Where cooler heads prevail

Advanced Degrees: Recognizing Pharmaceutical Cold Chain Excellence

Kevin O'Donnell — Mon, 08 Mar 2010 18:44:51 -0600

Greetings from beautiful Vancouver, British Columbia where the 4th IATA World Cargo Symposium is about to get underway.

It seems like I'm constantly running a day behind. So before getting consumed in pharmaceutical air cargo issues, I thought I would take a moment to link you to my latest Contract Pharma article. For all the controversy that can surround industry award competitions, the net gain here is that the patient ultimately benefits — and regardless of what you think about industry awards, that is a very good thing. The 2010 IQPC Cool Chain Excellence Awards.

Keep it real.

Abbott & Lilly Weigh-in on Use of Mean Kinetic Temperature (MKT) in Distribution

Kevin O'Donnell — Tue, 02 Mar 2010 16:01:49 -0600

There has been much discussion (and confusion) regarding the applicability of MKT in the handling, storage and distribution of temperature-sensive pharmaceuticals over the past 18 months or so. Late last spring, a posse of five industry experts published a paper to add clarity to this often confusing topic. The group consisted of an Eli Lilly & Company engineer, regulatory scientist, a retired QA / Technical Support Director, and a Research Advisor, who collaborated with a Distribution QA Director from Abbott Laboratories. Their five page article was published in the May/June issue of Pharmaceutical Outsourcing Magazine.

At issue, and the answers the authors strove to assess and resolve was: can ...

WHO & PDA Pharmaceutical Cold Chain Management on Wheels

Kevin O'Donnell — Wed, 17 Feb 2010 13:42:11 -0600

This elegant quote, attributed to the American Pulitzer Prize winning author, Willa Sibert Cather, is the theme for the 2010 Pharmaceutical Cold Chain Management Course on Wheels, the 7 day, 551 km, full immersion supply chain experience sponsored by the World Health Organization and the Parenteral Drug Association.

2010 marks the third consecutive year the highly regarded training course (2010 IQPC Cool Chain Europe Award Winner for Best Temperature Control Logistics Project) will wind its way through the mountains, valleys and along the seacoasts of western Turkey - from Istambul to Izmir. The course is limited to 15 participants and ...

WHO Posts Open Comment Period on draft Cold Chain Management Document

Kevin O'Donnell — Mon, 01 Feb 2010 16:08:14 -0600

Dr. Umit Kartoglu of the World Health Organization (WHO), presented the draft of the long awaited Harmonized Guidance for the Storage and Transport of Time and Temperature–Sensitive Pharmaceutical Products at the IQPC Cool Chain Europe 2010 Conference in Amsterdam, Netherlands last week.

The 41 page document consolidates regulations and guidance on the storage and distribution of temperature-sensitive pharmaceutical products from a wide range of international sources into a single, relatively short document. The guidance has been prepared in close consultation with the WHO Task Force on Regulatory Oversight on Pharmaceutical Cold Chain Management whose members have been central to the review ...

Advanced Degrees: Regulatory Changes and Guidance on Temperature Controlled Distribution 2010

Kevin O'Donnell — Mon, 01 Feb 2010 15:30:01 -0600

Anyone involved in the manufacture and distribution of time- and temperature-sensitive drugs over the past decade has seen a significant evolution to the process. Manufacturing has gone global, distribution has become more diversified and there has been a surge in the manufacture of new biologic drugs. Guidance and regulations have barely been able to keep up with the growing demand and popularity of these therapies. There has been an increased awareness by industry and additional scrutiny given by federal regulators (FDA and other global regulatory bodies) for more transparency and documentation to support medicinal products in distribution. This includes a ...

IATA Time & Temperature Sensitive Handling Label jpeg & Specifications

Kevin O'Donnell — Thu, 14 Jan 2010 12:38:19 -0600

Since IATA is not in the label business, they do not provide any handling or dangerous goods labels. They have to be purchased directly from label manufacturers.

Attached below you will find the new specifications (November, 2009) for IATA's Time and Temperature Sensitive Healthcare Product Label.

Podcast: Temperature Controlled Distribution, Regulations and the Future of Biopharmaceutical Cold Chain

Kevin O'Donnell — Tue, 05 Jan 2010 16:30:18 -0600

I recently participated in an IQPC podcast on Temperature Controlled Distribution, Regulations and the Future of Biopharmaceutical Cold Chain, which included some 2009 milestones and what the industry might expect in 2010.

Topics discussed included:

The benefits of Cold Chain conferences like those organized by IQPC
Takeaways from the first IQPC Clinical Trials Logistics conference
The most significant changes to temperature sensitive drug distribution in 2009
What can the industry expect in 2010 in the way of new regulations and guidance for the distribution of time- and temperature-sensitive products
Areas of growth in the pharmaceutical industry over the next few years

Download ...

