New Solution for Temperature-sensitive Shipments

FedEx Custom Critical addressing compliance requirements, increased handling concerns with new service

FedEx Custom Critical addressing compliance requirements, increased handling concerns with new service

Akron, OH — February 5, 2004 — FedEx's Custom Critical division has launched a new service to offer a validated solution for temperature-sensitive shipments, addressing compliance requirements and increasing concerns about the proper handling of temperature-sensitive materials.

Custom Critical, which stakes a claim as North America's largest provider of expedited time-critical shipments, said its new shipping option, dubbed TEMP-ASSURE Validated service, conforms to current Good Manufacturing Practices (cGMPs) and includes a validation master plan.

TEMP-ASSURE Validated also sets standard operating procedures for the shipment of temperature-sensitive materials, FedEx said.

In addition to addressing concerns about the proper handling of temperature-sensitive materials, the new service facilitates compliance for customers regulated by organizations such as the Food and Drug Administration (FDA) and the United States Pharmacopoeia (USP), according to Custom Critical.

Customers receive a validated service that includes thermal-mapped vehicles, redundant data retention and hard-copy data logs documenting the temperature of the cargo hold during a shipment. This service also includes validation procedures and protocols, ensuring optimal quality according to cGMPs.

In addition to thermal-mapped vehicles, specialized care-in-handling and temperature-control equipment, TEMP-ASSURE Validated vehicles are equipped with a National Institute of Standards and Technology (NIST) traceable data logger and temperature probes that record temperatures at different areas of the cargo box.

According to Jim Snider, vice president and general manager of White Glove Services, TEMP-ASSURE Validated provides a missing compliance link in the cold-chain, ensuring proper shipping temperature and record keeping while products are in transit.

"Our objective was to address the regulatory and quality needs of our customers," Snider said. "With this new service, we provide our customers with a validated shipping option that was painstakingly developed to address these needs."
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