It's hard to predict exactly what conditions a drug will experience during the distribution process. Will delivery be delayed
for a day or more by a blizzard, flood, hurricane, power outage, or holiday weekend? Will the product sit in the sun for hours
before it's loaded onto a plane or clears customs?
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.
The latest temperature-protecting packaging also qualifies as sustainable. Today's designs tend to weigh less and occupy a
smaller footprint than previous containers. In addition, they are less likely to rely on dry ice. Thermal containers frequently
are both reusable and recyclable, and may contain recycled content, too. Formalized reverse-logistics programs simplify container
reuse, cut costs, automate replenishment, and ensure that recyclable components are reprocessed rather than consigned to landfills
when they can no longer be reused.
We'll be seeing more
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).
To protect temperature-sensitive shipments better, several carriers have established specialized service programs and adopted
standardized temperature-control technology (Temp Control service, United Cargo, and AC Cool Chain, Air Canada Cargo).
AcuTemp RKN Temperature Management Cargo Units for air transport of temperature-sensitive goods. (PHOTO IS COURTESY OF ACUTEMP)
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).