In the ramp-up to the IQPC Cold Chain Management conference (Sept. 26-30; Philadelphia), several key industry announcements have come up:
-Envirotainer (Lagga Malma, Sweden) has finally obtained full FAA certification for its RKN e1 unit-load device (ULD), which has been in use since 2005 for shipping cold-chain products with active (powered) refrigeration/heating temperature control. The ULD had been hung up in technical difficulties between the European Air Safety Agency (EASA) and FAA; now, a bilateral agreement between the two has been signed. The clearance opens the door for US-flag air carriers to use Envirotainer ULDs in shipments originating in the US (previously, only non-US flag carriers could use the systems for flights landing in the US).
Envirotainer noted that it now has 725 RKN units in service, with 75 more to be added by year-end. And it is proceeding with manufacture and certification of its newest ULD, the RAP e2.
– DGP Intelsius (York, UK; US HQ: Indianapolis, IN) is partnering with American Thermal Instruments (Dayton, OH) to provide integrated temperature datalogging with Intelsius’ insulated containers. DGP Intelsius, which recently won economic-development-agency funding from Indiana to site its North American manufacuting there, brings container and insulation technology to the partnership; American Thermal brings its Log-IC datalogger, which employs RFID technology to communicate temperature data (and avoiding the need to open the container to retrieve the datalogger). The Log-IC technology is compliant with 21 CFR Part 11 requirements. The combination of insulated packaging and onboard temperature monitoring addresses the growing need to monitor drug and biological samples individually during shipping.
Visit with Pharmaceutical Commerce at the IQPC event to see, and talk about, the latest edition of the Biopharma Cold Chain Sourcebook.