Compliance with Good Distribution Practice (GDP) guidelines for transport of pharmaceutical and biomedical products is improved with Carrier Transicold’s new temperature sensor calibration capability for its PrimeLINE container refrigeration units.
Effective immediately, the calibration function will be included in software loaded into every new PrimeLINE unit, including those with energy-saving EDGE technology. The calibration update involves both the Micro-Link 3 controller software and DataLINE software, which provides functionality related to unit data retrieval. Carrier Transicold-authorized service providers can also upgrade PrimeLINE units already in service with the latest software—Micro-Link 3 controller software, version 5368; and DataLINE software, version 3.1.
“European Commission GDP guidelines, which are used worldwide, call for the equipment to control or monitor environments where medicinal products are stored and transported to be calibrated at defined intervals, including recordkeeping of calibration activities,” said Suresh Duraisamy, senior product manager, global container refrigeration, Carrier Transicold. “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.”
Producers of pharmaceuticals that require temperature control are increasingly turning to container shipping as a lower-cost alternative to airfreight. With sensor calibration done to help assure proper maintenance of critical temperatures in accordance with GDP, the PrimeLINE unit’s built-in data recorder is suitable for monitoring and recording temperature performance of the refrigeration system for GDP purposes.
In practice, service technicians will use the new software to check and automatically calibrate the refrigeration unit’s two supply-air and return-air temperature sensors. Calibration can be done by shipping line service depots or through Carrier Transicold-authorized service providers.
A future software revision will add the calibration capability for Carrier Transicold’s natural refrigerant NaturaLINE units.
For more information, go to www.carrier.com/container.