CEIV Pharma certification; expanded temperature regimes and better calibration capabilities
Capability extensions ranging from better temperature calibration to expanded temperature-maintenance regimes were in the news in the past few weeks. The developments demonstrate a continuing maturation of the life sciences cold chain arena. For example:
● Delta Cargo won CEIV Pharma certification from the International Air Transport Assn. in July, encompassing headquarters operations and its Atlanta cargo hub. The Center for Excellence for Independent Validators (CEIV) certification is a program administered by IATA to cover not only air cargo activities but also storage and ground transportation. While it is not a regulatory requirement of national health agencies, it does put certified vendors in a better position to attract life sciences clients. Delta also announced that it can now carry the Envirotainer rap 2 active (powered) cargo container on its aircraft, in addition to units from CSafe, va-Q-tec and other Envirotainer units.
● Cryoport, which has been expanding its shipping container lines and logistics services for cryogenic delivery of life sciences products, has added a 2-8°C container line, giving it what it claims as “the entire logistics continuum for regenerative medicine clinical and commercial programs.” The 2-8° line, branded as “C3,” employs Credo containers from Pelican Biothermal, modified with Cryoport’s monitoring and communications equipment.
● Carrier TransiCold, a unit of United Technologies Climate, Controls & Security, has announced new calibration functions in its PrimeLine unit, which is a self-contained refrigeration unit mounted onto ocean-going containers. Carrier notes that the calibration functions are specifically capable of meeting good distribution practices (GDPs) of life sciences products. “Adding calibration functionality to the refrigeration unit means temperature control sensors may now be calibrated in accordance with pharmaceutical shipper specifications, typically every six months or annually,” said Suresh Duraisamy, senior product manager, in a statement. The company also contends that “Producers of pharmaceuticals that require temperature control are increasingly turning to container shipping as a lower cost alternative to airfreight.”
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