New Phase Change Technology in Inflatable Single-Dose Shipper Meets Regulatory Guidelines for Controlled Room Temperature Shipping

 

Entropy Solutions’ Inflater Pack is the first single-dose shipping container to maintain mandated temperature sensitive 20-25°C controlled room temperature and 2-8°C refrigerated temperature ranges for 24-48 hours

 

MINNEAPOLIS — Sept. 30, 2008 — Until today, maintaining controlled room temperature (CRT), 20-25°C, for a package during shipment has never truly been possible. Companies and government organizations shipping small quantities or single doses of temperature-sensitive products (like pharmaceuticals or clinical trials) have found it difficult to maintain CRT during transit. Industry-wide state and federal regulatory commission standards[i] require CRT regulation as part of a company’s temperature-sensitive shipping operations. However, due to the lack of adequate technology on the market, complete compliance has been difficult to achieve.

 

That changes today with the introduction of the GREENBOXTM Inflater Pack from Entropy Solutions, a Minneapolis-based thermal technology development company. The Inflater Pack is the first inflatable shipping container, equipped with phase change material, designed to transport small quantities or single doses of temperature-sensitive products. In compliance with all regulatory requirements, the Inflater Pack maintains both CRT and refrigerated temperature ranges (2-8°C) for 24-48 hours. Its temperature-regulating ability is made possible by Entropy’s patented E23, E1 and E4 phase change materials, which are 100 percent safe for humans and the environment.

 

“For years, the life sciences industry has struggled to consistently achieve mandated regulations around controlled room temperature in shipment,” said Rafik Bishara, Ph.D., chairman of the Pharmaceutical Cold Chain Interest Group (PCCIG), Parenteral Drug Association (PDA). “Testing data shows the Inflater Pack, with Entropy’s phase change technology, provides the necessary thermal protection required for controlled room temperature medications and biologics. I consider this revolutionary because, simply, it works. No longer are the integrity, quality or efficacy compromised in the distribution channels as medications remain in the controlled room temperature range for the duration of their shipment.”

 

Pharmaceutical manufacturers go through extensive stability testing while developing and registering their product to understand the effect temperature has on its efficacy. Thermal excursions with any temperature-sensitive pharmaceutical may lead to a lack of potency, product degradation or possible health complications.

 

“Approximately 15-20 percent of our medications must be kept at room temperature – if they get warmer or cooler, they lose their efficacy,” said James Soucey, director of Clinical Services for Wal-Mart Specialty Pharmacy. “Keeping a medication at controlled room temperature during shipment has been mandated by federal and state regulatory commissions for years, but it just wasn’t possible given the options on the market. Wal-Mart did the very best it could, but now we have an increased level of confidence when we ship using the E23 panels and the Inflater Pack.”

 

In addition to unprecedented CRT protection, the Inflater Pack:

 

To learn more about the Inflater Pack from Entropy Solutions, please visit www.GREENBOXsystems.com or call 1-877-4GRNBOX.

About Entropy Solutions Inc.

Entropy Solutions Inc. is a thermal technology development company with its global offices based in Minneapolis, Minn. The company’s mission is to provide innovative, cost-effective, temperature-controlled packaging and shipping solutions for the transport and distribution of temperature-sensitive products throughout the world. Entropy Solutions’ GREENBOXTM technology is an innovative and next-generation passive thermal breakthrough in cost-effective, highly efficient shipping containers, intended for cold chain operations. Using patented phase change technology, GREENBOX is capable of maintaining narrow temperature ranges for record durations. The company’s primary focus is the life science, pharmaceutical and medical industries, where the ability to maintain global regulators’ mandated temperatures during the transport and delivery of temperature-sensitive pharmaceuticals, biologics and blood products are crucial to saving lives and advancing medical discoveries.

 

Media Contact:

Nikki Reed

Haberman & Associates

Office: 612.372.6473

Cell: 612.720.6790

nikki@habermaninc.com

 

Media Contact: 

Eric Lindquist

Entropy Solutions

Office: 952-941-0306

eric@entropysolutionsinc.com

 

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[i] Parenteral Drug Association (PDA) Technical Report No. 39 (Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment). Available at: www.pda.org

United States Pharmacopeia (USP) Chapter <1079> (Good Storing and Shipping Practices). Available at: www.usp.org