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  1. Tapas Sadasivan Nair
  2. Cold chain equipment
  3. Friday, 17 June 2016

Most ice-lined refrigerators in India are fully functional at 5 - 45 degrees Celsius (ie, they are able to maintain an internal temperature of 2-8 degrees Celsius when the external temperatures are between 5 and 45 degrees Celsius). Some states of India have an extremely cold climate during winters (for example, the areas of Jammu and Kashmir, Uttarakhand, Sikkim that are in the Himalayas) and so they are prone to high rates of vaccine freezing.


I am sure this is a problem experienced by program managers of Russia, Canada, Greenland, Iceland, northern Europe, Alaska, etc and would be extremely grateful if they could share how they have managed to tackle this in their respective countries/regions.


The only resource that I have been able to find till now after an extensive search is "The Warm Chain", which suggests the use of a low ambient temperature refrigerature which provides protection upto -5 degrees Celsius.Does WHO have any guidelines regarding this?


A related question would be - how do we arrange for outreach immunization in such cold climates? What sort of ice packs should be used in such a scenario?


Warm Regards,


Dr. Tapas Sadasivan Nair


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Sophie Newland Accepted Answer

Would like to flag as a resource the WHO Vaccine Management Handbook (VMH) module (2015) on how to use of passive containers for transport and outreach - it includes some guidance on how to ensure sufficient warm life for supply routes. This module is available on the WHO website and in the TechNet Resource Library (TRL).

http://www.technet-21.org/library/1235-how-to-use-passive-containers-and-coolant-packs-for-vaccine-transport-and-outreach-operations

http://apps.who.int/iris/bitstream/10665/183584/1/WHO_IVB_15.03_eng.pdf

References
  1. http://apps.who.int/iris/bitstream/10665/183584/1/WHO_IVB_15.03_eng.pdf
  2. http://www.technet-21.org/library/1235-how-to-use-passive-containers-and-coolant-packs-for-vaccine-transport-and-outreach-operations
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  1. more than a month ago
  2. Cold chain equipment
  3. # 1
Andrey Kukharenko Accepted Answer

Dear Chris, Dr Nair and others,

Couple of years ago, I've asked Mr. Bruce McCormick from SAVSU to make a tests of PHD 7X solution in cold environment (at -20C). Results was very nice (see attached) upto 25 hours performance.

In our experience:

PPU boxes can hold temperature not more 15 hours with warm-packs at -20C environment

EPS-XPS boxescan hold temperature not more 13 hours with warm-packs at -20Cenvironment

Regarding storage of vaccines in Fridges - solution can be only one - heating (warming) of storage environment! We cannot beat the Phisics, it will be frosen anyway! Of course with better insulation it will takes a little bit more time than poor one.

There is also can be an option - using geothermal heat. But in this case, storage rooms should be built deep underground, where temperature is around +5C. And, unfortunately, it is not applied in permafrost regions.

Regards,

Andrey

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  1. more than a month ago
  2. Cold chain equipment
  3. # 2
Chris Morgan Accepted Answer

Hi again Dr Nair and others, I'd like to suggest a couple of other thoughts:

1) I wonder if there is any recent application of new technologies in insulating materials or refrigeration engineering that have been applied specifically to very cold climates. Some recommendations I've seen simply suggest that refrigerators be placed in warm rooms, which may not always be practical. Others better informed than me may have information on newer cold chain technologies applied to this problem.

2) WHO guidance on avoiding freeze damage, in various documents, does give some consideration to cold climates, including advice on use of good temperature monitoring and freeze indicators, with careful attention to the temperature of water/ice packs, including warm packs in some instances

3)Robert Steinglass has kindly shared an old report by Alan Bass and other distinguished colleagues - from 1996 - on some analysis of the 'warm chain' needs of cold climates and TechNet discussion of this included some consideration of out of cold chain usage in certain situations. I haven't found any formal update this type of analysis and I'd emphasis that this report, and the ideas around out of cold chain may not represent current national or regional policy in many situations. I'm sharing the report because it did do some structured analysis of this issue, but please be cautious regarding the fact that it is from 20 years ago.

4) Lastly, from working in child health, I notice that even though the term 'warm chain' was coined by EPI in the 90s, it has since been co-opted by newborn care colleagues for use in describing the importance of keeping the newborn baby warm and supporting breast feeding...

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  1. more than a month ago
  2. Cold chain equipment
  3. # 3
Andrey Kukharenko Accepted Answer

Hi Guys!

I'm Russian, and yes - we are cold country. We have 5 different climate zones here, one of them - extremly special.

Once my teacher and friend Kevin O'Donnell ask me for my experience. Result is an article below, published in ContractPharma:

Welcome to Yakutsk! ... the Coldest City on Earth
Contributor: Kevin O'Donnell

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.

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  1. more than a month ago
  2. Cold chain equipment
  3. # 4
Sophie Newland Accepted Answer

Hello Dr. Nair, James, Joanie, Chris, Mogens, and fellow TechNet members,

I would like to contribute a link to an old (1995) but data-rich article: PROTECTING VACCINES FROM FREEZING IN EXTREMELY COLD ENVIRONMENTS (Source: P Carrasco, PAHO/WHO, Washington, DC; C Herrera, D Rancruel, M Rosillo, Universidad del Valle, Cali, Colombia.)

