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Collaborating to Meet The Challenge of Air Cargo Cold Chain Regulations: There are myriad regulations and good distribution practices (GDP) from national, regional and country-specific organizations. New European Union GDP guidance was published in March 2013. This comes in addition to guidance from: the Parenteral Drug Association’s Technical Report No. 39, “Guidance for Temperature-Controlled Medicinal Products;” the U.S. Pharmacopeia, Section 1079, “Good Storage and Shipping Practices;” IATA’s Perishable Cargo Regulations Chapter 17; and many other groups. read more
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IN COLD CHAIN, TRUST BUT VERIFY: Using New Technologies to Monitor Temperature-Sensitive Pharmaceuticals: Moving temperature-sensitive pharmaceuticals by air transport is an awesome responsibility. Biotech and pharmaceutical products are among the commodities with the highest value per air-lifted pound. read more
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COLLABORATING IN THE COLD CHAIN: The Case for SOP Three-Party Development: Moving cold chain cargo is like a football match. Players move down the field, encountering a path full of obstacles, threatening to make them lose the ball. To succeed, the team must decide each player’s role and responsibilities – critically – before the match. The same logic is essential in cold chain logistics, and the tool that helps make this possible is the Standard Operating Procedure (SOP) agreement. read more
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VALIDATED PASSIVE PACKAGING: Weighing the Costs and Benefits: Cold chain cargo must be held within specific temperature ranges to ensure product efficacy. This requires communication between stakeholders, refined operations, and an active or passive cold chain solution for maintaining the correct temperature. read more
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Ambient Profiles – The building blocks (Part 2): In my last article, I mentioned that ambient profiles must be a true representation of the temperature a shipping container experiences during transit from origin to destination sites. Failure to capture realistic temperature conditions in the supply chain will create inefficiencies and increase the risk. In this second article I will describe how ambient profiles should be built and what practices should be avoided. read more
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Ambient Profiles - Deciphering the Supply Chain Elements (Part 1): Selecting or building ambient profiles for the shipping container qualification is a difficult and intense task because an ambient profile requires a deep understanding of the distribution process and the logistics involved. read more
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Cold Chain Industry Forecast for 2013: I’d like to share with you some of the key points I gathered this year and my predictions for cold chain in 2013. read more
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Chilling out in Brazil - Post Show Report: I was very impressed about the quality of the event because the speakers, the topics that were presented as well as the audience itself was very diverse and offered something for everyone. Among the topics discussed were local regulations, validation, distribution (import to Brazil, domestic and last mile), security, ambient profiles, logistics optimization, etc. read more
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New GDP Guidelines Spell Substantial and Drastic Change for the Entire Pharma Industry: As per the GDP the main change will be related to ambient (15° to 25°C) shipment which will impact all the entire temperature controlled transportation and qualification processes. read more
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A Muted Outlook in 2013: Every one of us in the temperature assurance market would like to know if this will be a strong year for our collective businesses or not. It is very difficult to tell these days considering the ‘fiscal cliff’ discussions produced by our daily media outlets. read more
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Review of New Products Launched in 2012 for Cold Chain Packaging: As 2012 comes to an end, we take a look at the Cold Chain packaging companies that launched new products in 2012. We collected data sent to us by manufacturers and combined it with our own research of publications and press releases throughout 2012. read more
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Cold Chain Market Trends for Suppliers: Trends. In everyday life, people talk about trends but sometimes they are difficult to see if you are too close to the action. In business, strategic minds try to decipher market trends to assess the appropriate direction of their customers & competitors and therefore the next steps their own company should take to be ahead of the actions that result from the trend. read more
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NIH Funded Silk Study Questions: In July the NIH News published research that states: “Researchers funded by the National Institutes of Health have developed a new silk-based stabilizer that, in the laboratory, kept some vaccines and antibiotics stable up to temperatures of 140 degrees Fahrenheit.” In order to better understand the implications to the cold chain market of these findings, I sought out Dr. David Kaplan, Tufts University, and asked him a few questions that came to my mind as I read the NIH News research. read more
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Importance of Cold Chain in Latin America: To assure the cold chain, we should have robust processes, suitable qualifications, effective training programs, risk assessments and back-up plans, challenged periodically. read more
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Rerouting Power. Reshaping Health: Rapid progress was made in implementing this innovative cold chain strategy after Energize the Chain presented its strategy to a receptive audience of cell tower operators and suppliers at the GSMA Green Power for Mobile Conference in Mombasa, Kenya in March 2011. We developed a very close working relationship with Econet Wireless, the major cell tower operator in Zimbabwe. read more
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Events of Interest
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Cold Chain & Temperature Control Distribution Summit
June 9, 2011
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Designing a Quality Strategy for Cold Chain Supply in Latin America
July 5, 2012
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Cold Chain Monitoring Devices: The Good, the Bad & the Ugly
April 17, 2013
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Use of RFID in the Pharmaceutical Cold Chain
September 25, 2012
Register Now
Cold Chain IQ is an online community for the temperature control life science professional, Cold Chain IQ delivers insightful, unbiased information about today's 'hot topics'.
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Top Rated
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COLLABORATING IN THE COLD CHAIN: The Case for SOP Three-Party Development Contributor:
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Importance of Cold Chain in Latin America Contributor:
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Optical Illusions in Cold Chain Supply Contributor:
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