Where in the World?...

Kevin O'Donnell — Tue, 05 Jan 2010 15:25:37 -0600

The following is a running list (newest to oldest) of conferences, meetings, round tables, webinars, trade shows, and related cold-chain events where I will making a presentation. Links provided. I hope to see you there!

September 22-24, 2009

USP Annual Scientific Meeting 2009 - North America

Sheraton Centre Toronto Hotel,

Toronto, Ontario, Canada

Presentation: (Sept. 24th), Air Transport Logistics for Time & Tempeature-Sensitive Healthcare Products: Meeting the Requirements of the New International air Tranport Association Regulations

_______________________

September 21st - 24th, 2009

IQPC 7th Annual Global Forum Cold Chain Distribution for Pharmaceuticals

Philadelphia Convention Center

Plenary Chaiperson for Transportation and Logistics Section ...

Ed Kelly, Architect of the TSA 100% Cargo Screening Program, Dies at 67

Kevin O'Donnell — Fri, 11 Dec 2009 12:33:02 -0600

It is with great saddness that I inform you that our industry colleague, Ed Kelly, head of the U.S. Transportation Security Administration's cargo division, died on Friday, December 4th at Inova Alexandria Hospital in Virginia as a result of complications from Legionnaire's Pnuemonia.

A longtime freight industry executive, Kelly had led TSA’s cargo security branch as general manager since September 2006. He oversaw a staff of more than 50 at the agency’s Washington headquarters as the TSA worked to implement tough new security regulations that are still being phased in across the air cargo industry.

Industry officials said his strong experience and ...

Advanced Degrees: It's Not Just Cold-Chain; It's Personal

Kevin O'Donnell — Tue, 17 Nov 2009 14:18:38 -0600

During the week of September 21-25, I attended and served as plenary chairperson at the 7th Annual IQPC Cold Chain Distribution for Pharmaceuticals Conference in Philadelphia and delivered a presentation at the United States Pharmocopeia Annual Scientific Meeting in Toronto. It was a hectic week.

I always look forward to these events - not only to keep up with what is going on within the industry - but to meet and socialize with the many colleagues, friends and associates I have had the pleasure to know over these many years in cold-chain - many of whom I get to see only once ...

The Cold-Chain Chronicles: 24 Hour Worldwide Air Traffic Video

Kevin O'Donnell — Thu, 05 Nov 2009 15:45:04 -0600

I have had several delegates at recent Cold Chain Conferences requesting a copy of the 24 Hour Worldwide Air Traffic video which I have included as an introduction to many of my IATA presentations. Here's the link to the Zurich School of Engineering who produced the video. Enjoy!

BTW: Care to guess how many flights this video represents in a 24 hour period?

Answer: Globally, there are approximately 85,000 flights daily!

IATA Ammends Time & Temperature Sensitive Handling Label

Kevin O'Donnell — Tue, 03 Nov 2009 11:18:03 -0600

The Live Animals & Perishables Board of the International Air Transport Association (IATA) voted last week to ammend the orientation of the Time & Temperature Sensitive Handling Label following concerns by the US Department of Transportation (USDOT) and the International Civil Aviation Administration (ICAO) that the label might possibly be confused with Dangerous Goods labeling.

The label color, graphics, and verbiage will remain the same. However, the orientation of the label (a four inch square applied to the outermost transportation package "on point") "should be rotated 45 degrees so that it appears as a square and not a diamond," declared David ...

Advanced Degrees: Outside The Box

Kevin O'Donnell — Thu, 15 Oct 2009 16:25:28 -0500
This month marks Contract Pharma's 10th Anniversary Issue. I thought I would structure my column around that milestone and made a list of 10 essential considerations for a qualified, temperature-controlled packaging system. The list is by no means exhaustive but hopefully you will glean some nuggets and find it helpful.

PDA Europe to Offer Cold Chain Management Course in Berlin

Kevin O'Donnell — Thu, 01 Oct 2009 08:19:56 -0500

For those of you planning to attend the PDA Europe Pharmaceutical Cold Chain Management Conference next week in Berlin, you should note that there are a few seats remaining for the PDA post-conference Cold Chain Management Training Course Global Regulations & Standards; Influences on Cold Chain Distribution, Packaging, Testing and Transport Systems, on Thursday October 8th and Friday, October 9th, which will be given at the same location as the conference.

This course is currently offered but once a year in Europe. Further details here.

