Cold Chain - States are panic buying powerful deep freezers to store the COVID vaccine at -94F

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trader32176
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Re: Cold Chain - States are panic buying powerful deep freezers to store the COVID vaccine at -94F

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Coronavirus digest: Cold chain doubts delay vaccine distribution

12/28/20


https://www.dw.com/en/coronavirus-diges ... a-56071203


Germany’s coronavirus vaccination plans hit a snag after temperature trackers showed that some BioNTech-Pfizer shots may not have been kept cold enough. All the latest with DW.

Several German cities experienced delays in receiving and administering coronavirus vaccinations after several temperature trackers showed that some BioNTech-Pfizer shots may not have been cold enough due to inconsistencies in the cold chain.

"When reading the temperature loggers that were enclosed in the cool boxes, doubts arose about the compliance with the cold chain requirements," Bavaria’s district of Lichtenfels said in a statement.

The BioNTech-Pfizer vaccine uses the mRNA technology and needs to be stored at nearly -70 degrees Celsius (-112°F) before being shipped in cool boxes filled with dry ice. Once out from the ultra-low temperatures, the vaccine must be kept at 2°C to 8°C to remain effective for up to five days.

The temperature in one cool box had risen to 15°C during transport, a spokesman for Lichtenfels said. About 1,000 shots were affected. He added that they had not received any communication from BioNtech on how to proceed.

Lichtenfels, as well as Bavaria’s districts of Coburg, Kronach, Kulmbach, Hof, Bayreuth and Wunsiedel were waiting to understand if the shots could still be used.

In a statement, BioNtech said the company was responsible for shipping vaccines to the 25 German distribution centres, after which federal states and local authorities would handle the shipment to vaccination centers as well as mobile vaccination teams.
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TimGDixon
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Re: Cold Chain - States are panic buying powerful deep freezers to store the COVID vaccine at -94F

Post by TimGDixon »

Its just crazy - the universities throughout california have plenty of capacity to hold the vaccines... and so should most states
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Re: Cold Chain - States are panic buying powerful deep freezers to store the COVID vaccine at -94F

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Some 500 Coronavirus Vaccine Doses Intentionally Destroyed, Hospital Says

December 30, 2020


https://www.npr.org/2020/12/30/95173616 ... pital-says


A now former employee at a Wisconsin medical center "intentionally removed" 57 vials of a coronavirus vaccine from refrigeration, forcing officials to throw out nearly 500 doses, according to an internal investigation.

Aurora Medical Center officials had initially suspected the Moderna vaccines, which must be kept between 36° to 46°F, had inadvertently been left out at the Grafton hospital on Dec. 26. But an investigation found the individual "acknowledged that they intentionally removed the vaccine from refrigeration," officials said Wednesday.

The medical center, which is part of Advocate Aurora Health Care, has notified "appropriate authorities for further investigation" and added that the individual is no longer employed by Aurora.

"We continue to believe that vaccination is our way out of the pandemic. We are more than disappointed that this individual's actions will result in a delay of more than 500 people receiving their vaccine. This was a violation of our core values."

The vials can remain at room temperature for up to 12 hours. That allowed clinicians to salvage some of the doses.

As of Wednesday afternoon Aurora Health Care said more than 21,000 health care workers had received the first of two injections at the company's centers.

A total of 47,157 of coronavirus vaccines have been administered in Wisconsin since vaccinations began over the last two weeks, according to state data.
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Re: Cold Chain - States are panic buying powerful deep freezers to store the COVID vaccine at -94F

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Thermo King launches mobile reefer containers with autonomous operation

12/21/20


https://www.globalcoldchainnews.com/the ... operation/


ColdCube containers allow non-refrigerated vehicles to handle pharma, retail, catering and last mile deliveries.

ColdCube Connect Flex have a battery giving at least 12 hours of autonomous cooling capacity, independent from the vehicle battery.

“The containers allow customers to ensure an autonomous temperature controlled environment in non-refrigerated vehicles and fulfill a variety of transport and storage needs including Pharma, retail, catering and last mile deliveries, ” Thermo King says.

