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October 2006 Revolutionizing the Cold Chain Volume 206, Number 10 |
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In This Issue · Rafik H. Bishara, Ph.D. Joins Board of Directors · Kodiak's AC25 · USP <1079>: Summary · Kodiak Advantages: Value Point #8 More informative. Easier to use. See all of the products in the Kodiak line. How does it work? Trade shows and conferences. Check out past editions. Is there a Kodiak authorized distributor in your region? Want to become one?
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Rafik H. Bishara, Ph.D. Joins Board of Directors
President and CEO of
Kodiak Thermal Technologies, Inc., Donald Pagel announced the election of
Rafik H. Bishara, Ph.D. to Kodiak’s board of directors
“Dr. Bishara is a strong addition to our Board. His insight and current activities in the cold chain community will help our company with a fresh look at the needs of this rapidly developing industry,” said Pagel.
Until it was acquired by the Carrier Corporation, Dr. Bishara served on Board of the Sensitech, Inc. between the years 2005 to 2006. Dr. Bishara had previously held the position as Director, Quality Knowledge Management and Technical Support, Eli Lilly and Company. During his 35 year tenure at Eli Lilly, Dr. Bishara was responsible for the Quality Knowledge Management, Global Compendial Affairs, Stability and Distribution Excellence, Global Product Protection, Special Security Substances and Controlled Substances Administration. Dr. Bishara is frequent invitee at industry leading conferences. He has authored numerous articles and has been a technical advisor to several organizations on best practices for Cold Chain Management. Dr. Bishara received his Ph.D. from Purdue University, Indiana.
See the full news release at www.GoKodiak.com
Kodiak's AC25 - Blood/Vaccine Container
The Kodiak AC25 Active-Cool Container uses leading-edge Free Piston Stirling Cycle (FPSC) technology. This exciting new technology is 70% more energy efficient and 40% more thermally efficient than older thermoelectric technology.
The
AC25 reusable container is designed for many repeat uses. The FPSC
technology
The AC25 can run on both 12 volt DC as well as 115 volt AC. The thermal efficiency of the AC25 allows it to continue to run efficiently even in very hot ambient environments. The result is a leading-edge container that you can trust to manage your portable cool and frozen goods transportation.
For more information on Kodiak's AC25 Active-Cool Container and the full line of Kodiak's intelligent temperature-regulated cold chain shipping containers, please contact Harry Smith, VP of Sales & Marketing at phone number 713.686.1553 ext. 15 or by email at hsmith@kodiaktech.com. To view our full product line visit us on the web at www.GoKodiak.com
USP <1079>: Summary - Validation Profiles
The
U.S. Pharmacopeia (USP) <1079> “Good Storage and Shipping Practices”
The USP <1079> tells us that:
v “Validated temperature-and/or humidity-monitoring technologies can be used to monitor the overall environmental effect on compendial (see references) articles during shipment and distribution.” v “Temperature profiling “should be conducted in both summer and winter” and “the temperature profile report should provide recommendations.”
Kodiak regularly performs validation testing on all of its temperature-critical shipping containers. Kodiak’s intelligent temperature-regulated cold chain shipping containers deliver desired temperatures without frozen gel, ice packs, dry ice, batteries or electric power sources and are robust enough to perform well in extreme ambient environments. Kodiak’s patented temperature-regulating system maintains an internal temperature of +2°C to +8°C for 5 days at an average ambient temperature of 25°C, reducing loss, returns and waste. Kodiak is the technology leader in developing intelligent temperature-regulated containers used in the transportation of temperature-critical products.
If you would like to receive a copy of The U.S. Pharmacopeia (USP) <1079> “Good Storage and Shipping Practices” , please contact The USP customer service department at 800.227.8772
References 1. USP <1079> Good Storage and Distribution Practices www.usp.org 2. Compendial standards define what is an acceptable article and give test procedures that demonstrate that the article is in compliance. These standards apply at any time in the life of the article from production to consumption. Thus, when tested from the viewpoint of commercial or regulatory compliance, any specimen tested as directed in the monograph for that article shall comply. Tests and assays in Pharmacopeia prescribe operation on a single specimen, that is, the singlet determination. www.fda.gov 3. Sensitech Inc. (2006, March) <1079> Overview, Retrieved October 2, 2006 from http://www.sensitech.com/coldchain_info/1079/1079_DataSheet.pdf 4. Kodiak 150 Hour Summer Profile Validation Results (click to view) 5. Kodiak 150 Hour Winter Profile Validation Results (click to view)
Kodiak Advantages: Value Point #8: High Visibility Labeling
Kodiak’s intelligent temperature-regulated shipping containers display high
visibility labeling. One benefit of this type of labeling is that it enables
the container to be easily identified
Kodiak’s full line of containers offers cutting edge
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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on September 7, 2006. Dr. Bishara currently chairs the Pharmaceutical Cold
Chain Discussion Group (PCCDG) of the Parenteral Drug Association (PDA).
is a
publication that has significantly impacted the scene of safe handling,
storage and distribution of pharmaceutical products. The USP <1079> can be
used as a blueprint by anyone in the business of distributing, shipping or
storing pharmaceuticals and other temperature-critical applications. It
offers guidelines that can be used to maintain the integrity and quality of
temperature-sensitive cargos from the manufacturer until it reaches the end
user.
as whether it is a frozen unit,
refrigerated unit or a room temperature unit at glance. The labeling on
these units will also alert the handler/user of the direction or position
that the container should placed in.
technology in the
shipment of temperature-critical products. Kodiak containers incorporate
patented technologies to maintain an internal temperature of +2°C to +8°C
for 5 days at an average ambient temperature of 25°C.