Tag Archives: Clean Rooms

April 10, 2008 — /ARLINGTON HEIGHTS, IL/ — The Institute of Environmental Sciences and Technology will offer contamination control professionals the opportunity to enhance their skills while at the same time allowing for exposure to real-world experience during the tutorial “Swabbing Protocols for Cleaning Validation.” The tutorial will take place the morning of Tuesday, May 6, 2008 during the 54th Annual Technical Meeting and Exposition, ESTECH 2008, held May 4-7 at the Hilton Chicago/Indian Lakes Resort in Bloomingdale, IL.

The tutorial will feature hands-on demonstrations detailing proper swabbing techniques for high performance liquid chromatography (HPLC) and total organic carbon (TOC) for cleaning validation. Topics to be covered include proper methodology of sampling, review of cleaning validation challenges, and current industry practices. Participants will also learn about sampling materials requirements, swab material selection, vial handling, instrument loading, and how to improve recovery rates.

Registration and the ESTECH 2008 online advance program are available on the ESTECH web site.

Visit www.iest.org

April 10, 2008 — /HUDSON, WI/ — GEA Procomac, a GEA Group company specialized in aseptic filling technology for PET containers, has received a letter of non-objection from the United States Food & Drug Administration for aseptic filling systems for low acid shelf-stable products.

The non-objection letter was granted after FDA review of a master file submission based on the company’s aseptic line installation at Aseptic Solutions Inc., a company based in Corona, CA. The National Food Laboratory served as Procomac’s process authority for the master filing.

Procomac FDA-compliant aseptic filling technology for PET uses peracetic acid in liquid form to sterilize containers. Full recovery of sterilizing solution and rinsing water is built in the system to reduce consumption of chemicals.

Procomac has pioneered a number of aseptic technologies in the past ten years, including the use of a microbiological isolator technology instead of the traditional cleanroom environment for aseptic filling lines.

Procomac currently has installed 86 aseptic filling lines; 30 of them are capable of running low acid products, and 6 of these lines have been built to FDA standards in the United States.

GEA Niro Inc. is a full-service engineering company offering systems and solutions for liquid and powder processing. It is responsible for sales, service, and local project support and procurement for GEA Procomac in the United States.

Visit www.niroinc.com

April 10, 2008 — /PRNewswire/ — PRINCETON, NJ — Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company, today announced that it has entered into a cGMP contract manufacturing agreement with Alopexx Pharmaceuticals, LLC. According to the agreement, Laureate will produce Alopexx’s mAb F598 antibody under cGMP conditions. This antibody is planned for use in clinical trials and later for commercial production for the treatment and prevention of Staphylococcus aureus infections. Terms of the manufacturing agreement were not disclosed.

“We are pleased that Alopexx chose Laureate Pharma as their manufacturing partner,” says Robert J. Broeze, Ph. D., president and CEO of Laureate. “We will closely collaborate with the Alopexx team and help them drive their product from development into the clinic.”

“Laureate Pharma has a track record of demonstrated expertise in biopharmaceutical manufacturing, including capabilities in both clinical and commercial-grade materials,” says Dr. Daniel Vlock, president and CEO of Alopexx. “We look forward to our partnership with Laureate and advancing our antibody therapeutics program into the clinic.”

About Laureate Pharma, Inc.

Laureate Pharma is a full-service biopharmaceutical development and protein production company located in Princeton, NJ. Laureate Pharma offers superior bioprocessing services that accelerate new products from development through production. Laureate provides a wide range of specialized services from process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services, and regulatory support. Laureate is focused on two active segments of the biopharmaceutical industry: monoclonal antibodies and recombinant protein products. Laureate Pharma, Inc. is a wholly owned subsidiary of Safeguard Scientifics, Inc. (NYSE:SFE).