Bluetooth connection enables customers to wirelessly control the temperature set-point and provides visibility of temperature and status without opening the container,

The containers come with s temperature sensor

“ColdCube containers provide a simple and flexible way to ensure that Pharma, fresh or catering temperature-sensitive products are moved and stored in the right, controlled environment,” said Oscar Sanz de Acedo Pollan, aftermarket engineering leader at Thermo King.”

The new Flex models, thanks to the integrated battery and autonomous operations, give customers even more flexibility. They can now store the container outside the vehicle whenever needed, without looking for an external power source to connect to.”

ColdCube pharma certified models have temperature ranges from -30 degrees Celsius to +30 degrees Celsius depending on the version, and internal ventilation.

The ColdCube Connect containers are available in 140, 330 and 720L versions, Bluetooth connected and telematics ready.
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Re: Cold Chain - States are panic buying powerful deep freezers to store the COVID vaccine at -94F

Post by trader32176 »

Is Cold Transport Possible with Drones?

https://www.redwoodlogistics.com/is-col ... th-drones/


It appears the US FAA is seeing the light with regards to the idea of delivering products to consumers via drones.

A recent regulatory approval in the South Eastern United States has finally set a new milestone in the history of drone technology. These new regulations will allow a select few operators to actively compete to be the first to achieve perfect line-of-sight delivery of commodities to customers by drones.

If successful, they may see their delivery radius expand up to 30 miles.

This is still a test in progress and likely has years to go before becoming a reality. However, adopting drone technology to enhance supply chain operations is closer than it’s ever been.

In several European countries, the delivery of many dry goods via drones has been a possibility for roughly two years now. And China has had rural drone deliveries since 2015. In fact, there are a total of 27 countries around the globe that have drone trials or active programs already delivering packages.

But there is still one thing that this delivery method is missing; the ability to deliver refrigerated goods.

Cold delivery drones would be a huge achievement for the industry and a step in the next, most logical direction. Being able to expedite the delivery of everything from life-saving medicines to fresh sandwiches made at your local deli would be absolutely revolutionary.

But, is it possible?

What are the Benefits of Drone Delivery of Cold Storage Products?

Cold storage shipping is already a bit of a challenge for most smaller supply chains. The main issue usually being the fact that the temperature in the reefer container must be kept within a specific range. And if achieving this in a full-sized container can be relatively difficult, doing it with a drone is bound to be twice as hard.

If the drone industry can find a way to keep items outside their ‘danger-zone’ temperature range, the benefits could be quite significant.

Here are a few general benefits that cold transport drones could offer a supply chain…

Quicker delivery of smaller items

A drone can fly very quickly. Some of the fastest on the market can travel at almost 70 mph at low altitudes.

Since they are compact, they could potentially deliver smaller cold package from a facility to a customer within 20 miles in a matter of minutes.


Save money on deliveries

Drones are built to be efficient, using electric-powered engines that consume very little energy to operate. The durability and reduced maintenance costs of drone shipping can help save transportation companies a large amount of money annually.


Sustainability


These battery-operated flying machines produce zero emissions. This is great for our environment as it reduces the carbon footprint and contributes to the global push for greener supply chains.

Perfect for the medical industry

Most critical medications and vaccines must be kept within a specific temperature range to retain potency.

The major hurdle in healthcare is finding a way to reduce the time and resources needed for delivering them. However, the Journal of the Society of Laparoendoscopic Surgeons (JSLS) has covered this more in detail in this comprehensive overview.


Cold transport drones can deliver to remote, hard to access areas

In times of war, environmental or weather-related disasters, a cold transport drone system can fly unobstructed and deliver medical supplies. Likewise, it could even get food out to first responders or patients onsite.

Cold transport drones would be helpful in delivering life-saving vaccines in areas that have an outbreak or epidemic while reducing the potential of exposure to humans.

What are the Challenges to Implementing Cold Storage Delivery with Drones?

While these benefits look great on paper, there are still some challenges that exist with making this concept a reality…


FAA Regulations

As of October 2019, the Federal Aviation Administration restricts the operation of drones to outlying areas, with flight paths not directly over large civilian populations, and only within a direct line of sight. This means that the operator must be able to visually locate the drone as it flies – which dramatically reduces the range. If drone delivery is going to be practical, these regulations must be revised.


Safety


While most of these regulations seem obtuse, they are active due to public safety. Drone technology introduces several potential threats, including in-air malfunctions, loss of signal from the operator, and even possible terrorism threats. Until mitigated, regulations on operations will continue.

