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Pharma Capsules
Brief pharmaceutical news items for January 2008.

Pharmaceutical Technology
Volume 32, Issue 1

Certifications
FAA Certifies AcuTemp Container


The "RKN" refrigeration container from AcuTemp.
AcuTemp Thermal Systems (Dayton, OH), a leading designer and manufacturer of high-performance insulation and temperature-sensitive packaging, announced that its "RKN" temperature-controlled air-cargo container received Federal Aviation Administration (FAA) approval. FAA granted the approval to AmSafe Bridport (Phoenix, AZ), AcuTemp's partner in the certification process. AcuTemp says the approval marks the first instance that FAA has certified a compressor-driven refrigeration unit, thus permitting its use in the cargo section of an aircraft. The container was designed to allow the air-cargo industry to transport and precisely manage temperatures of perishable items such as vaccines, pharmaceuticals, and reagents.

Vetter Is Certified to Work in Japan

Japan's Ministry for Health, Labor and Welfare gave Vetter Pharma-Fertigung (Ravensburg, Germany) accreditation as a foreign manufacturer for the Japanese pharmaceutical market. Vetter provides aseptic filling of prefilled injection systems. The company was certified in the "drug, sterile product;" "drug, packaging, labeling, and storage;" and "medical device, sterilized medical device" categories.

Expansions
Microfluidics Launches New Website

Microfluidics (Newton, MA) launched its newly redesigned website. The site ( http://www.microfluidicscorp.com/) provides clients an in-depth view of the company and its products using an intuitive navigation system and multimedia content. Visitors can view company news, upcoming events, press releases, newsletters, and industry-specific solutions. The items are organized into categories such as pharmaceutical, biotechnology, and chemical. Visitors also can search for information about topics such as cell disruption, high-shear particle-size reduction, liposomes, emulsions, and carbon nanotubes.

DRAXIS Builds New Facility

DRAXIS Health (Montreal, Canada) began constructing a 77,000-ft2 new secondary-packaging and warehousing facility in St-Anne-de-Bellevue, Quebec. The facility will help DRAXIS produce multiple nonsterile specialty semisolid products for Johnson & Johnson Consumer Companies (Skillman, NJ). The new building is expected to be completed by mid-2008. DRAXIS then will install and validate the facility's equipment and ensure the facility complies with the applicable regulatory requirements.

Advion BioServices Acquires New Instruments

Advion BioServices (Ithaca, NY) the bioanalytical services division of Advion BioSciences, is expanding its capacity with the recent acquisition of two Applied Biosystems–MDS Sciex "API 5000" mass spectrometers and Waters "Acquity" ultraperformance liquid chromatography (UPLC) capability. In addition, the company hired 17 employees after moving to its new laboratory facility in April 2007.

Advion has operated a bioanalytical liquid chromatography–mass spectrometry laboratory since 1993 to serve the pharmaceutical industry. The addition of the new API 5000 mass spectrometers gives Advion's bioanalytical laboratory a total of 24 triple-quadrupole mass spectrometers, thus making it one of the largest bioanalytical contract laboratories in the world. Advion's acquisition of UPLC broadens the range of liquid-chromatography capabilities the company can offer its customers.


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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
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