This article from Pharmaceutical Commerce discusses design approaches for shipments requiring maintaining temperatures of 2-8ºC, including the use of custom phase change materials, and high performance insulation in reusable applications. The advantages of using custom phase change materials in these applications, instead of liquid water, to prevent freezing are discussed in depth.
This article from Life Science Leader, discusses challenges in the distribution of temperature sensitive drugs.
Among these, is the increase in scrutiny by regulatory bodies with regards to storage and transport of BioPharma products; it is mentioned that "in 2008, the FDA conducted inspections of drug warehouses" and that "forty-two inspections were conducted, and 16 inspections resulted in the issuance of FDA 483" for observations relating to temperature storage and transport. An increase in inquiries by regulators relating to ambient products is also noted.
Key areas of the distribution stages are reviewed in detail, and best practices discussed. Temperature monitoring, including a survey conducted by Temptime to understand physician's concerns regarding breaks in the cold chain, and desire for unit level tracking capabilities, are also mentioned.
This article by Kevin O'Donnell, from the Advanced Degrees column of contractpharma.com, summarizes the IQPC 2009 Cool Chain Excellence Awards winners and runners-up.
This posting from Kevin O'Donnell's Cooler Head Blog discusses an article from a May/June issue of Pharmaceutical Outsourcing Magazine which provides the most well defined, science based, guidance on the use of Mean Kinetic Temperature (MKT) to date.
This article from Pharmaceutical Commerce, discusses air shipment of biopharma products, and how they may be affected in the future by potential rising demand and shrinking capacity. Several action items and alternate options for industry to minimize the impact of such a scenario are provided.
This article, from Pharma-Bio Transport, discusses proposed new regulations (Notice of Proposed Rule Making 75 FR 1302-NPRM: Transportation of Lithium Batteries) from the Department of Transportation (DOT) addressing the shipment of lithium batteries. Exceptions are still available in the proposed ruling which allow shipment of "extremely small lithium cells and batteries", which would not require shipment as Class 9 hazardous materials (i.e. lithium content at or less than 0.3 grams, or rating of 3.7 watt-hour or less). The final rule is targeted for publication December 2010.
This article from Pharma-Bio Transport discusses the total cost of ownership of cold chain shipping systems, and how reusable high performance solutions may have lower the total costs when compared to traditional single use systems, while providing environmental benefits.
This article from PMP-Digital discusses shipping systems, utilizing different technologies available for larger amounts of product, such as pallet quantities. Systems from Cold Chain Technologies, CSafe, Envirocooler, Entropy Solutions, Envirotainer, and Farrar Scientific are mentioned.
This article from PMP-Digital discusses a case study from Schering-Plough and their adoption of the Minnesota Thermal Sciences Credo system. Performance improvements, shipper selection, cost implications, and a return program with 84% return rate are discussed. Additionally, the use of Elpro Libero PDF temperature monitors programmed using product stability data, is also mentioned.
This article from the Emerging Health Threats Forum discusses a recent "proof of concept study published this week in Science Translational Medicine opens the door for distribution of vaccines that can be stored and transported without a fridge. Experts say the work holds promise, but further testing is needed before the technology can be used to make vaccination cheaper and easier in the remotest parts of the developing world."
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