Protecting the Cold Chain - Pharmaceutical Technology

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Protecting the Cold Chain
Makers of temperature-sensitive products constantly seek to ensure proper conditions during shipping and storage.


Pharmaceutical Technology


Insulated packaging


Vacuum-insulated panels and liquid refrigerant packs help the "Golden Hour Platelet Shipper" triple the length of time contents remain at the proper temperature.
Sensitive products generally require specialized packaging that may also include provisions for ice, dry ice, or gel packs. One new option designed for blood-platelet shipments features vacuum-insulated panels and liquid-refrigerant packs to maintain the US Food and Drug Administration's required temperature range of 20–24 C for two days in both summer and winter conditions. The result is a shelf life that is at least three times that achieved with traditional insulated shippers ("Golden Hour Platelet Shipper," Minnesota Thermal Science, Plymouth, MN).

A prequalified insulated shipping container maintains a temperature range of 2–8 C for 24 h and conforms to summer and winter weather shipping-condition requirements set by the International Safe Transit Association (ISTA, East Lansing, MI) in its ISTA 7d standard. For more stringent applications, 48-, 72- and 96-h versions are available ("TimeSaver 24," TCP Reliable, Edison, NJ).

Another prequalified thermal shipper capable of maintaining 2–8 C conditions combines polyurethane construction with refrigerants to provide protection for as many as five days and a 2744-in.3 payload ("Large-Capacity KoolTemp GTS-120" insulated container, Cold Chain Technologies, Holliston, MA).

To minimize environmental impact and reduce waste, Talecris Biotherapeutics, Inc. (Research Triangle Park, NC) specifies a shipping container that combines a recyclable corrugated box with interior insulation panels made of several natural minerals that are heated, spun into a fiber, and encapsulated in biodegradable plastic. "The integration of 'Control Temp Blue' containers into our supply chain will enhance the integrity of our products and minimize any environmental impact from packaging and shipping," says Jim Bacon, director of global demand planning and customer operations at Talecris. Besides the environmental benefits, the new containers offer longer temperature maintenance per inch of insulation, enhanced cushioning, and shock protection for Talecris's glass-packed products ("Control Temp Blue" container, R.N.C. Industries, Inc., Norcross, GA).

Several firms offer insulated bags that maintain product temperature for several hours. Generic insulated medical pouches rely on a three-layer structure consisting of reflective film, polyethylene foam, and food-grade film. The pouches are available in five stock sizes ranging from 12 X 10 in. to 21 X 21 in. This construction also blocks potentially damaging ultraviolet light. Custom designs of the washable, reusable, and recyclable bags can be printed in 10 colors. For added protection, a gel pack can be built into the bag ("Medtraveller" thermal bags, Coldkeepers, LLC, Thomasville, GA).

Another supplier of insulated bags and pouches recently installed a production machine that handles narrow webs of material to meet rising demand for smaller sizes. Bags and pouches are not only certified to be made of food-grade materials, but also provide unit-level traceability because each one carries a unique identification number ("Criomed" and "Criomed Plus" insulated bags, Termika US, Roswell, GA).


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
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Reducing drug shortages
70%
Breakthrough designations
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Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
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