Defining Cold
Airlines and healthcare industries are at odds
By Kevin O'Donnell
A couple of month's ago, in my How Frozen is Frozen? column, I talked about frozen temperature variability in storage when conditioning gel pack refrigerants, and the impact it could have on packaging configurations, product, etc. A colleague from Montreal who works in the transportation industry, responded to that piece with this follow-up question: How cold is cold? Excellent question.
Having spent nearly 30 years in the healthcare industry, I have a very specific opinion as to what that word means. It comes from the storage temperatures defined by the U.S. Pharmacopeia (USP) -- cold is any temperature [above freezing] not exceeding 8º C.
Our discussion brought me to the realization that cold means different things to different people. Really. Think about it for a second -- and try to define cold. It's like trying to describe the color orange to someone who has never had the ability to see; the concept of cold can be vague and relative -- like, "How high is up?" or "How long is a rope?"
A Rose By Any Other Name . . .
Like the Inuit people, who have a near-infinite number of words for snow, and the word, "aloha," which has multiple meanings in Hawaiian, "cold" is one of the more amazing and versatile words in the English language. I Googled no less than 16 unique applications for the word, making it very nebulous and difficult to define. It can be used as an adjective, a noun, or a verb. But for the sake of this article we're going to look at the word "cold" as an adjective, as it relates to temperature.
Intrigued by my French-Canadian friend's question, over the next few days I asked several coworkers how they would describe cold. (Mind you, they work in the temperature assurance business.) Every person I asked was caught unawares and really struggled before formulating a concise answer, and to my surprise their responses varied wildly.
I decided to conduct a little informal, random survey. I e-mailed a diverse group of 20 individuals -- 10 who had a scientific or engineering background (in education or industry) and 10 who did not. I asked them to provide a quantifiable answer to this simple question: How would you define cold? (as it relates to temperature). Again, the responses varied. Believe it or not, some didn't seem to understand the question and missed the mark completely, others were very thoughtful. All of them were insightful. Here are some examples:
- "Cold is a [relative] measurement of temperature. Something can be cold at a certain temperature while the same degree of temperature is not considered cold when looking at something else. Example: coffee can be considered cold if it is in a cup on a desk for a long period of time while a soda will be considered warm if it is next to that cup of coffee at the same temperature."
- "The temperature of an environment in relation to a person's body temperature, most likely somewhere below 10 to 12 degrees Celsius."
- "Anything in the 2 – 8º C range." (two responses)
- "0 degrees C."
- "Cold is the absence of heat." (three responses)
- "Absolute zero."
- "Chicago in January." (three responses). Ha-ha, very funny.
Not only do people's perceptions and definitions about cold vary, but the term is defined differently in different industries. Even the word "refrigerate" has a distinct meaning in different cultures around the world. Certain countries in Africa for example, refer to a freezer as a refrigerator because the Refrigerator Company is a brand of freezer. This can be risky for freeze-sensitive products in packaging that has the word "refrigerate" or "store in refrigerator" emblazoned upon it.
But on a grander scale, in the world of perishable freight -- within which healthcare products are so often lumped, particularly within the airline and freight forwarding industries -- cold turns out to have multiple definitions.
In the 7th Edition of the International Air Transport Association Perishable Cargo Regulations, (PCR) Chapter 10, "Perishable Handling Procedures" section 10.3.1.1.1, defines three "ranges of temperatures that perishables should be stored at: -18º C (for frozen products), 0º C to 4º C, and 8º C to 12º C."
They list separate temperature requirements for blood and blood components (PCR Chapter 4, "Perishable Facts and Types" section 4.2.9.2.2.2). Whole blood, red blood cells and thawed plasma calls for a range of 2-10º C. They list "frozen temperatures" for some items with no definition or range of temperatures.
Human tissues (PCR Chapter 4, section 4.2.9.2.2.4) lists a range from < -50º C to < - 130º C, although at these temperatures such components are generally transported on dry ice or liquid nitrogen in specialized/cryogenic containers. Still, it is confusing to a ramp worker, freight forwarder or other service provider who sees this on a label indicating the product's storage temperature.