Visit www.laureatepharma.com

About Alopexx Pharmaceuticals, LLC

Alopexx Pharmaceuticals was founded to develop a promising new treatment for serious Staphylococcus aureus infections, including those caused by methicillin-resistant strains known as MRSA. In the past decade, MRSA has emerged as a major public health problem. Due to the increasing volume of antimicrobial usage around the world, MRSA and many bacteria have become increasingly resistant to most commonly used antibiotics. MAb F598 is a fully human monoclonal antibody that has the potential to serve as an alternative to antibiotics in the fight against MRSA and other S. aureus infections. Unlike antibiotics, monoclonal antibodies will not lead to the development of bacterial resistance. The target of the antibody is a carbohydrate on the bacterial capsule known as PNAG. PNAG has been found to be a critical factor in the virulence and immune response to MRSA as well as non-MRSA staphylococcal infections and is also expressed by other bacterial pathogens. Alopexx Pharmaceuticals, LLC was co-founded by Gerald Pier, PhD and Daniel Vlock, MD. Its aim is to develop and explore the use of novel therapies for the treatment and prevention of MRSA and other serious infections.

Visit www.alopexx.com

April 8, 2008 — /FDA/ — Grand Supercenter, Inc. of Lyndhurst, NJ is recalling the following product because it has the potential to be contaminated with Clostridium botulinum, a bacterium that can cause life-threatening illness or death.

HC Fresh Frozen Salted Croaker
Net. Wt.: 16.9 oz (480 g)
Item # HC 0500402
Expiration Date: Aug 02, 2009

Consumers are warned not to use this product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision, and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension, and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

HC Fresh Frozen Salted Croaker was distributed through H Mart stores including H Mart and Super H Mart in the New York, New Jersey, Pennsylvania, Illinois, and Texas area.

The potential for contamination was noted after routine inspection. No illnesses have been reported to date in connection with this problem.

Consumers who have purchased the HC Fresh Frozen Salted Croaker product are urged to return it to the place of purchase for a full refund. Consumers with questions may contact Grand Supercenter, Inc. at 201-507-9900.

Visit www.fda.gov

April 8, 2008 — /MINNEAPOLIS, MN/ — Malt-O-Meal announced today that it is voluntarily recalling its unsweetened puffed rice and unsweetened puffed wheat cereals produced with “Best if used by” codes between April 8, 2008 (coded as APR0808) and March 18, 2009 (coded as MAR1809) because they may have the potential to be contaminated with Salmonella.

The recalled product was distributed nationally marketed under the Malt-O-Meal brand and as some private label brands including Acme, America’s Choice, Food Club, Giant, Hannaford, Jewel, Laura Lynn, Pathmark, Shaw’s, ShopRite, Tops, and Weis Quality. A comprehensive listing of impacted products can be found here.

No illnesses have been reported to date in connection with this situation. All other Malt-O-Meal products are unaffected by this action and are safe for continued sale and consumption. The products affected by this recall represent less than one half of one percent of the company’s annual production of ready-to-eat cereal.

“Our first and highest priority is the safety of the consumers who use our products,” says Malt-O-Meal president and CEO Chris Neugent. “It’s important that we spread the word about this situation quickly and broadly in order to remove even the slightest possibility that someone will consume something harmful. We apologize for this situation and promise to do everything to complete the recall as quickly as possible.”

The recall was initiated after the company’s internal routine food safety testing detected the presence of Salmonella in a product produced on March 24, 2008. The company immediately commenced an investigation to determine the root cause of this one positive finding as well as the extent of any possible exposure. Initial results from this follow-up investigation indicate that additional product may have been exposed to this contaminant. Thus, out of an abundance of caution to protect consumers, the company has chosen to voluntarily remove all unsweetened puffed rice and unsweetened puffed wheat products that may have been contaminated.

Investigation into the source of the Salmonella has determined a root cause of this situation and corrective measures have been taken to ensure that there is no reoccurrence of this issue.