The article summarizes a presentation from the"Immunization in the 90’s: Challenges and Solutions" conference organized by the Laboratory Centre for Disease Control, Health Canada, October 5-7, 1994, Quebec City, please see page F-3 to review the study method and results.

To provoke your interest in this old literature, please find the discussion section pasted below.

Discussion.

These tests were carried out to provide health care workers with a set of guidelines to protect vaccines from freezing in extremely cold environments.

The test results confirm that health care workers can use the same vaccine carriers or cold boxes currently found in use, including ice packs that are above 10o C and below 24o C, to safely transport vaccines in extremely cold environments without freezing them.

However, caution should be taken because not all vaccine carriers or cold boxes will have a good "warm life" due to poor construction and low quality material. Using containers constructed with polyurethane insulation will provide the best protection for transporting vaccines and will guard them from freezing or from reaching internal temperatures above 10o C for a longer period of time.

The "warm life" performance for whatever type of insulated container is selected for the transportation of vaccines can be determined by simply following this procedure: use empty vaccine vials and load the container with non-frozen ice packs designed for it and place it outside in the cold air and monitor the amount of time required to completely freeze the packs. These data will provide all workers with a parameter for monitoring shipments in extremely cold environments. Ice packs can be stored either in a refrigerator or on a shelf in the same room where the vaccine load will be taken from the refrigerator and put into a container. The temperature of the room where the ice packs are stored should be below 24o C. The staff (including drivers) involved in the handling and transportation of vaccines in extremely cold environments must be alerted to change frozen ice packs with non-frozen ones.

In very cold environments, ice packs stabilized at an ambient temperature of ≤ 24o C can be used for the transportation of these vaccines for a period not exceeding 8 hours. The vaccines are very heat stable and the short time (< 8 hours) that they are subjected to temperatures between 10o to 24o C will not harm them.

http://publications.gc.ca/collections/Collection/H12-21-21-11E.pdf

References
  1. http://publications.gc.ca/collections/Collection/H12-21-21-11E.pdf
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  1. more than a month ago
  2. Cold chain equipment
  3. # 5
Mogens Munck Accepted Answer
20.6.2016

Dear Technet members,

Dr. Tapas Sadasirvan Nair is right in asking for guidelines about how to handle refrigerators at extremely low ambient temperatures.  I myself have had to face the problem in Kabul in the early 1970s working for FAO with animal vaccine kept in a walk-in cold room situated in a laboratory building without heating.  One morning we found our animal vaccine (like most human vaccines to be kept at 2-8-degrees C) completely frozen and completely damaged. 

You cannot avoid feeling a little stupid in such a situation 

My mischievous question now is: what would you do in a situation like this? Wait untill spring tremperatures for producing new vaccine?  Put a heater in the room where the walk-in cold room was installed?  Or perhaps even go to the extreme of putting the heater inside the cooling room?

Are there not technet members working in some of the cold regions mentioned by Dr. Nair who have had to face thjis problem? 

Best regards,

Mogens Munck 
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  1. more than a month ago
  2. Cold chain equipment
  3. # 6
James Cheyne Accepted Answer

My first experience with the cold chain was learning about how to keep vaccines warm in the cold climate of Greenland. Half way up the West coast there is the town of Jacobshaven that had a population of 2,000 people and their 3,000 dogs at the time. The district physician told me how he carried vaccine in the winter.

He made regular outreach trips with his dog team and sled to outlying settlements in temperatures of minus 30 and minus 40 C. He needed four or five layers of clothing to keep warm.

The temperature of the innermost layer was about +40 while he was on the move and the outermost temperature was about -40. He measured the temperature of each layer of clothing and figured out which pocket to use in his layers of clothing to keep the vaccine at the right temperature: temperature-controlled pockets.

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  1. more than a month ago
  2. Cold chain equipment
  3. # 7
Chris Morgan Accepted Answer

For outreach, I agree with Joanie - from my personal experience in Tibet Autonomous Region in the 1990s, one approach during winter was to transport in a vaccine carrier with "ice-packs" from fridge set to 8 degrees (which means they were actually cool water filled packs). Insulation of standard UNICEF vaccine carriers was sufficient to avoid cool down to freezing for most durations of outreach. I am not sure of how ice-lined fridges handle low temperatures - we did not have access to those at that time.

PS Anecdotally, our apartment kitchen in Shigatse was in an unheated part of the building and in coldest months it was sometimes necessary to put food into the (domestic electric powered) fridge to avoid it getting frozen if left on the bench. Our neighbours would hang raw food materials in a bag outside the kitchen window - it would stay frozen for three months, and they could just haul it in to cut off what they wanted when cooking.

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  1. more than a month ago
  2. Cold chain equipment
  3. # 8
Joanie Robertson Accepted Answer

Hi Dr. Nair,

My feedback is strictly theoretical, as I don't have any relevant experience to share on the storage aspect, but for outreach, if the objective is to maintain a temperature between 2 and 8 degrees C in conditions that are colder than that, the best way to prepare coolant packs would be to fill them with water that is at 8 deg C, and place them in a vaccine carrier with the vaccines. Depending on the insulation properties of the carrier, it will take some time for the water to cool down below 2 degrees, and until then the vaccines would be in the correct environment.

Joanie Robertson
PATH

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  1. more than a month ago
  2. Cold chain equipment
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