Advanced Degrees: Following up on Follow-On Biologics

Kevin O'Donnell — Thu, 10 Sep 2009 16:01:32 -0500

The anticipation of pending legislation that will allow a pathway for the FDA to approve follow-on biologics presents a potential boon for insulated packaging providers and other supply chain partners.

The September issue Advanced Degrees column in Contract Pharma is the second in a two-part series on biosimilars and cautions those who may be fool-hearty enough to try and shortcut qualifying thermal packaging for biosimilars.

You can link directly to the article here.

Pharma Takes Flight

Kevin O'Donnell — Fri, 28 Aug 2009 16:57:33 -0500

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.

Industry Loses Leading Regulatory Advocate in Clical Trials

Kevin O'Donnell — Fri, 28 Aug 2009 15:40:03 -0500

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.

It goes without saying that David Bernstein was always been proud of the PARCS Conferences that he founded, organized and hosted for so many years - always providing ...

Missouri Bans Wrong Plastic From State Waterways - Tupperware Now a Criminal Offense!

Kevin O'Donnell — Mon, 24 Aug 2009 15:08:21 -0500

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 ...

Will conditioning gel packs to various frozen temperatures have an impact on the performance of a package?

Kevin O'Donnell — Fri, 21 Aug 2009 09:54:52 -0500

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 ...

Advanced Degrees: You Say "Generic," I say "Follow-On"

Kevin O'Donnell — Tue, 28 Jul 2009 11:36:15 -0500

The difference between the terms biogenerics and biosimilars ismore than just semantics; as are the two Bills currently before Congress to establish a pathway for licensure of biosimilar products. Just how different are they and what could it mean to the biopharmaceutical industry and to patients ? The August Edition of Advanced Degrees explains.

Note: since publication, the US Senate, led by Ted Kennedy (D-MA) has proposed a 12 year patent exclusivity on biologics. This is in response to the Waxman (D-CA)Bill, which proposes a 5 year limit, the Echoo (D-CA) Bill, advocating 14 years; and the White House, which proposed ...

Argentina's new Law: "Regulating The Cold Chain of Medicines" out of Touch with Reality

Kevin O'Donnell — Fri, 17 Jul 2009 15:56:46 -0500

"It has finally happened," a cold-chain colleague called to tell me.

"What has?" I asked.

"It was only a matter of time before some government in their infinite wisdom authorized that the basis for the quality of medicine shall be determined by the temperature to which it has been exposed during its lifetime and that the consumer- the most unqualified individual in the entire supply chain - should make that call," he bemoaned.

He then forwarded to me The Official Bulletin of The Republic of Argentina Law for Regulating The Cold Chain of Medicine.

"This is such a bad idea on so many levels," he said of the one-and-a-half page document, "that I hardly know where to begin. And it's Argentina. ARGENTINA! Like they have the infrastructure and processes in place to pull this off!"

In fairness to you, gentle reader, here are the specific articles of the Argentine law causing so much consternation:

ARTICLE 1: Within a period of two (2) years from the time the present law takes effect [enacted March 26, 2009], all medicine for human or animal use containing thermolabile active principles must have a temperature indicator incorporated in the individual container that is indelible, unalterable and irreversible, and that will provide confirmation that said product has not lost the cold chain by the time it reaches the consumer.

ARTICLE 2: The indicator will be installed by the factory and must remain on the medicine, even on the individual consumer unit.

ARTICLE 3: For multi-dose packaging, the indicator must remain on the container, so that the consumer can check to see that the cold chain was not interrupted on the product in his or her possession, thus denaturing or rendering the medicine's original properties inactive.

"While seemingly well-intentioned, it is obvious to anyone with any knowledge of the distribution of cold-chain drugs, that this is not only impractical, but it is completely opposed to all current best practices acknowledged and accepted by regulators globally," my friend cried. "The last thing we need is for other countries to jump on this band wagon. We've come so far - this could mean a giant step backwards for the safe distribution of drugs! This is the worst proposal to come along since e-pedigree!" he shouted.

...I couldn't agree more.

Links to IATA's New Regulations for Time and Temperature-Sensitive Healthcare Products

Kevin O'Donnell — Fri, 19 Jun 2009 15:45:37 -0500

With only ten days to go before the new version of IATA's Perishable Cargo Regulations take affect, (July 1, 2009), I thought it would be helpful to provide links to those with questions on how and where to obtain the new regs, along with an explanation of the handling label requirements (voluntary for one year, required after July 1, 2010), and provide artwork for the new handlingl abel.

IATA Perishable Cargo Regulations

New Training Requirements for Time & Temperature Sensitive Handling Label

Advanced Degrees: Consistency is Key to Good Cold Chain Management

Kevin O'Donnell — Tue, 09 Jun 2009 10:56:53 -0500
What could a group of women joggers and cold chain possibly have in common? Link here to find out.