Creating Lightweight Cold Storage

With flight comes weight restrictions. While drones are built with lightweight materials, this comes with the reality of weight capacity. Cold product shipping must maintain the desired temperature level at all times. However, this will add weight to the equipment and reduce the amounts of products available to fly.


Final Thoughts

The concept of cold storage drone operation is enlightening and promising.

However, there are several issues that must be resolved first to ensure this new delivery concept is safe and efficient. Testing over the next few years along with partnerships with global drone manufacturers should narrow this window a bit. All in the hopes of making cold storage drone delivery a practical option sooner than later.
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Re: Cold Chain - States are panic buying powerful deep freezers to store the COVID vaccine at -94F

Post by trader32176 »

Refrigerated Drones Could Carry Blood and Vaccines

posting.php?mode=reply&f=2&t=354

1/23/17

(Lets go back 4 years.)


Researchers at Johns Hopkins Medicine have developed refrigerated drones that could safely transport medical supplies such as blood, medications, and vaccines.

Dr. Timothy Amukele, a pathologist and researcher with a special interest in solving healthcare issues in remote areas of the globe, has perfected a system of cooling on drones which can keep blood carried in specially refrigerated coolers at the correct temperature during drone delivery.

The Post Bulletin reports that successful test flights had a duration of about 26 minutes and traveled 12 miles. Solving the problem of refrigeration makes the use of drones to delivery blood supplies or other medical equipment more realistic. Drone delivery is already used in Rwanda by drone company Zipline to fly medical supplies to remote clinics; Zipline and Flirtey have tested drone delivery for medical supplies in the US.

Researchers at Johns Hopkins published an article last summer on findings that the use of drone delivery in developing countries could increase vaccination rates.

The study, originally published in the journal Vaccine, says that drones provide a very significant cost savings over land-based transportation, which is often limited by terrain, road conditions, and cost-prohibitve fuel and maintenance on land-based vehicles.

“Many low- and middle-income countries are struggling to get lifesaving vaccines to people to keep them from getting sick or dying from preventable diseases,” says senior author Bruce Y. Lee, MD, MBA, an associate professor at the Bloomberg School and director of operations research at its International Vaccine Access Center. “You make all these vaccines but they’re of no value if we don’t get them to the people who need them. So there is an urgent need to find new, cost-effective ways to do this.”

Amukele’s research on drone refrigeration systems may make drone delivery of vaccines – and other medical supplies requiring temperature control – more immediately practical, saving lives across the globe.
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Re: Cold Chain - States are panic buying powerful deep freezers to store the COVID vaccine at -94F

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PCS Engineers Innovative Cold Chain Platform for Transport of COVID-19 Vaccines Across Multiple Modes of Transport from Drones to Planes to Trucks

Enhancing Cold Chain Reliability with the Apollo™ Platform

11/18/20


https://www.prnewswire.com/news-release ... 76041.html


ASHEBORO, N.C., Nov. 18, 2020 /PRNewswire/ -- As COVID-19 vaccines prepare to launch, drug makers are wrestling with the unprecedented scale and complexity of setting up supply chain and distribution of vaccines from the manufacturing plant to the clinic, for the entire world. Central to this logistics challenge is the necessity to maintain the vaccines within specific temperature ranges for protecting vaccine efficacy, with some vaccines requiring temperatures as low as -75⁰C.

Today, Phase Change Solutions (PCS) has an answer.

To accommodate the wide range of temperature requirements of various vaccine manufacturers and logistics companies, PCS has developed a versatile platform of BioPCM® phase change material solutions that support a range of temperatures from -75°C to 25°C for pharmaceutical and coldchain applications. Designed to maximize safe shipment time periods, Apollo™ optimizes energy usage in supply chain infrastructure from the manufacturer to the consumer. Apollo™ uses smart nesting of BioPCM® solutions in combination with other components, such as insulated shippers, to enable modular and robust solutions. For vaccines packaged by the manufacturers according to strict FDA and other regulations, the Apollo™ platform ensures risk mitigation from the manufacturer to the vaccine recipient and provides standardization of temperature control across the entire supply chain.

