is a conference with an accompanying exhibition at the Convention Center, Messe Frankfurt, Germany, that will take place June 23-25, 2009. LOPE-C is the premier international marketplace for organic and printed electronics and will be hosted by the OE-A in cooperation with Messe Frankfurt Austellungen GmbH. In more than 100 presentations by global experts from business and research, the latest developments, trends, and applications in the field of organic and printed electronics will be introduced. Products, prototypes, machinery and services relating to organic and printed electronics will be presented by 50 companies and institutes from all around the world at the accompanying exhibition.
For more information, visit www.lope-c.com.

For questions, please do not hesitate to contact Dr. Klaus Hecker (Tel.: +49 69-6603-1336, [email protected]).