B Medical Systems, a global leader in medical cold chain solutions, has announced that the company’s Ultra-Low Freezer U201 has received the WHO PQS prequalification. This is the first-ever Ultra-Low Freezer in the world to receive the WHO PQS prequalification.
Ultra-Low Freezers are used for storing temperature-sensitive specimens, biosamples, vaccines, etc., at temperatures as low as -86°C to enable their long-term and reliable storage. The WHO Performance, Quality, and Safety (PQS) process prequalifies products and devices so that member states and UN purchasing agencies are assured of their suitability for use in immunization programs.
The U201 has a gross storage volume of 214L and provides a storage temperature varying from -86°C to -20°C. Designed with state-of-the-art refrigeration technology, the product offers superior temperature uniformity and holdover time. U201 uses a green refrigerant that has minimal impact on the environment and is compliant with the US SNAP and EU F-Gas regulations.
The unit offers advanced inbuilt alarm systems and provides 24/7 real-time monitoring solutions via the company’s Real-Time Monitoring Devices (RTMD) and °B Connected solution. The password-protected/NFC-based locking mechanism further prevents unauthorized access to the specimens. The product is certified to operate at ambient temperature as high as +43°C and is an ideal solution for last-mile vaccination campaigns, doctor’s clinics, hospitals, etc. The U201 is also a class II(a)/II certified medical device as per EU MDR and US FDA regulation.
Mr. Luc Provost, CEO of B Medical Systems said, “It’s a very proud moment for us. The WHO PQS prequalification is a testament to the quality and standard of our product. The U201 Ultra-Low Freezer offers a compact, reliable, and, sustainable ultra-low freezing solution. The unit can work at ambient temperatures as high as 43°C, making it a perfect solution to be used even in areas with harsh tropical climates.
“We developed this product to meet the growing demand for ultra-low temperature storage of COVID-19 vaccines. However, with the growth of mRNA technology, cell and gene therapy, etc, we see more and more requirements for reliable ultra-low temperature storage across the world.”