The Latest COVID-19 Resources and Updates

Photo Credit: James Gathany, CDC

Updated May 19, 2020

Stirling Ultracold has always felt a strong sense of pride and responsibility by helping laboratories, biorepositories, hospitals and test/research facilities further their research and bring life-saving and life-changing solutions to patients.

This has never been more of a priority than it is right now. As a High Containment Program Director at a university recently told us…

“We decided to purchase a new freezer for these COVID-19 projects so that we would be able to keep the Select Agent freezer locked up and inaccessible to the new personnel. I very much appreciate that Stirling was able to accommodate us and make it possible for a quick purchase of this new freezer.”

During the COVID-19 outbreak, we are actively monitoring the rapidly evolving needs of our health care infrastructure. The following updates and resources can help you address the urgency of this pandemic.

CDC guidelines for specimen handling

The CDC has provided guidance on specimen collection, storage and shipping. For specimens stored at 2–8°C, all laboratory testing must occur within 72 hours of collection. If a delay in processing or shipping is expected, store specimens at -70°C or below. For more information, review the CDC’s Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019.

VWR’s Virus Detection: COVID-19 research-approved equipment protocol

VWR scientists are engaged with the supplier and research communities to provide a protocol for the research use-only identification of COVID-19. This protocol closely mirrors that of the CDC-recommended protocol and, in some cases, makes use of the materials already validated by the CDC.1 For more information, please review VWR’s COVID-19 Virus Detection protocol/product list, which includes Stirling Ultracold’s SU780XLE upright ultra-low freezer.

Easing the COVID-19 testing backlog

The availability of more COVID-19 tests likely will create backlogs and delays as research organizations scramble to store more biological samples. We are ready to help those testing sites and diagnostic laboratories that must rapidly increase ultra-low temperature (ULT) storage capacity to meet surging demands. Our upright, undercounter and portable ULTs can help you increase sample capacity quickly and meet the CDC’s -70°C storage requirements, whether in the lab or at a remote, off-site testing location. Find out more about our ULT storage solutions.

Expedited delivery of our ULT freezers 

We are committed to getting you the vital supplies you need as soon as possible. Despite the disruption to many industries, our business and supply chain are still currently operating on schedule. At this time, we can expedite new orders in as quickly as one week. Although we have not been impacted by major upstream disruptions to our supply chain, the situation remains fluid; we will continue to work diligently with our suppliers to maintain factory schedules.

With our unique free-piston Stirling engine technology, our ULT freezer products are lightweight and compact relative to storage capacity, offer a flexible voltage range (including the ability to plug into 110V outlets), have the widest temperature setpoint range, and provide the flexibility for remote and rapid deployment of ULT storage. View and download our new Guide to Rapid and Remote Deployment of Ultra-Low Temperature (ULT) Storage for more information.

CDC health and safety guidelines

Like many, we’ve incorporated the CDC’s health and safety guidelines into our everyday business. This includes the voluntary option to telecommute for all employees not essential to manufacturing, additional cleaning and disinfecting activities, and disinfecting all incoming freight.

 

We’re working in close collaboration with our partners to support and expedite COVID-19 testing and vaccine research. If you have any questions about the rapid or remote deployment of ULT freezer products, please don’t hesitate to reach out to us at 1-855-274-7900 or contact us here.

Source

1 https://us.vwr.com/cms/covid_19_virus_detection

The ULT25NEU with SenseAnywhere:
A Complete Solution for Clinical ULT Applications

By Jennifer Shrider, Marketing Coordinator

The Stirling Ultracold ULT25NEU is the only portable and deployable ultra-low temperature (ULT) freezer on the market for the clinical storage of temperature-sensitive drugs and treatments. Now it’s simpler than ever to ensure the viability of therapies collected at remote clinical sites with the new ULT25NEU and the SenseAnywhere wireless temperature monitoring system. This system makes it easy and affordable to monitor the temperatures of samples from any location and on any device with a browser through a secure Cloud.

The ULT25 equipped with SenseAnywhere provides a reliable cold storage solution close to the patient, while also allowing treatment providers and clinical trial managers to monitor and audit the safe storage of valuable medications and therapies from afar. This is ideal for providers of regenerative, cellular, genetic and immuno therapies who need to validate the viability of temperature-sensitive treatments at multiple remote clinical locations. With the addition of the SenseAnywhere system, you can establish and centrally maintain an audit trail of sample temperature data for a remote fleet of ULT25 freezers at hospitals, surgery centers and clinical trial sites. SenseAnywhere is FDA compliant to 21 CFR Part 11 for data integrity as well as meeting the EN 12830:2018 standard for temperature recorders for transport, storage and distribution of temperature-sensitive goods.

The key features of the SenseAnywhere system include:

• Accurate freezer temperature monitoring with a multi-point calibrated RTD probe, including ambient temperature conditions around the freezer

• Customizable instant alarms will notify you via email and/or text when limits are surpassed

• Historical and real-time 24/7 data available to track for compliance

• Secure data storage with access anytime and anywhere via a secure Cloud

SenseAnywhere’s AiroSensor model

There are many additional benefits of the SenseAnywhere system such as having no software to install (connect via an AccessPoint and site Ethernet, or cellular data), no backups required and no maintenance. It’s waterproof and the battery life is guaranteed for 10 years. Once you register online at the SenseAnywhere client portal you can manage the settings of your connected device, view graphs, set alarm profiles and schedule/download reports.

