News | July 2, 1999

Verifiable, Temperature-Controlled Container Introduced at CDC Conference

At the 33rd National Immunization Conference sponsored by the Centers for Disease Control and Prevention on June 23, ISOsafe, Inc. (Newtown, PA) introduced what it claims is the only electronically verifiable, temperature-controlled, portable container for transporting vaccines and other temperature-sensitive bioproducts.

Manufacturers of biological products have struggled with the "temperature problem" for decades. Keeping vaccines cold during transport is complicated by the chain of custody for these products: Temperatures become more difficult to control he farther products get from the manufacturer. That is why Merck, for example, will only ship certain vaccine products directly to the end-user. Clearly, manufacturers must be at least as aware of their products' "cold chain" they are of as their supply chain during manufacturing.

Maintaining optimal temperature from point of manufacture to point of use, which is critical for vaccine potency, can be difficult to ensure with conventional transport containers. Studies have shown that vaccines at approximately 63% of storage and transport sites are exposed to unacceptable temperatures before use. Breaks in the cold chain reduce the potency of vaccines and contribute to vaccine failure.

"We expect ISOsafe VTC (verifiable temperature control) to set a new standard in cold chain maintenance," said Patrick Kirwan, ISOsafe Managing Director. "The reduction in vaccine wastage resulting from verifiable temperature control will translate into substantial savings for healthcare systems throughout the world."

The lightweight, reusable VTC comes in two sizes: 5 liters (25 pounds) and 20 liters (34 pounds), and can be programmed to maintain an internal temperature differential to ambient of up to 43ยบ C. The VTC plugs into a vehicle's cigaret lighter or standard power source.

ISOsafe VTC is unlike any currently available bioproducts transport container, providing for the first time verifiable temperature control. Unique features include a patented air-flow technology to ensure uniformity of temperature throughout the interior of the container, frequent automatic monitoring and recording of internal temperature, visual and audio warning alarms to alert carriers to any temperature deviation, and tamper-proof, shock-proof casing. The container maintains the preset temperature environment through either cooling or heating in response to control sensor electronics, making it ideally suited for use in all climates, including subzero and tropical.

In addition to transporting vaccines, VTM can be used for shipping other temperature-sensitive medical and biological materials, including pharmaceuticals and pharmaceutical/clinical research materials.

Figure: ISOsafe VTC

"Today's options are limited mostly to styrofoam boxes containing dry ice or cold packs," said ISOsafe general manager Bill Hirschman. These products, according to Hirschman, cannot assure that products are stored and shipped at the right temperature. "The further the product goes from the manufacturer the crazier it gets. Was a vaccine kep at optimal temperature throughout shipment? It's a crap shoot."

By using thermoelectric cooling (or heating), VTM eliminates the "one size fits all" temperature control capabilities of simple cold boxes. At the same time, it allows temperature verification throughout a product's shipment from the plant to the end-user.

ISOsafe's VTC container uses thermoelectric cooling based on the Peltier effect (discovered nearly 200 years ago) to keep products within safe storage temperatures. Peltier coolers/heaters using no moving parts, compressors, or gases. The Peltier effect occurs when electrical current flows through two dissimilar conductors. Depending on the direction of current flow, the junction of the two conductors either absorbs or releases heat. In its simplest form a Peltier device (i.e., thermoelectric module) is based on a single semiconductor "pellet" soldered to electrically-conductive material on each end (usually plated copper). In this 'stripped-down' configuration, the second disimilar material required for the Peltier effect, is actually the copper connection paths to the power supply.

Benefits of the VTM include:

  • Verification of storage conditions at all stages throughout shipment
  • Immediately alerts the user should defined limits be breached
  • Verifiable information down loadable to PC or handheld computers
  • Powered from a wide number of sources with no user intervention
  • Maintenance of contents at consistent temperature, eliminating temperature gradients
  • Constant, user-defined environment by heating or cooling within precise limits, whatever the ambient temperature
  • Allows extended holdover time should power become disrupted

For more information: Bill Hirschman, General Manager, ISOsafe, Inc., 86 Walker Lane, Newtown, PA 18940. Tel: 215-579-9120. Fax: 215-579-9130. Email: bill.hirschman@isosafe.com.