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Release ID: 4472

CSAFE CONFIRMS OPERATIONAL QUALIFICATION OF THE ACUTEMP RKN AIR CARGO CONTAINER BY MAJOR PHARMACEUTICALCOMPANIES

AcuTemp RKN Proven Successful for the Transport of Temperature Sensitive Cargo

DAYTON, OHIO January 5, 2010 – CSafe, LLC, www.csafellc.com, provider of active container solutions for the temperature sensitive airfreight market, confirmed the successful Operational Qualification (OQ) of its AcuTemp RKN by three major pharmaceutical companies. Each company performed extensive and independent testing of containers at a wide range of temperature requirements across multiple shipping lanes, ambient conditions, varying payload sizes, and shipment durations. The consistent and successful results of the testing process by all three companies identify the AcuTemp RKN as a Qualified and reliable solution for transporting temperature sensitive healthcare products globally, particularly at 2°C to 8°C and especially where extreme ambient temperatures are encountered.

The AcuTemp RKN air cargo container is designed to eliminate the challenges associated with maintaining the cold chain for shipping temperature sensitive pharmaceuticals and biotechnology products. These products are often highly susceptible to damage or compromise due to insufficient temperature management as a result of inadequate packaging for the encountered ambient temperature conditions, dry ice irregularities, and transit delays. CSafe addresses all of these issues with its AcuTemp RKN which provides superior thermal efficiency, compressor-driven technology, and qualified operating capabilities for extended periods.

The Operational Qualification process employed for qualifying an active cooling and heating container along with the performance merits of the AcuTemp RKN were highlighted at IQPC’s 7th Cold Chain Distribution for Pharmaceuticals conference where pharmaceutical industry professional Geoffrey Glauser, Director Global Packaging Technology for Pfizer, presented an OQ test approach for active containers. As reported by Mr. Glauser, the AcuTemp RKN by CSafe maintained “exceptionally stable interior payload temperatures” when exposed to high and low ambient temperature extremes. Test results for summer and winter temperature profiles concluded the unit as “accepted for global shipping of drug substance and drug product with minimum and maximum mass/volume.”

“We are happy to report that the day-to-day working performance of the AcuTemp RKN accurately mirrors the performance and reliability testing performed by several large pharmaceutical and biotechnology companies,” states Oliver Bootz, vice president of business development for CSafe. “Not only have our customers experienced the superior performance of our active RKN versus dry ice or other compressor driven containers, its approval by both the Federal Aviation Administration (FAA) and the European Aviation Safety Agency (EASA) provides for the widest availability of global shipping lanes,” says Bootz.

Since it began service in 2008, the AcuTemp RKN is now in use by over 40 pharmaceutical companies and has consistently demonstrated its ability to maintain a customer-desired payload set-point, resulting in no recorded product loss. The container’s heating and compressor driven cooling capabilities eliminate the cost and environmental challenges associated with the use of dry ice, refrigerated trucking and internal packaging.

About CSafe, LLC

CSafe, LLC provides technology solutions for the temperature-sensitive air freight market. Its flagship product, the AcuTemp RKN, is the first and only active unit of its kind with both FAA and EASA approvals. CSafe has a worldwide network of logistics partners to address the stringent requirements of the temperature sensitive air cargo market. Headquartered near Dayton, Ohio, CSafe, LLC is a joint venture between AmSafe, Inc. and AcuTemp Thermal Systems, with locations in Washington State and Ohio and service center partners worldwide. For more information, visit www.csafellc.com.

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