Expanded Polystyrene (EPS); the plastic we love to hate. It’s been around for so long it’s hard to imagine what life would be like without it. Let’s face it, as plastics go, EPS is very conspicuous — large white pieces limitless in shape and size, not to mention the loose fill “peanuts” that seem to migrate everywhere. It’s obnoxiously voluminous. At the same time it troubles us to know that the containers we use to ship our temperature-sensitive healthcare products (as well as use to protect many of the consumer goods we purchase — everything from televisions to double lattes), is ultimately destined to lie in a landfill somewhere for centuries to come. It’s another inconvenient truth of 21st century life; one of those things we know we should do without but which we will never be prepared to relinquish. But in many respects, EPS has been unfairly vilified...

You can read the entire Contract Pharma article here.

The 6th Annual IQPC Cold Chain Distribution for Pharmaceuticals Conference was held

September 22-25, 2008, at the Philadelphia Convention Center, Philadelphia, PA. More than 300 delegates and 34 exhibitors participated.

Presentation topics were focused on logistics with an emphasis on international transport, clinical trials and the "last mile" of distribution. It was slightly more technical with less overt selling than in years past and there was no shortage of panel discussions and roundtables in addition to only a few case history presentations.  The event reflected the maturing of this segment of distribution as both presenters and audience were far more knowledgeable than in the past.  

The conference began with regulatory speakers from the UK and Canada providing updates to activities in their respective agencies. They concur that temperature monitoring will be viewed as a must-have, or a “critical component” to good distribution practices for time and temperature sensitive healthcare freight. Harold Rode of Health Canada was completely non-committal when pressed about when the agency is going to publish the revised edition of guide 0069 (currently under review).

Mary Foster of Catalent, and the person responsible for the re-write of USP General Chapter <1079> Good Storage and Shipping Practices, and stated that the new document draft ( 49 pages and more than 3X longer than the current edition) was submitted to the USP Expert Committee on Packaging. It came as a surprise to many in attendance that references to Mean Kinetic Temperature as it relates to transportation were removed by the USP 1079 revision committee and that they strongly recommended to the EC that it remain out of the document.

Other presentations of note: the new TSA 100% cargo screening regulations drew many questions for the presenter, Brad Elrod, Manager Global Logistics & Security, Pfizer, and  Jean-Pierre Emond from the University of Florida made a well documented presentation on testing he has done on the new generation of insulated sea containers and whetted the appetite of those considering the possibility of using them as an alternative to air freight. These containers are so well insulated that they hold only 40% of the payload of existing insulated reefers. He cited a reduction in freight costs by 40%. Their use is not without significant risk however, especially during loading and unloading at the port when there is no means to control the logistics or ability to provide AC power to run the refrigeration units. Emond objectively stated that the greatest drawback to this technology is that there are only 30 containers worldwide and the developer is not expected to play “build it and they will come.”

The “sponsors,” or service and supply partners to the industry appeared well organized. There were neary twice as many than at last year's conference (19). There is a definite shift in representation of those exhibiting, with 12 3PL and specialty logistics and transport providers, 10 data management companies and 12 packaging / platform providers. 

My regularly scheduled column in Contract Pharma can be read here.

Synopsis: The TSA is implementing new cargo screening procedures for all air cargo aboard passanger aircraft originating in the US. The program is likely to threaten timely delivery of goods. The two-stage program will require 100% compliance by August 2010. The TSA has developed a Certified Cargo Screening Program (CCSP) to help streamline the process. The article details the program and its potential impacts on the distribution of time- and temperature-sensitive healthcare products.

The following were overheard at cold-chain events this past summer, and are worth repeating:

"There are three topics on which there will never be agreement: religion, politics and MKT." - conference organizer

"My wife looks great in a little black dress. I could wear that same dress but I would have a hard time justifying why I should." - a cold-chain consultant's regulatory perspective as he explained why one company should be cautious about using another company's ambient temperature profile

"Vacuum panel insulation works much the same was as a Thermos bottle. Inside, it's able to keep hot stuff hot and cold stuff cold. But how does it know?" - a cold-chain educator's introduction to the principles of therodynamics

"There is a lot of crap to consider in the process of choosing a thermal packaging solution. And when I say crap, I mean CRAP: Container, Refrigerant, Ambient temperature exposure, and Pre-conditioning." - cold-chain educator

"I would like to introduce the man who is considered the leading global authority in pharmaceutical cold-chain management and logistics. Unfortunately, he couldn't make it. So, instead please let me introduce you to ____________" - conference host

For those of you who missed the opportunity in March or were turned away because the class was a sell-out; the Parenteral Drug Association Training and Research Institute (PDA-TRI) is once again offering their two day Cold Chain Management Course, Global Regulations and Standards: Influences on Cold Chain Distribution, Packaging, Testing and Transport Systems in conjunction with its annual PDA/FDA Joint Regulatory Conference.

The Training will take place following the joint conference on September 11-12th 2008. Details can be found here.

The course is only offered twice a year in the US and there are a limited amount of seats available.