"Millions of packages have been safely shipped using BioPCM®, the family of phase change materials that was invented at PCS," said Dr. Reyad Sawafta, Chief Scientific Officer of PCS. "Previously, we had developed BioPCM® materials that could support temperatures as low as -50°C. Recently, we engineered a novel class of BioPCM® materials that could operate at lower temperatures, down to -75°C or beyond, to address the urgent requirements of some potential vaccines being considered for COVID-19."

In addition to a wide temperature range, the Apollo™ platform accommodates a range of payload sizes and shapes, and varying shipment durations, for any cold chain situation. Another key feature of the Apollo™ platform is that it can be scaled for insulated shipping across multiple modes of transport from drones to planes, thus ensuring that vaccine efficacy is maintained globally with competitive operating costs for platform integrators, logistics providers and pharmaceutical companies. Additionally, Apollo™ offers the possibility of reducing or completely eliminating the need for dry ice in cold chain packages, which can significantly increase the number of packages that can be safely shipped by air, while reducing environmental impact.

"We knew our pharmaceutical partners would depend on us to come through quickly with a solution to provide standardization of temperature control across their supply chain. As a leader in enabling cold chain transportation and storage, we are proud to enable our partners to deliver COVID-19 vaccines intact, to any place in the world where the vaccine will be administered," said Govi Rao, CEO of Phase Change Solutions (PCS).
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Re: Cold Chain - States are panic buying powerful deep freezers to store the COVID vaccine at -94F

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Volansi Partners with Merck to Deliver Cold Chain Meds in N.C.

11/3/20


https://insideunmannedsystems.com/volan ... ds-in-n-c/


Volansi recently completed the first successful drone delivery of temperature-controlled medicines within the U.S.

The deliveries, which took place in North Carolina in September, represent phase one of a project with Merck and Vidant, and is what Volansi CEO and Co-Founder Hannan Parvizian describes as “an important first step toward redefining the biopharmaceutical supply chain of the future.”

The VOLY C10 UAS transported cold chain medicines from Merck’s Wilson, North Carolina, manufacturing site to a Vidant Health clinic. Deliveries between these locations will be ongoing.

“The goal of the project is to better understand how drones can be used to improve access to health care—a critical issue in eastern North Carolina, where the project is taking place,” Parvizian said. “The largely rural area is home to 1.4 million people, with many living miles from the nearest pharmacy or clinic. For those suffering from diseases or chronic conditions, having a supply chain that works for them isn’t just about convenience—it’s a matter of life or death.”

The Aircraft

The all-electric vertical take-off and landing (VTOL) VOLY C10 was designed to deliver this type of sensitive cargo, Parvizian said. Rather than dropping it by parachute or lowering a rope, which has its risks, the UAS lands like a helicopter at the delivery location. Then, a “soft touch” system automatically releases the cargo from the drone.

The UAS requires minimal infrastructure to operate, Parvizian said, and can transport 10 pounds of fragile cargo up to 50 miles.

“There is less risk to our cargo than other transportation methods because the delivery is made immediately upon receiving the shipment and taken directly to the delivery point (as opposed to being sent to a centralized distribution center and then onward via plane, truck, etc.),” Parvizian said. “Furthermore, drones can streamline such logistical tasks as order confirmation by delivering temperature trackers and shipping confirmations on the return flight.”

Challenges and Next Steps

Airspace access is one of the biggest challenges for this type of application, Parvizian said, which is why Volansi is working closely with the FAA’s Unmanned Aircraft System Integration Pilot Program (IPP) and the North Carolina Department of Transportation. These collaborations help ensure deliveries are made safely and in line with state and federal guidelines.

For phase two and three of the project, Parvizian hopes to receive approvals from the FAA to operate in other locations, enabling a “flexible, on-demand, and responsive supply of critical medicines.”

Volansi is taking a “crawl, walk, run approach” to these deliveries, Parvizian said, with the goal of opening up more opportunities in the future. For example, the VOLY C10 drone now making deliveries has a 10-pound payload capacity. In future phases, the company would like to scale up to its larger VOLY C20, which can carry a heavier load.

“For this to happen, the U.S. must first open its national airspace more widely to drone flights,” Parvizian said. “Once we have the right regulations in place, we could potentially deliver hundreds of pounds or more on a daily basis and to multiple locations far and wide.”