But the potentially riskiest temperature category for healthcare products is defined by IATA in Chapter 5 of the PCR. It describes (in table format) the classification criteria used to identify perishable goods, including recommended storage temperatures. Section 5.1.1.4 "lists the applicable category assigned to temperature ranges in degrees Celsius":
Ambient = 15 to 20º C
Cool = 2 to 15º C
Cold = -9 to 2º C
Frozen = < -10º C
More than eight pages of perishable products -- from Acacia to Zinnia -- are listed. A quick read-through reveals tulips and tuna, ham and hibiscus, cabbage and cod, beef carcass and Bougainvillea, and salmon and Swiss chard. Nowhere are biologics, blood products, diagnostics, medical devices, pharmaceuticals or vaccines listed. They have there own special place, and for good reason. Chapter 17, "Air Transport Logistics for Temperature-Sensitive Healthcare Products," lists in section 17.10.1 the USP 29 definitions for temperatures such as "frozen," "cold," "cool," "controlled cold," "room temperature," "controlled room temperature," "warm," "excessive heat" and "protection from freezing."
Generally, cargo-handling personnel are neither aware of the difference, nor do they make the distinction. Few airlines and service providers to the airline industry have cold storage facilities on or near the airport. Even among those that do have such facilities, you will rarely find that they segregate or separate the classification to accommodate perishable's definition of cold and the biopharmaceutical industry's definition of cold.
Cold War
This disparity in definition between the airlines and USP (-9 to 2º C versus 2-8º C) is a source of concern and frustration for packaging engineers, quality organizations and transportation and logistics groups among biopharmaceutical manufacturers. It is unrealistic to think that the airline industry will change their operations to accommodate the biopharmaceutical industry when less than 5% of perishable freight volume transported by the airlines falls into the category of temperature-sensitive healthcare products.
The onus has been, and will continue to be, on the drug manufacturers to provide adequate packaging of their temperature-sensitive products to meet the challenges of the transportation environment, including (but not limited to) shock, vibration, relative humidity, solar radiation, light, pressure and of course, temperature.
There's Always Room for Improvement
As the size and frequency of temperature-sensitive shipments increases, more sophisticated packaging systems are being designed and deployed, both passive and active, by the biopharmaceutical industry. The value of their product and brand, both financially and humanely, is considerable. As a former Abbott colleague told me at a recent conference, "If you lose a container full of cabbage because it freezes, it's pretty obvious, and someone goes without their sauerkraut. If you lose a container full of vaccines headed for Botswana and it freezes, someone's going to die." It is this deep-seated mindset of responsibility within the biopharma industry that has led to such high expectations for the handling of freight and demands for tighter controls by transportation service providers, particularly the airlines. The airlines in the meantime -- strapped with soaring fuel costs, cutbacks and outsourced ramp personnel, are looking to reduce their involvement and avoid having to molly-coddle the biopharmaceutical industry's shipments through their system.
As an example, I recently toured British Airways' impressive 69,000-sq.-ft. Perish-able Cargo Terminal at London's Heath-row Airport. Built in 1999, it operates 24/7/365 and is capable of handling 140,000 tons of perishable cargo a day. Demand exceeded capacity shortly after the building was completed and BA is currently constructing a 10,000-sq.-ft. extension to the facility to meet the continuing increase in demand for heath inspection services as a first point of entry into the EU. Not only does the site handle the majority of the country's imported flora and fauna, the terminal was designed to make an additional profit by providing third party fulfillment services -- break-bulk, re-packaging, labeling and sorting -- to the nation's food wholesalers and retailers, according to Tony Wright, former manager Global Sales & Development for British Airways and now managing director of Exelsius, a cold-chain management consultancy located in London. For the biopharmaceutical industry, whose precious through-cargo represents only 5% of perishable volume and 0.04% of all IATA member airlines' profits,1 it's difficult to get an airline's attention, let alone make demands.
Certainly there are some airlines that provide better service to the healthcare industry than others, as well as specialty services within the transportation industry that have carved out a niche and cater to the specific and demanding needs of healthcare. IATA has taken a step forward to do something about it.
IATA's Cargo Services Group has established a cross-industry Time & Temperature Task Force to address the issues and close the gaps. Their goal: establish a minimum set of standards for the handling of healthcare products across the transportation continuum. In the meantime, the biopharma industry will have to continue with what's in place and know that improvements are forthcoming. The concern remains for the healthcare companies whose temperature-sensitive and freeze-sensitive products continue to ship in packages imprinted with the word "perishable" on them. They could be left out in the cold -- whatever that means.
Reference
1 Giovanni Bisignani, Director General and CEO of IATA, Keynote Address, World Cargo Symposium Mexico City, March, 2007
