ISTA International Transport Packaging Forum
03-29-2010,Orlando,United States 2010 PDA Pharmaceutical Cold Chain Management Conference & Training
04-12-2010,Bethesda,United States
Entropy Solutions has partnered with Cardinal Health to use their Pure Temp PCM (Phase Change Material) for refrigerated applications, using Cardinal Health's standard insulated reusable totes. The video discusses this partnership, and provides a good explanation of how custom PCM's work in these applications. Click title for video.
This article from Packaging Digest discusses a growing trend by biopharmaceutical manufacturers to address cold chain challenges by providing formulation and delivery alternatives. An oncology product from Watson Pharmaceutical, Trelstar, has been formulated as a freeze dried powder which can be reconstituted at the point of use by a patient.
This article from the Journal of Commerce discusses the initiatives from airlines, forwarders and container manufacturers to meet the projected increase in the flow of trade in pharmaceutical products.
This posting from Kevin O'Donnell's Cooler Head Blog discusses the draft document titled "Harmonized Guidance for the Storage and Transport of Time and Temperature–Sensitive Pharmaceutical Products", which has been prepared in consultation with the WHO Task Force on Regulatory Oversight on Pharmaceutical Cold Chain Management. The comment period expires on March 15, 2010.
This article by Kevin O'Donnell published in the Contract Pharma 'Advanced Degrees' column discusses the increase in regulatory focus towards temperature controlled biopharmaceutical products, as well as other temperature sensitive drugs, even if they are not in the traditional 'cold chain' category. Specific regulations and guidances undergoing revisions in 2010 are mentioned (IATA, Health Canada, TSA, USP, WHO, and PDA).
This article from Greener Package discusses Abbott's sustainability initiatives, including their use of the Entropy Solution's reusable green box thermal shipping systems with physician samples of a biologic that treats Crohn's disease.
This article from PMPNews discusses the efforts from ASTM International Committee F02 to develop a Standard Practice for Climatic Stressing of Packaging Systems. The objective is for this guideline to accurately reflect distribution environments commonly used by medical device manufacturers. Three environmental conditions are expected: Freeze, Desert and Tropical; these are to be based on industry experience, global climate, typical distribution duration and guidance from other procedures (ASTM D4332, ISO 2233 and ISTA). Upon completion of climatic stressing, users would perform ASTM D4169 (cycle 13), ASTM D7386, followed by ISTA or ISO 4180.
This posting from Kevin O'Donnell's Cooler Head Blog includes the specifications and JPG download of IATA's new time and temperature sensitive handling label.
This article from ARC Advisory group, briefly discusses the delivery by UPS of a temperature sensitive biologic drug, without signature receipt, into a hot mailbox - and how this is an example of the challenges facing the biopharma industry supply chain.
This article from Logistics Viewpoints discusses the shipping of temperature sensitive products by online pharmacies. The article gives an example of a shipment left inside of a mailbox for five days. There is also a discussion of ISPE current draft guidelines relating to cold chain distribution.
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