And while for now the VOLY C10 is carrying Merck’s vaccines against measles, mumps, rubella, chickenpox, pneumonia, and hepatitis, that can be expanded to other vaccines and cargo as well.

Strengthening the Supply Chain

This isn’t the first time Merck and Volansi have collaborated, Parvizian said. The companies helped deliver temperature-sensitive medicines in the Bahamas and Puerto Rico after hurricanes Maria and Florence. These demonstrations “foreshadowed how we intend to redefine the biopharmaceutical supply chain of the future,” Parvizian said.

“As a health care leader, Merck is very supportive of collaborations using new technologies to explore how one day we could help better serve the health care community,” Merck’s Senior Vice President, Global Supply Chain Management Craig Kennedy said, according to a news release about the deliveries. “Our existing distribution system is strong, and this pilot helps us explore new innovative delivery options that would complement our existing supply chain capabilities.”
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Re: Cold Chain - States are panic buying powerful deep freezers to store the COVID vaccine at -94F

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Pfizer vaccine doesn’t need ultra-cold storage after all, company says

2/19/21


https://arstechnica.com/science/2021/02 ... -required/


In a bit of good news, Pfizer and BioNTech announced today that their highly effective COVID-19 vaccine does not require ultra-cold storage conditions after all and can be kept stable at standard freezer temperatures for two weeks.

The companies have submitted data to the US Food and Drug Administration demonstrating the warmer stability in a bid for regulatory approval to relax storage requirements and labeling for the vaccine.

If the FDA greenlights the change, the warmer storage conditions could dramatically ease vaccine distribution, allowing doses to be sent to non-specialized vaccine administration sites. The change would also make it much easier to distribute the vaccine to low-income countries.

“We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the US and around the world,” Pfizer CEO Albert Bourla said in a statement. “If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.”

Balmy future


Currently, the vaccine is labeled as requiring storage between -80°C and -60°C (-112°F to ‑76°F) for up to six months. But it can also be refrigerated for up to five days at standard refrigerator temperature (2⁰C and 8⁰C (36⁰F and 46⁰F)). The ultra-cold requirement cooled enthusiasm for the vaccine when the FDA first granted it emergency authorization for use. Only specialized facilities, such as hospitals and research labs, tend to have freezers equipped to maintain such cold temperatures, raising concerns about how easy it would be to get the vaccine into people’s arms.

Prior to the vaccine’s rollout, Pfizer and BioNTech tried to ease those anxieties, emphasizing their expertise and existing cold-chain infrastructure. The two companies developed specially designed, temperature-controlled thermal shippers filled with dry ice to maintain a temperature of -70°C ± 10°C. The containers included GPS-enabled thermal sensors to track the location and temperature of each vaccine shipment as they made their way to distribution sites. Vaccine doses could be kept in the thermal containers for up to 30 days if the dry ice was refilled every five days.

If approved, the new storage conditions would allow the vaccine to be kept at a mere -25°C to -15°C (-13°F to 5°F)—a temperature range any standard freezer can handle—for up to two weeks. And the vaccine doses can then be kept at standard refrigerator temperatures of 2⁰C to 8⁰C for five days on top of that.

The companies report that as they continue testing the limits of the vaccine, they expect the expiration dates could be extended as well.
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Re: Cold Chain - States are panic buying powerful deep freezers to store the COVID vaccine at -94F

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Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

Update Provides Alternative Temperature for Transportation and Temporary Storage for Frozen Vials Before Dilution

2/25/21


https://www.fda.gov/news-events/press-a ... ons-pfizer


Today, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). The change is being reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers).

“Pfizer submitted data to the FDA to support this alternative temperature for transportation and storage. This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions. The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

Pfizer Inc. submitted data to the FDA to demonstrate that their COVID-19 vaccine remains stable after storage of the undiluted vials for up to two weeks at standard freezer temperature. The alternative temperature for storage of frozen vials is not applicable to the storage of thawed vials before dilution (which can be held in the refrigerator for up to 5 days), or on the storage of thawed vials after dilution (which can be held at refrigerator temperature or room temperature for use within 6 hours).

The updated Fact Sheets for Health Care Providers Administering Vaccine (Vaccination Providers) are intended to help frontline workers understand the new alternative transportation and storage temperatures. The Fact Sheets are available on the FDA website.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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