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B Medical Systems has received the worlds-first PQS prequalification from the World Health Organization (WHO) for its U201 Ultra-Low Freezer

Ultra-Low Freezers are used for storing temperature-sensitive specimens, biosamples and vaccines at temperatures as low as -86°C to enable their long-term and reliable storage. The WHO Performance, Quality, and Safety (PQS) process prequalify products and devices so that member states and UN purchasing agencies are assured of their suitability for use in immunization programs.

B Medical Systems developed the U201 Ultra-Low Freezer in response to the growing demand for ultra-low temperature storage of COVID-19 vaccines.

Commenting on the world-first, Luc Provost, CEO of B Medical Systems, said: “WHO PQS prequalification is a testament to the quality and standard of our product.  The U201 Ultra-Low Freezer can work at ambient temperatures as high as 43°C, which means it’s ideal for use in tropical climates. We developed this product as a pandemic response however, with the growth of mRNA technology, such as cell and gene therapy, we see more and more requirements for reliable ultra-low temperature storage across the world.”

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, it offers superior temperature uniformity and holdover time. It uses a green refrigerant that has minimal impact on the environment and is compliant with the US SNAP and EU F-Gas regulations and 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 and laboratories.  The U201 is also a class II(a)/II certified medical device as per EU MDR and US FDA regulation.