The same can be said for transport packaging. To some, “a box is just a box,” the variety of styles and prices are nearly endless, and simply getting the product from point A to point B is enough. However, a certified insulated transport package isn’t just about getting it there — it is so much more than that.
As an enthusiast of both fine watches and high performance insulated transport packaging, I see many parallels. Let’s begin by looking at an attention-grabbing statistical extreme: 99.9%. Most of us have been sold on phrases like “kills 99.9% of germs on contact,” “air filters that trap 99.9% of all dust particles,” “guaranteed 99.9% pure,” etc. And who hasn’t used the expression, “I’m 99.9% positive,” in reference to something they felt supremely confident about? Is it just hyperbole? And what about that other 0.1%?
Well, if you were a watchmaker and created a timepiece with a movement that was 99.9% accurate, it would be off by a minute and twenty-seven seconds per day — an unacceptable level of tolerance even to the most casual wearer. That is why in an effort to distinguish themselves from the ordinary, the world’s foremost watchmakers, the Swiss, developed a standard for performance. Called the Contrôle Officiel Suisse des Chronomèteres, or the COSC for short, this independent not-for-profit laboratory mirrors ISO 3159 testing procedures to measure the accuracy and performance of a mechanical watch movement before it is assembled into a watchcase. Only Swiss-made watch movements certified by the COSC are allowed to bear the coveted and internationally protected label "Official Swiss Chronometer," or even use the word "Chronometer" anywhere on the product, packaging or advertising. A unique certification number is etched into each movement, and a corresponding 'bulletin de marche' (certificate of watch performance) is issued.
A chronometer is not to be confused with a chronograph. A chronometer is a precision mechanical instrument used for measuring time and is designed to maintain accuracy in spite of motion or variations in temperature, humidity and air pressure. A chronograph, on the other hand, is a wristwatch with multiple functions and dials that indicate and totalize elapsed time. Unlike set-it-and-forget-it quartz-driven battery operated watches, the operation of a precision mechanical watch movement requires manual or self-winding and is comprised of multiple moving parts: tiny gears, miniature screws and rotors, and hair-thin springs.
To certify as a chronometer, a mechanical watch movement has to successfully pass a series of seven COSC tests at three different temperatures and in five different positions over a period of 15 consecutive days. When all is said and done, they must prove accurate to within plus-six and minus-four seconds per day. The greatest deviation between the fastest and slowest rate must not exceed five seconds, and the average deviation must not exceed a maximum of two seconds per day regardless of its orientation and exposure to various temperatures. Successful completion certifies the movement to be, at a minimum, astonishingly 99.994% accurate. That’s nearly 100 times more reliable than the advertised germ-killing claims of even the most effective hand sanitizer.
More than a million official chronometer certificates are issued each year. This sounds like a lot, but it represents only 3% of the entire Swiss watch production. Most fine modern mechanical watches are likely to match COSC performance standards but many manufacturers simply choose to forego testing and bypass the certification process. Chronometers are definitely designed for a niche market.
Modern Mechanical COSC Certified Watch
|Minimum||+6/-4 seconds per day||99.994%|
|Nominal||+/-3 seconds per day||99.996%|
|Excellent||+/- 1 second per day||99.998%|
Where the Swiss watch industry has the Contrôle Officiel Suisse des Chronomèteres for establishing minimum standards of excellence in watchmaking, the packaging industry has the International Safe Transit Association (ISTA), the well-respected trade organization that pioneered the concept of package performance testing and certification more 60 years ago. The first global method establishing a minimum standard for the performance of insulated shipping containers was published by ISTA in 2010; Standard 20 and its companion piece, Standard 7E. Standard 20 is a design and qualification process that provides the structure and path to design, test, verify and independently certify a specific insulated shipping container. Included with Standard 20 is the Standard 7E, a set of global heat and cold thermal profiles, developed from data gathered in real world transport. ISTA states on their website that the “7E Temperature Profiles are the new standard for thermal transport testing.” (More on that later).
COSC certification performance tests assure the daily accuracy and consistency of a mechanical watch movement under a variety of “normal” operating conditions and user expectations. Likewise, ISTA Standard 20 provides a high degree of confidence that a selected insulated shipping container or packaging system can repeatedly hold designed product loads within an acceptable temperature range under a variety of “normal” operating conditions and user expectations throughout a given supply chain. Before Standard 20 came along, the level of performance testing was determined by individual organizations, creating a multitude of testing profiles, protocols, and variable proofs of performance. Standard 20 removes such subjectivity from the qualification process allowing for a direct 'apples-to-apples' comparison.
Commensurate with COSC’s certification process, only the results of an insulated transport packaging system that has been designed and tested in accordance to Standard 20 by an ISTA Certified Thermal Testing Laboratory can be submitted to ISTA for independent review and performance certification. If the documentation and results meet the minimum requirements, it is approved, and a certification mark for that packaging system will be issued by ISTA and can be printed on the external packaging.
Bringing the components of a mechanical watch movement all together on a small platform and getting them to work accurately is an amazing feat in itself, and to earn chronometer certification in the process is the pinnacle of the craft. Only by having a thorough knowledge of the subject, the highest quality components, and the expertise and care of the finest watchmakers and timers during assembly can such an achievement be made.
The same can be said for certifying insulated packaging systems for drug transport. The level of sophistication, knowledge and quality of the components and putting it all together so that it works accurately and repeatedly is essential. After all, we are talking about maintaining the quality of the drug product through a sometimes hostile (and sometimes uncontrollable) logistics and transportation process.
In general, the pharma industry knows and understands the need for a global standard for qualifying insulated packaging systems, but has been slow to adopt Standard 20 as the model. For an insulated shipping container to receive ISTA Certification, the design and qualification tests must be performed using the 7E profiles in Standard 20: “All thermal testing will be executed using programmed sequences to conform to 7E profiles, consisting of 72 hour profiles for heat and cold and 144 hour profiles for heat and cold.”
The reticence from the industry has been largely centered around the mandatory use of the 7E temperature profiles, which are statistically derived solely on data collected from the U.S. small parcel delivery environment, and which many shippers contend are either not challenging enough, or conflict with what they know and understand about their own global modes, models, processes, geography or lanes of transport.
ISTA has resoundingly responded to this concern with the recent establishment of a newly formed Thermal Council, a 20 member panel of experts from across the industry whose initial goals are to review and improve on Standard 20, and expand the number of temperature profiles in 7E through the collection of additional temperature data from various international transport lanes.
This may come as disappointing news to some, but not all Rolex watches are Certified Chronometers. Only about 65% of them hit that target. Don’t get me wrong; it’s still a beautiful, high-quality timepiece. But just like the finest of Swiss watchmakers who are not content with anything less than 99.994% accuracy, so too, are those in the pharma industry who insist on a higher degree of confidence in package performance for their products, who do not bypass the certification process like that pioneered by ISTA, and who distinguish themselves and their packaging from the ordinary.
It isn’t just hyperbole. When you get right down to it, an insulated packaging system used for drug transport is not just about getting it from point A to point B – it is, in fact, so much more than that.
Kevin O’Donnell is a senior partner at Exelsius Cold Chain Management – U.S. He serves as chair for the International Air Transport Association (IATA) Time & Temperature Task Force, is a member of the USP Expert Committee on Packaging, Storage and Distribution, and is a temporary advisor to the WHO. He blogs at www.coolerheadsblog.com. He can be reached at email@example.com.