Persons infected with Salmonella may experience a variety of symptoms and illnesses. According to the U.S. Food and Drug Administration, persons infected with Salmonella may experience fever, diarrhea, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in more severe illnesses, some potentially life threatening.

Consumers who have purchased any products covered by this recall are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-877-665-9331. Information regarding this recall, including images of the Malt-O-Meal product packaging, also will be posted to the company’s website.

Visit www.malt-o-meal.com/recallinfo

April 7, 2008 — /PRNewswire/ — WALTHAM, MA — Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, announced that it has received U.S. Food and Drug Administration (FDA) clearance for SpectraTM MRSA, a test designed to screen for methicillin-resistant Staphylococcus aureus (MRSA), more commonly known as the “superbug.” With the highest positive predictive value commercially available for MRSA screening, Spectra provides accurate results within 24 hours. The Spectra MRSA test is manufactured, distributed, and sold under the Thermo Fisher specialty brand, Remel.

MRSA has become a major public health concern, with occurrences on the rise in healthcare facilities nationwide. According to a recent report by the Association for Professionals in Infection Control and Epidemiology (APIC), MRSA is prevalent in 46 of 1,000 patients in the U.S. — 8 to 11 times higher than previous estimates. Moreover, their findings suggest that MRSA, which is antibiotic-resistant and difficult to treat, may lead to as many as 119,000 patient deaths in U.S. hospitals annually.

In response to these findings, APIC issued a guide for the elimination of MRSA transmission in hospital settings. The guide includes comprehensive prevention measures, such as adherence to Centers for Disease Control and Prevention guidelines for hand hygiene, use of contact precautions, and targeted screening cultures.

“The need for more aggressive prevention measures to stop the spread of MRSA means that healthcare facilities are looking for cost-effective ways to test more patients, around the clock,” says Marijn E. Dekkers, president and chief executive officer of Thermo Fisher Scientific. “Spectra MRSA offers healthcare facilities a high-performance solution that integrates with routine laboratory workflows, enabling them to take a more proactive approach to patient care and safety.”

Spectra MRSA is a ready-to-use, labor-saving test easily adopted in any healthcare facility to enable continuous testing of patients. The test medium is easy to read, with MRSA appearing as distinctive dark blue colonies. Its use can help to simplify MRSA screening programs, allowing patient testing 24 hours a day, 7 days a week.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, enabling customers to make the world healthier, cleaner, and safer. With annual revenues of $10 billion, the company has more than 30,000 employees and serves over 350,000 customers within pharmaceutical and biotech companies; hospitals and clinical diagnostic labs; universities; research institutions; and government agencies, as well as environmental and industrial process control settings. Serving customers through two premier brands, Thermo Scientific and Fisher Scientific, the company helps solve analytical challenges from routine testing to complex research and discovery. Thermo Scientific offers customers a complete range of high-end analytical instruments as well as laboratory equipment, software, services, consumables, and reagents to enable integrated laboratory workflow solutions. Fisher Scientific provides a complete portfolio of laboratory equipment, chemicals, supplies, and services used in healthcare, scientific research, safety, and education.

Visit www.thermofisher.com

April 7, 2008 — /PRNewswire/ — VIENNA, AUSTRIA — Vela Laboratories announced today that it has received the GMP certificate for its analytical and quality control laboratories. “Good Manufacturing Practice” is a body of internationally accepted regulations set forth by European and American drug agencies. GMP compliance ensures that pharmaceuticals, active ingredients, and medical devices are produced and quality-controlled according to state-of-the-art standards.

“GMP compliance is the gold standard in quality assurance in the life science industry. It is a major achievement for Vela Labs to have reached the GMP certification just 18 months since its formation,” says Dr. Markus Fido, founder and CEO of Vela Laboratories. “Now that Vela Laboratories is GMP certified, its analytical services fully qualify to support clinical studies as well as regulatory submissions.”

