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 may 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 Brennan, Head of Cargo Safety & Standards at IATA. "The concern is that confusion may arise as a result of the label orientation which could delay a time and temperature sensitive shipment, or lead to the package being opened, or that a dangerous goods inspector will interpret the label as dangerous goods, when in fact it is not, which could possibly lead to a fine." 

IATA went on to say that any original labels printed "on point" can still be used until inventories are exhausted, provided they are applied "on square."

REVISED IATA

TIME & TEMPERATURE SENSITIVE HANDLING LABEL

The Time & Temperature Sensitive Handling Label usage is specific to the healthcare industry. It was first introduced in Chapter 17 of the 9th Edition of the IATA Perishable Cargo Regulations (effective July 1, 2009), as an optional label to be used in conjunction with a Quality Management System between the shipper, freight forwarder, airline carrier and others in the distribution chain.

The label has been used on a voluntary basis by several shippers since July of this year and while no reports of confusion with dangerous goods has been reported, the LAPB voted to change the orientation before the label becomes a requirement on July 1, 2010.

In addition, IATA has defined the specifications and the Pantone color scheme for those wishing to reproduce the label for their operations.

You can link to IATA's specifications for the Time & Temperature Sensitive Label and the Perishable Cargo Regulations 9th Edition Chapter 17 Addendum here.

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.

"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.

Delta Cargo,who last November declared that it would no longer accept shipments containing devices powered by lithium batteries in devices operating in the cargo hold (including those in temperature-sensitive shipments), has modified its position.

In a letter dated January 27, 2009 (attached below), Delta Cargo  agreed to take only approved devices. To date, Sensitech data-logging devices are the only ones approved. Sensitech has provided Delta Cargo with sufficient documentation to demonstrate that their devices meet the exception requirements provided in Special Provision 188 of 49 CFR Part 172.102(c)(1). 

Delta goes on to say that unapproved devices will not be accepted. It will be incumbant upon each individual data-logger manufacturer to prove that the lithium batteries in their devices are in compliance with the applicable Dangerous Goods regulations for content, configuration, application, and testing and/or meet the Special Provision exception requirements.  

I have kept my ear close to the ground on this issue and no other airline has taken Delta's hard-line stance. But, as I mentioned in Pharmaceutical Medical & Packaging News ColdChain Suppliment Winter/09 published earlier this month, all data logger manufacturers using lithium batteries will need to prove that their battery type meets the UN Manual of Tests and Criteria requirements (171.7) for voltage discharge rates, robustness in packaging, and lithium metal content, by October 1, 2009. Being able to prove that the batteries in their devices meet the Special Provision exception requirements can be done anytime. Companies would be well-advised to have this documented in advance, and at the ready.

You can read more on this topic in the December Archives section to the left. 

The Seatle Post-Intelligencer and reporter Tom Paulson have put together an excellent website on the Gates Foundation international healthcare pledge.

The following is an exceprt on the challenges of vaccine distribution and administration.

You can link directly to the P-I website here. I have also provided a link to the site in my Favorites column to the right.

The Cold Chain: Keeping it cool is critical

For aid agencies who have made a mission of distributing vaccines, the world has become a tangle of electrical cords connecting refrigerators to the most remote villages around the globe.

They call it the Cold Chain. Without it, vaccines would spoil long before reaching their destination and with them considerable expense, effort -- and lives -- would be lost. But it is difficult to maintain the Cold Chain in countries where the power supply is as bumpy as the roads and anything that can go wrong does.

Through the efforts of many players on several continents the chain has been made stronger and its weak links easier to spot.

Ideal temperatures Some vaccines are sensitive to heat, others can be damaged by freezing. Each minute and degree above or below the ideal temperature shortens the vaccine's life. Some guidelines:

Monitoring vaccines It is difficult to tell if a vaccine has been exposed to high temperatures because there is no change in its appearance. Safeguards have been developed to warn health workers of vaccine spoilage.
When vaccines reach health clinics and are stored in refrigerators, they are monitored twice a day and readings are recorded on a chart to ensure a safe temperature is maintained.

Vaccine vial monitors
Every vial is also shipped with a temperature-sensitive label, developed by Seattle-based PATH, that health workers monitor during vaccination sessions.

SAFE If the inner square is lighter than the outer ring and the expiration date is valid, the vaccine is usable.

SPOILED If the inner square matches or is darker than the outer ring, the vaccine must be discarded.

The shake test
DPT, hepatitis B and tetanus toxoid vaccines can all be damaged by freezing. By shaking two vials, side-by-side, one that might have been frozen and one that has never been frozen, health workers can determine if a vaccine has spoiled.