The ULT25, equipped with the SenseAnywhere system, is the complete ULT solution for clinical point-of-use storage, patient drug delivery and the remote collection of samples, all while having secure temperature monitoring throughout the process. Exceptional sample safety and data tracking have never been so effortless to maintain until now.

To learn more about the portable ULT25NEU freezer, download the brochure »

Shuttle Freezer Delivers Unique Cancer Treatment Solution

By Jennifer Shrider, Marketing Coordinator

Stirling Ultracold’s ULT-25NE Shuttle™ freezer is the only portable, deployable solution available today that can bring your ultra-low temperature (ULT) storage directly to the patient. The Shuttle freezer is ideal for clinical trials, biologic drug and immunotherapy delivery because it is small, energy-efficient and plugs into any outlet or DC power from an automobile adapter. This ULT freezer will keep injectable biologic drugs safe due to the reliability of the free-piston Stirling engine. 

Biotechnology company, Amgen Inc., has developed the first and only FDA-approved oncolytic viral therapy called IMLYGIC®, which treats melanoma skin cancer lesions that have returned after surgery. Frozen IMLYGIC® vials require a transport and storage temperature range of -90°C to -70°C. IMLYGIC® must be stored in the carton and protected from light until ready to use.

Amgen is utilizing the Shuttle freezer to store IMLYGIC® in a clinical environment. The Shuttle freezer is an ideal storage solution for clinicians, hospitals and treatment centers because it is lightweight and easily maneuverable. To view a video that explains the storage and handling of IMLYGIC®, and features the Shuttle freezer starting about 5 minutes into the program, check out the webpage link here.

Shuttle freezer in the IMLYGIC® video at 6:52

It’s inspiring to see our ultra-low freezer being used on the front lines of fighting disease and improving the lives of cancer patients every day. 

IMLYGIC® is a trademark of Biovex, Inc., a subsidiary of Amgen, Inc.

 

The Shuttle: Bringing ULT Storage to the Patient

For those of you that have been following our blog, you know that we’ve posted a lot about our SU780XLE Upright ultra-low temperature freezer. Perhaps you’re not aware that Stirling Ultracold also manufacturers two smaller ULT freezers. In this post, I’m going to share information about one of those products called the ULT-25NE, or Shuttle™, which offers a portable, reliable, and energy-efficient way to store and deliver samples.

With today’s advancements in pharma and biotech research, we understand the need to keep biological materials at ultra-low temperatures for Clinical Research Organizations (CROs) and delivery of injectable biologic drugs. The Shuttle is the only portable solution available today for bringing ULT storage to the patient, making it ideal for clinical trials and drug delivery. The Shuttle is a small, lightweight, and efficient ULT freezer, maintaining temperatures as low as -86°C and up to -20°C.  Although the ULT freezer is small, it features the superior reliability of our free-piston Stirling engine.

The Shuttle provides a unique solution for any organization that needs to store samples and/or drugs either for collection or delivery. With the importance of your samples and drugs in mind, we designed this small, lightweight, transportable ULT freezer. The Shuttle is the best ULT technology for making sure that your samples are safe in remote locations.

Clinical Trials & Drug Delivery Problem Solver

Due to its small size and light weight, the Shuttle can be inexpensively transported to anywhere in the world, making it ideal for remote specimen collection and drug delivery. The ability to easily ship the Shuttle anywhere in the world at low costs provides opportunities for many CROs to send ULT freezers to those in the field collecting samples that need to be stored at ultra-low temperatures. The need to store drugs at ultra-low temperatures in clinical trials is another area where Stirling Ultracold’s Shuttle provides unique and desirable features. The compact ULT freezer can even be plugged into a mobile power supply to transport between different site locations.

The Shuttle’s Unique Features Include:

  • It weighs only 46 lbs. (empty), making it easy to carry and ship at the lowest cost.
  • The freezer chamber is protected by two lids and a lid latch, which ensures that your samples will remain at the desired temperature set point.
  • An LED control panel monitors and sets internal temperatures, as well as other operating and diagnostic controls features.
  • The AC and DC power connections plug into any outlet, worldwide (110V to 240V), or a 12V DC mobile power supply.
  • It safely stores up to 18 standard 2” boxes.
  • Like other Stirling Ultracold ULT freezers, The Shuttle uses 100% natural refrigerants, with the industry’s lowest energy consumption of less than 2.8 kWh/day (-80°C).

The Shuttle is the ideal solution for bringing ULT storage to the patient, whether gathering and storing specimens for clinical trials in remote locations or delivering biologic drugs to patients anywhere in the world.

Although it may be small in size, the Shuttle portable ULT freezer can have a large impact on your research program. If there are people in your organization involved in clinical trials or drug delivery, they may appreciate it if you pass this post onto them.