“GMP certification is an important milestone for our analytical services business. Now we will start to consistently expand our analytical methods portfolio that we are offering to the pharmaceutical and biotech industry,” says Dr. Andreas Nechansky, founder and chief operating officer of Vela Laboratories.

“Having achieved GMP compliance enables Vela to develop its therapeutic anti-cancer antibodies in the shortest time possible and with the highest quality,” says Dr. Ralf Kircheis, founder and chief scientific officer of Vela Laboratories.

About Vela Laboratories

Vela Laboratories (Vela pharmazeutische Entwicklung und LaboranalytikGmbH) provides a broad portfolio of analytical methods for preclinical and clinical development including studies in support of regulatory submissions and product release for biopharmaceuticals. Additionally, the company develops innovative immunotherapeutics for the treatment of cancer, including therapeutic antibodies and multi-epitope vaccines. The company’s lead product, a humanized monoclonal antibody against a common tumor antigen, is in clinical development. In addition, it also has development programs underway that aim at improving the efficacy and tolerability of therapeutic antibodies through targeted changes to the sugar structure of the antibody molecules.The Company, headquartered in Vienna, Austria, was founded in November 2006. Vela Laboratories is funded by private investors, grants from Austrian government agencies (AWS and ZIT/LISA), and through revenues generated by its analytical services business.

Visit www.vela-labs.at

April 7, 2008 — /PRNewswire/ — SHANGHAI, CHINA — STMicroelectronics (NYSE:STM), one of the world’s leading semiconductor companies, today announced the inauguration of its new headquarters for Greater China (China, Hong Kong, and Taiwan). Located in the Zizhu Science Park in the Minhang District of Shanghai, the new building was officially inaugurated by Alain Dutheil, COO of ST, and Bob Krysiak, corporate VP and general manager, Greater China region, in the presence of Shanghai government officials, Massimo Roscigno, Consulate General of Italy, and Jacques Torregrossa, Consulat General de France.

ST’s new Greater China HQ reflects not only the company’s current status as one of the top five semiconductor suppliers in the Chinese market, but also its determination to further increase its presence in one of the world’s most important regions. While the new HQ houses all regional business activities, its main focus will be on research and development, creating innovative new solutions for ST customers both in the Greater China region and around the world. The size of the building, some 20,000 square meters, allows for growth of ST staff in Shanghai, from nearly 400 today to a maximum capacity of 1,200.

“Greater China already accounts for nearly 30 percent of our worldwide sales, but is set to play an even greater part in our future growth. We are already an enthusiastic and committed part of the local ecosystem, thanks to the energy and creativity of the hundreds of local engineers we currently employ, and we plan to recruit many hundreds more over the next few years,” says Bob Krysiak, ST corporate vice president and general manager, Greater China Region. “The Shanghai R&D team will be seamlessly integrated into ST’s renowned worldwide R&D organization, so that engineers in Shanghai will be working with, and contributing to, state-of-the-art technologies and solutions of global importance,” notes Krysiak.

Currently, around half of ST’s employees in the region are engineers, either supporting local customers in developing innovative new products across the spectrum of electronics applications, or working in competence centers, where silicon designers and applications engineers work together to develop solutions for partners and customers around the world. ST already has two competence centers in Shanghai, one focusing on digital TV software for worldwide platforms and the other dedicated to multi-segment applications. To date, ST’s Greater China silicon design team has developed more than 60 products for both local and worldwide customers.

“Since we set up our first office in Beijing as far back as 1984, ST has continually increased its commitment to the region, which is illustrated not only by the new HQ and R&D center in Shanghai, but also by our second assembly and test facility that we are building in Shenzhen, and by the important research projects we are carrying out with leading Chinese universities and institutions,” says Alain Dutheil, chief operating officer, STMicroelectronics. “We are proud of the success we have already achieved in China and excited by the contribution we can make to the continued growth of China’s IT industry by innovating in China for China.”

