
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.
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 |
Media
Contact: Eric Lindquist Entropy Solutions Office: 952-941-0306 |
# # #
[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