There's More to Indianapolis in May Than the "500"

Kevin O'Donnell — Wed, 20 May 2009 10:32:46 -0500

This was an inaugural conference co-sponsored by the State of Indiana Health Industry Forum and the Indianapolis Airport Authority.

The purpose was to unite the Midwest’s experts in healthcare logistics, distribution and manufacturing and to examine industry trends, challenges and best practices.

The targeted audience was supply chain executives throughout the healthcare value chain.

The goal of the one day conference was to showcase the advantages of the Indianapolis area and more specifically, the Indianapolis International Airport (IND), as a viable alternative for centralizing Midwest distribution of time- and temperature-sensitive healthcare products, and to nurture an understanding throughout ...

New IATA Regulations Take Effect July 1st, 2009

Kevin O'Donnell — Thu, 14 May 2009 14:40:52 -0500

The International Air Transport Association (IATA) will release the 9th Edition of the Perishable Cargo Regulations in June, with the content effective July 1st, 2009.

Commonly referred to as Chapter 17, (Air Transport Logistics for Time- and Temperature-Sensitve Healthcare Products), it has undergone considerable revision and represents the airline's pro-active effort to improve handling processes for high-value, high-volume healthcare cargo, including requirements for implementation a new handling label. More details are available in the Advanced Degree Column in the May edition of Contract Pharma.

Will Eli Lilly's Landmark Case vs. DHL Set a New Precedent for Damage Recovery Claims from TSP's?

Kevin O'Donnell — Wed, 29 Apr 2009 13:06:28 -0500

Last month, Eli Lilly and Company, along with its insurers, were awarded damages from a Florida District Court against Air Express International USA, d/b/a DHL Forwarding, for the mishandling of a temperature-sensitive shipment of insulin. The settlement was in the neighborhood of $10 million.

Lilly was able to document and successfully argue through the use of temperature data loggers that accompanied the product, that seven out of eight pallets in the shipment from Germany to Indianapolis were exposed to freezing temperatures while in possession of its contracted forwarding company, DHL, at Munich International Airport.

DHL unsuccessfully argued that Lilly did not present any ...

Comparing Ambient Temperature Profiles: Why No Two are Created Equal

Kevin O'Donnell — Tue, 07 Apr 2009 10:52:23 -0500

There was a great deal of discussion on the topic of temperature profiles last month at the PDA Cold Chain Management Conference in Bethesda, MD. Some interesting cases were presented supporting the use of MKT as one of several tools to establish profiles and failure criteria. But there can be potential pitfalls to putting all your eggs in one basket.

This month's Advanced Degrees Column in Contract Pharma explains why.

Gel Pack Refrigerants Encore: How Frozen is Frozen?

Kevin O'Donnell — Wed, 25 Mar 2009 15:56:19 -0500

The following is an excerpt from the Advanced Degrees column in Contract Pharma Magazine which appeared in the April ,2008 edition.

I have received many requests for links to graphs from a previous posting called "Gel Packs: How Frozen is Frozen?" It seems those graphs have disappeared into cyberspace when the coolerheads blog was updated. I am sorry for the inconvenience. That posting led to a subsequent and expanded article in the April, 2008 edition of Contract Pharma.

The following is an excerpt from that column. I hope this helps.

Frozen gel pack refrigerants, a critical component of temperature controlled packaging ...

Biosimilars and Cold Chain Issues

Kevin O'Donnell — Fri, 13 Mar 2009 14:32:54 -0500

This month's regular column in Contract Pharma Magazine takes a look at some of the issues swirling around the controversial topic of follow-on biologics, or what have been misleadingly referred to as "biogenerics." Also discussed are the measures certain segments of the logistics side of the industry have taken to stay ahead of the curve for when biosimilars' inevitable position in the market becomes a mainstream reality.

You can link directly to the article here.

Where in the World?...

Kevin O'Donnell — Wed, 04 Mar 2009 11:18:03 -0600

The following are conferences, meetings, round tables, webinars, trade shows, and related cold-chain events where I will making a presentation. I hope to see you there!

18 March 2009

International Air Transport Association (IATA)

Live Animals & Perishables Board (LAPB) Meeting

The LAPB will conduct a one day meeting to review, discuss, and vote on whether to accept the various recommendations of the Time & Temperature Task Force including revisions to the Perishable Cargo Regulations Chapter 17, Air Transport Logistics for Time- and Temperature Sensitive Healthcare Products, guidance on a Quality Management System, and recommnedations for a universal time- and temperature ...