The new Greater China HQ is built to high environmental standards and aims to provide the best working environment for the staff. For example, it features a long, narrow floor plan that maximizes the level of natural lighting, providing a better working experience while saving energy. There will also be wellbeing facilities on-site, including a gym and basketball field. The building also includes a demo room where applications developed by ST’s Greater China IC design center and competence center are exhibited. These applications include solutions for eBike for developing countries, robots, “green” air conditioning equipment, a variety of advanced home entertainment solutions, and a demonstration car displaying the most advanced solutions for security, power train, in car entertainment, and navigation.

About STMicroelectronics

STMicroelectronics is a global leader in developing and delivering semiconductor solutions across the spectrum of microelectronics applications. A combination of silicon and system expertise, manufacturing strength, intellectual property portfolio, and strategic partners positions the company at the forefront of system-on-chiptechnology, and its products play a key role in enabling today’s convergence markets. The company’s shares are traded on the New York Stock Exchange, on Euronext Paris, and on the Milan Stock Exchange. In 2007, the company’s net revenues were $10 billion.

Visit www.st.com

April 7, 2008 — /PRNewswire/ — SARASOTA, FL — Sunovia Energy Technologies, Inc. (BULLETIN BOARD: SUNV) and EPIR Technologies, Inc. (EPIR) announce the development of new solar cell materials that Sunovia and EPIR believe will rival the most efficient multi-junction solar cell performance in existence today at significantly less cost. The companies’ plan to accomplish this by uniquely combining the most prevalent photovoltaic semiconductors in the market today, cadmium telluride (CdTe) and silicon (Si), into a breakthrough multi-junction solar cell that leverages the economies of scale and manufacturing infrastructure that is associated with these materials. The enabling high-throughput manufacturing technologies for growing CdTe on Si have been proven by the University of Illinois at Chicago and successfully transferred by EPIR into night vision sensors over the past decade. Today, the technologies that have enabled the commercialization of night vision sensors and military superiority through “Owning the Night” are now being used to accelerate the development of next-generation, multi-junction solar cell materials that position Sunovia and EPIR for “Owning the Daylight” in the future.

These breakthrough materials, which have been proven within night vision infrared systems for many years, will initially be applied to concentrator PV systems with dramatically reduced price points from what is available today. The companies believe this will enable solar based electricity generation at prices equal to, and even lower than, current grid supplied power from non-renewable sources. CPV systems use optics and tracking mechanisms to concentrate the sun’s rays into a smaller area, therefore requiring less solar cell material for the same amount of electricity as compared to a traditional flat-plate solar panel that does not use concentrator optics. As the deposition processes are further refined and increased in throughput, low cost high-efficiency solar cells for specialty and terrestrial applications using flat-plate systems, as opposed to CPV systems, will be commercialized. In the future, new materials and technologies will be applied in ultra-high volume deposition processes to create thin films on flexible substrates for residential, commercial, and utility power generation products with very high production capacities and high velocity time-to-market deployments. The companies anticipate that revenues from IR materials will begin in 2008 with revenues from advanced CPV materials following after the IR technology is transferred to EPIR’s next-generation solar cell manufacturing facilities, currently in development.

Until now, semiconductors for PV applications have essentially come in two forms: high-efficiency, high cost solar cells created from multi-junction III-V semiconductors, and lower cost solar cells made from crystalline silicon and amorphous thin films. While II-VI solar cell materials such as CdTe have shown promise, the lack of suitable low cost substrates on which to deposit high quality single crystal thin films have relegated these very efficient materials to polycrystalline films having low-efficiency on heavy glass substrates. In contrast to the approximate 16 percent efficiency attained under the best conditions (and less than 10 percent efficiency in real world modules) at different laboratories for amorphous or polycrystalline CdTe solar cells, the EPIR calculations for single crystal CdTe solar cells gave an efficiency of 24 percent using realistic assumptions and numbers characteristic of CdTe of typical crystal quality for material grown on silicon by high throughput molecular beam epitaxy (MBE) deposition methods developed by EPIR. This efficiency was calculated assuming no antireflection coating and no back mirroring under a one sun intensity with a terrestrial solar spectrum and with the standard global tilt of 37 degrees (AM1.5G). The calculation was performed for a cell having a thin top layer of n-type CdS on 4 µm of p-type CdTe, the most common CdTe solar cell configuration.

