Happy Holidays! From our Kodiak
family to yours, warmest
thoughts and best wishes for a wonderful Holiday Season and a very Happy New
Year!
Keeping Cool…
Manufacturers and supply-chain partners
attempt to define and standardize shipping procedures
and tests, while vendors work on reliable solutions. A new cold chain
article in Pharmaceutical & Medical Packaging News looks at new technologies
and trends trying to meet the needs of today and the future.
See the entire article at:
http://www.devicelink.com/pmpn/archive/06/11/002.html
Cold Chain Management
A main
focus of the global regulatory requirements and trends within the industry
all indicate an emphasis on the monitoring of storage and transportation
temperatures which pharmaceutical products are exposed to throughout the
distribution channel. The global regulatory requirements for temperature
monitoring will impact all parties within the distribution chain from
manufacturers to wholesalers to shippers. All parties within the cold chain
distribution system will be found responsible for the management of the
temperature sensitive materials while in their possession. The goal of the
WHO, FDA, USP, Health Canada and the European Union Guidance is to "increase
the importance of temperature control and monitoring to mitigate and
identify risks" regarding the efficacy and quality of pharmaceutical
products as they travel through the bewildering distribution chain. To
learn more about those requirements, how your firm will be impacted and how
you may implement the appropriate practices please refer to "Cold Chain
Management – An Essential Component of the Global Pharmaceutical Supply
Chain" by Rafik H. Bashira, PhD. View the complete article in the
January/February 2006 issue of American Pharmaceutical Review,
www.americanpharmaceutical.com.
FDA
www.fda.gov
PDA
www.pda.org
Health Canada
www.hc-sc.gc.ca
US
Pharmacopoeia
www.usp.org
World Health Organization
www.who.int/en/
Conference Updates
Future Pharma Congress
December 3–5, 2006
Daytona, Florida
Some of the world’s top
executives in the pharmaceutical industry are coming together for 3 days of
keynote presentations, workshops and panel discussions, designed to help
facilitate the advances that need to be made in order for these
organizations to remain innovative and at the forefront, within their
markets. Delegation includes 150 VP and C-Level Executives representing the
Pharmaceutical Manufacturing Industry.
http://virtusinternational.com/pharma/speakers.html
VIB
Clinical Trial Supply Conference 2006
October 24-25,
2006 Philadelphia, PA
This year’s Clinical
Trial Supply Conference was chaired by Tom Cote of Sanofi-Aventis and Mike
Dey of IPSEN included speakers from Cardinal Health, Astrazeneca, World
Courier, Sensitech, Sanofi-Aventis, J&J, Clinphone and Organon.
An excellent cold chain
presentation was made by John Monetti of World Courier with some assistance
by Henry Ames from Sensitech. John and Henry focused on the expanding
global market and the challenging cold chain needs created by that expanding
market.
Sales in 2005 for this
global market reached $602 billion of which $52.7 billion was in biologic
products which generally need temperature-controlled transportation. The
traditional pharma market grew by 7% where the biologics market grew by a
staggering 17.1% according the March, 2006 IMS Health Report. This trend is
expected to increase as genetic and biologic research and drug production
continues to expand well into the next two decades creating more and more
need for cold chain standards and more robust solutions to these needs.
For a copy of the full
presentation,
click here.
Kodiak Advantages:
Vacuum Insulated Panels (VIPs) and Patented Thermal Shield
Value Point: 5-Day Internal Temperature Hold Time
One of the advantages of
the Kodiak Container is the fact that it has the ability to maintain a 5-day
internal temperature hold time. This is
made possible by using vacuum panel technology and a patented thermal shield
as part of the Kodiak Container. This combined state of the art technology
of patented thermal shields and VIP's (vacuum insulation panels) is what
enables the Kodiak Container to offer 10 times the insulation capability of
ordinary foam insulation.
 The
Kodiak Container offers favorable conditions for extended life shipments of
payloads for 5 days or more, depending on the payload mass and ambient
temperature variables. The Kodiak Container also allows for accurate cargo
temperature in all environments. This will enable customers to reduce
spoilage and better plan for delays. With The Kodiak Container, you also
have expanded shipping days which makes it possible to ship on a Thursday or
Friday and still maintain your product integrity.
For
more information on Kodiak temperature-regulated cold chain shipping
containers, please visit us on the web at
www.GoKodiak.com. To request an
information packet, please email us at
info@kodiaktech.com.
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