As air-cargo screening rules tighten, shippers fear that the frequency and length of delays will increase. Delays can be disastrous for temperature-sensitive drugs. If temperature abuse renders a drug ineffective or hazardous, it poses a danger to patients. Monetary losses can be significant, too. Because many temperature-sensitive drugs carry extremely high price tags, a single temperature-abused shipment can cost millions.
To protect products from temperature abuse, drugmakers rely on an expanding array of tools to maintain shipments at the proper conditions. These tools also identify excursions above or below the required temperature range.
A prepaid shipping label expedites the return of the containers. Upon receipt, all containers are visually inspected, and any damaged components are replaced. Next, the containers are cleaned in compliance with 21 CFR 211.94. Before returning to service, thermal components are tracked by customer and serial number and tested to confirm that thermal performance has not degraded (AcuTemp Reusable Enviro-friendly Program Assuring Quality for AcuTemp Qualified Shippers, AcuTemp Thermal Systems).
Another program that inspects, refurbishes, cleans, and sterilizes returned containers is supported by web-based software. The software provides continuously updated reports and alerts on container status, inventory levels, and maintenance needs and allows a user to track its shipments (Credo Encore reverse-logistics services, Minnesota Thermal Science, MTS).
For air transport, this specialized service may include buying or leasing active temperature-controlled containers with proprietary air-movement, heating, cooling, and insulation systems that eliminate the need for dry ice. The compressor-equipped units, which are approved by the Federal Aviation Administration, the European Aviation Safety Agency (EASA), and Transport Canada, operate for more than 100 h on battery power, maintain temperatures between 4 and 25 °C in ambient conditions ranging from –30 to 49 °C, and provide payload space large enough to hold a full pallet. Longer hold times are possible if the unit can be plugged into an AC power outlet. The containers have successfully undergone operational qualification (OQ) at several pharmaceutical companies, including Pfizer. The OQ involved testing under a wide range of temperature setpoints, ambient conditions, shipping lanes, payload sizes, and transit durations (AcuTemp RKN Temperature Management Cargo Unit, CSafe).