In the August 2009 Edition of the UK periodical Pharmaceutical Manufacturing and Packing Sourcer (PMPS), Mark Mohr, Manager of Product Development and Specialty Sales for Continental Airlines Cargo, examines the development of the air cargo market and is capacity for pharmaceutical cold-chain shipping.

It's nice to get an airlines perspective on the impact of the IATA Chapter 17 Perishable Cargo Regulations.

A pdf. of Mark's excellent article is attached below.

Dr. David Bernstein, the highly respected regulatory and technical consultant passed away on August 18th, 2009. David's long career in the clinical trials arena extended to several biotechnology and pharmaceutical companies, providing guidance in conceptual and implementation strategy and tactics for expediting the drug development process through integrating pre-clinical formulation efforts, preparation of investigational drug supplies and scale up to commercialization activities with the clinical development plan. He acted as the principal liaison between numerous virtual organizations and their CMC contractors.

David also lectured, developed training programs and educational seminars, and founded, organized and hosted the twice-annual Pacific Region Clinical Supplies Conference (PARCS), disseminatiing, sharing and discussing technology, logistics, regulatory issues and best practices involved in implementing the Investigational Clinical Supply Process.

It goes without saying that David Bernstein has always been proud of the PARCS Conferences - always providing a first-rate, professional and valuable asset to the industry. As a colleague he was among the most knowledgable, passionate, generous, and devoted individuals in his field. As a friend he will be missed and cherished for his warmth, wit and his wisdom.

Donations in David's name can be made to:

C.E.D. Orphanage
Tony Navaro
C.E.D. Society
P.O. Box 41360
Santa Barbara, CA 93140-1360
(805) 845-8757

In an effort to curb pollution from the seemingly ubiquitous white foam plastic coolers abandoned by careless boaters and river-floaters, the Missouri State Legislature inadvertanly banned  the wrong plastic - polypropylene - instead of expanded polystyrene.

The result can potentially land you up to a year in jail if you bring Aunt Millie's potato salad in a Tupperware bowl to a river picnic. The snafu also means that boaters and river-floaters who pollute the waterways with discarded EPS foam coolers can do so without fear of reprisal.

Apparently, show me the difference between PS an PP, was not  stated in the "Show Me State." Missouri Bans Wrong Plastic From Rivers

The temperature at which the frozen gels are conditioned have a direct and variable influence on the package's performance and longevity. Example:

The graph is an average culled from multiple tests and illustrates 1.) equilibrium at various frozen temperatures, 2.) time to attain phase temperature of 0°C +/-1°C, and 3.) the consequent longevity of the gel pack. In each test, identical 16 oz., 0°C phase change gel packs were probed with thermocouples and conditioned simultaneously in freezers set at -10°C, -20°C, -30°C and -80°C. They were removed simultaneously after 48 hours and placed into a controlled temperature chamber at 23°C +/- 1°C. Data were then logged at 15 minute intervals over a 48 hour period.

There is evidence of an obvious performance difference. The lower the temperature, the more exaggerated the effects of thermal shock. It is more pronounced and of longer duration, decreasing the air temperature within the package and increasing the threat of pulling the product temperature out of specification, possibly below 0°C. Attempting to artificially increase the longevity of the package by freezing the gel packs at lower temperatures extends the thermal shock curve but does nothing to extend the duration of the heat of fusion. Each gel pack contains a finite amount of energy, called enthalpy. For instance, all 16 ounce 0°C phase change gel packs contain roughly 179 kilojoules of energy. Regardless of what temperature the gel packs were frozen, once they reached their phase change temperature, the graph shows that they all performed the same and melted essentially at the same rate, if not the same time. 

You can find more on this topic in the following blog archives:

March 2009

April 2006