For a CdTe solar cell of a proprietary design, EPIR calculated an efficiency that is above 26 percent. The company believes a maximum efficiency above 30 percent is achievable for optimized two-junction CdTe/Si solar cells in which both the CdTe and the Si act as solar energy absorbers. The results of these detailed calculations indicate that the upper limits of energy conversion efficiencies of solar cells employing group II-VI semiconductors, such as CdTe, rival those of present solar cells using the corresponding group III-V semiconductors, such as gallium arsenide (GaAs), with much greater manufacturability and at significantly lower cost.

The companies believe the above results indicate that the CdTe/Si, and more generally II-VI based technology, has the potential to displace the high cost III-V based technology, particularly in CPV systems for power plants. The results also indicate that technologies based on EPIR’s novel high throughput MBE deposition technique for growing epitaxial crystalline CdTe or CdTe/Si should displace the current amorphous or polycrystalline CdTe cells and Si cells, respectively.

Dr. J. Garland of EPIR Technologies, formerly professor of physics at the University of Illinois, states that “As an environmentalist, I am really excited by these results and by the rapid progress EPIR is making toward the manufacture of II-VI based solar cells. Renewable energy sources such as solar energy must be used to preserve the earth for future generations and for our national security. Solar power needs only a reduction in cost to turn the corner and become a primary source of energy here and around the world, and I believe that the EPIR II-VI technology can provide the necessary cost reduction.”

Sunovia and EPIR have exclusively partnered to commercialize solar and IR technologies for the renewable energy and night vision markets. Sunovia is the exclusive marketer of all products, technologies, and intellectual properties that are developed by EPIR, and currently owns a significant equity interest in EPIR. EPIR is the world leader in R&D on II-VI materials and devices for IR detection and imaging for night vision, missile tracking, exploration in space, and other applications. The manufacturability of II-VI based IR focal plane arrays for IR imaging shows that II-VI materials grown by MBE have reached a maturity level worthy of solar cell production. Furthermore, the company has now completed a major facility for the manufacture of CdTe on silicon and for the development of improved solar cells based on II-VI materials.

About Sunovia Energy Technologies, Inc.

Sunovia is a Sarasota, FL-based renewable energy and energy conservation company that is working to develop one of the most advanced and cost-effective cadmium telluride solar cell technologies ever created. Sunovia is also the owner of the proprietary EvoLuciaTM LED lighting product line. The energy-efficient solid-state lighting solutions have received CE, FCC, TUV, and IP23 regulatory approval and are now being marketed worldwide.Sunovia owns a significant equity interest in Illinois-based EPIR Technologies, Inc. Sunovia and EPIR have a network of close collaborative relationships with the major Defense Department and industrial labs involved in IR detection and imaging, including the Army Research Laboratory, the Night Vision Electronic Sensors Directorate, BAE Systems, Lockheed Martin, DRS, Raytheon, Rockwell, Texas Instruments, and other laboratories around the world.

Visit www.sunoviaenergy.com

About EPIR Technologies, Inc.

EPIR Technologies, Inc. is one of the most advanced infrared sensor and imaging companies in the world. EPIR’s knowledge, experience, and expertise in the growth of CdTe, HgCdTe, and other II-VI semiconductors equals that of any other company in the world. It’s prowess in this area is unmatched and has been endorsed by the award of unprecedented congressional funds for the development of a manufacturing capability for CdTe on Si and the award of a patent for growing CdTe directly on a Si readout integrated circuit.

Visit www.epir.com