CSafe Confirms Operational Qualification of the AcuTemp RKN Air Cargo Container by Major Pharmaceutical Companies

By Csafe Llc, PRNE
Tuesday, January 5, 2010

AcuTemp RKN Proven Successful for the Transport of Temperature Sensitive Cargo

DAYTON, Ohio, January 6 - 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 degrees C to 8 degrees 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.

Linda Raisch, +1-937-312-0114, lraisch at csafellc.com

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