I had the great pleasure of meeting with a colleague from Russia recently, when we both happened to be in Geneva, Switzerland on separate business. Andrey Kukharenko is chief executive officer of THC Company in Moscow, engaged in the distribution of cold chain equipment to Russia and the Confederation of Independent States. He also provides consulting services on validation and GXP. Andrey is the co-founder and a principal participant in the national non-commercial association Cold Chain and Biotechnologies Partnership, an organization dedicated to the development and implementation of good practices in storage and transportation of temperature-sensitive products.
An effusive native Muscovite and former Russian Customs Officer turned pharmaceutical cold-chain specialist, Andrey beams with enthusiasm, he’s inquisitive, bright and ambitious — the perfect fit in a country that desperately needs more like him in our industry. I asked him for some insight on an article I wanted to write about on the challenges of shipping temperature-sensitive drugs to Siberia, that I thought might make for an interesting column. We could all learn a thing or two from his experience.
Andrey singled out the Siberian city of Yakutsk, population 270,000 and pronounced yaw KOOT sk, in the eastern Republic of Sakha as extreme, even by Siberian standards. Yakutsk is the capital city in Yakutia, a region that covers more than a million square miles (about twice the size as the State of Texas), and home to nearly one million hearty souls — and growing! Yakutsk is famous for a few things: it appears in the classic board game Risk, it boasts the richest concentration of natural resources on the planet (every element in the Periodic Table can be found there in abundance), and the fact that it can, hands down, claim to be the coldest city on earth, registering a blistering record low of -64.4° C. The average daily temperatures during December, January and February typically hover at a comparatively balmy -50° C.
Paralyzed by the brutally low temperatures, the city remains enveloped in a perpetual frozen fog and moves at a crawl; residents scurry from building to building to avoid frostbite which can develop within mere minutes; automobiles and trucks are left continuously running or their engines will seize; even wearing eyeglasses gets tricky: the metal sticks to your cheeks and will tear off chunks of flesh if you remove them outdoors.
Not only is Yakutsk cold, it is also extraordinarily remote: six times zones and 5,200 miles from Moscow. The northern boundary of the region is only a few hundred miles from the North Pole. The nearest railway station is more than 500 miles away and only one road leads into and out of the city, the Lena Highway or the "Road of Bones." Built by Gulag inmates, many of whom died in the process, it traverses 1,200 miles of the Siberian wilderness, leading eventually to Magadan on the Pacific Ocean. The road is only fully accessible in winter, when the rivers freeze over (the actor Ewan McGregor and his friend Charley Boorman tried, unsuccessfully, to cross it during more temperate months in their 2004 motorbike documentary Long Way Round). The road is mostly used by truckers bringing supplies to remote villages. They don’t turn off their engines for the duration of the two-week drive, and usually set out in pairs. Breaking down on the little-used road would mean almost certain death.
Other travel options are by aircraft or via a 1,000-mile boat ride up the Lena River during a brief window in the summer months when the river isn’t choked by ice floes.
Because of this limited accessibility, Russian pharma companies have great difficulty transporting anything to the region. Yakutsk, along with the many villages and settlements to the north and east, are literally cut off from the rest of the world. The only effective means of transport is by air. Transportation of nearly all drug product is therefore done by plane with the use of thermal boxes.
Traditionally most of the transportation to Yakutia goes through Moscow. The standard time of transportation with all preparatory steps included is around 48 hours, out of which eight hours account for flight time. During transportation, goods are exposed to many different temperatures, from mild at their departure point — +5° to +10° C — to extreme temperatures at their destination, reaching -40° C or even -50° C.
According to Andrey, there is a staggeringly high incidence of temperature abuse and approximately 80% of all shipments to the region result in exposures to unacceptably low temperatures. The 20% of shipments that indicate no exposure to unacceptable temperature extremes come as a result well-coordinated effort by the sender and the receiver as well as quality preparatory work preceding deliveries.
"Our investigations show that most of the mistakes are made by the sender of the goods. Such mistakes are due to the lack of knowledge and indifference — which is the standard approach to the delivery of such medicines," Andrey explained. "For example, when packaging the goods, an ordinary number of cold packs is used no matter to which region the goods are being shipped, with no account, for instance, that the temperatures in Yakutia are severely low. In addition to that, the problem is that good distribution practices are not applied. When the terms and the obligations for the agents of transportation are not defined properly, the transportation cannot be done efficiently." His exasperation was palpable.
Recently, there was an outbreak of measles in the city of Yakutsk and the populace desperately needed a shipment of vaccine. Transportation was prepared by one of the leading Russian pharmaceutical companies. The vaccine, which cannot be frozen lest it be rendered totally ineffective, was registered for delivery by aircraft with a direct flight from Moscow to Yakutsk. Bad weather conditions forced the aircraft to land in another city in Siberia. The company personnel had to negotiate with another airline to arrange for the vaccine to be collected from where it was left by the initial carrier and was to be sent once again to Yakutsk. The second attempt also failed due to adverse weather and landed in yet another Siberian city.
After two more failed attempts, they were able to finally accomplish the delivery by chartering a helicopter. Yet the long-suffering vaccine spent nearly two weeks changing different Siberian cities and aircraft yet it never reached Yakutsk. Knowing the vaccine’s fragility in freezing temperatures, the sender finally decided not to take the risk of delivering suspected damaged vaccine and had it sent back. When the vaccine returned to Moscow, it was carefully tested by the sender. To everyone’s astonishment, the vaccine remained perfectly stable; its required temperature regime was never broken.
After an internal investigation it was found that the personnel of the pharmaceutical company both in Moscow and in the company’s offices in Siberia managed to take all possible measures to keep the delivery from exposure to frozen temperatures. At all stages of transportation the personnel communicated with the airports and warehouses in Siberia to take care of the vaccine and to ensure that the required cold chain was observed.
Andrey concluded, "This delivery has become an example in Russia of a dedicated job well done and a successful result reached, no matter what the obstacles were. Such an example proves that the cold chain can be properly ensured even in Siberia, as long as the personnel remain attentive and accurate to what they do."
Keep fighting the good fight, Andrey Kukharenko.
First published on ClutchCargo.us
Promoting Good Practices for Temperature-Sensitive Healthcare Products
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About Kevin O'Donnell
Kevin O’Donnell is Senior Partner at Exelsius Cold Chain Management Consultancy US, an international provider of consultative, research and training services to manufacturers, airlines, forwarders and other stakeholders in the life science logistics sector. Mr. O’Donnell’s prior positions include: Director & Chief Technical Advisor at ThermoSafe Brands, and Principle Packaging Engineer at Abbott Laboratories Global Pharmaceutical Division, from where he retired in 2005 after a 26-year career. He is widely considered a principal architect of the modern-day cold-chain movement and is internationally respected throughout industry as an advocate, author, blogger, educator, training developer, and champion of good distribution and logistics practices for temperature-sensitive drugs. www.exelsius.co.uk