Ultra-low temperature (ULT) freezers are used by organizations that require the safe and reliable storage of temperature-sensitive materials at temperatures as low as -80°C, including:

• Hospitals and healthcare facilities
• Clinical and diagnostic laboratories
• Biobanks and biorepositories
• Blood banks and plasma centers
• Pharmaceutical and biotechnology companies
• Research institutes and universities
• Cell and gene therapy laboratories
• Fertility and reproductive medicine clinics
• Contract research organizations (CROs)
• Vaccination centres and storage facilities
• Public health and government research institutions

And any organization requiring a reliable, -80°C long-term storage solution.

Depending on the storage temperature, intended storage duration, and applicable regulations, ultra-low temperature (ULT) freezers can be used to store a wide range of temperature-sensitive materials, including:

• Biological samples such as DNA, RNA, cell cultures, microorganisms, serum, plasma, and research specimens
• Human tissues and cellular therapies, including stem cells, cord blood, bone marrow samples, and hematopoietic progenitor cells
• Blood and blood components, including fresh frozen plasma (FFP), red blood cells, platelets, buffy coats, and reference samples
• Vaccines and biologics, including mRNA vaccines, monoclonal antibodies, clinical trial materials, adjuvants, and vaccine intermediates
• Pharmaceutical products and compounds, including active pharmaceutical ingredients (APIs), drug substances, stability samples, and quality control samples
• Laboratory reagents and diagnostic materials, including enzymes, antibodies, reagents, controls, and reference standards
• Cell and gene therapy materials, including viral vectors, cell therapy products, and advanced therapy medicinal products (ATMPs)
• Forensic and environmental samples requiring long-term preservation for analysis or evidential purposes

*Storage requirements vary depending on the material being stored, the required storage duration, and applicable local regulations and guidelines. B Medical Systems recommends adhering to the relevant scientific, medical, pharmaceutical, and regulatory requirements when determining storage conditions.

Yes. B Medical Systems' Ultra-Low Temperature Freezers are Class IIa medical devices compliant with the European Medical Device Regulation (EU MDR) and US FDA requirements. The U Range also complies with DIN 13277, supporting the regulatory, quality, traceability, and performance requirements of healthcare facilities, laboratories, biobanks, pharmaceutical companies, and research institutions.

To further support compliance in controlled storage environments, B Medical Systems' ULT freezers feature 24/7 real-time monitoring, helping users document storage conditions, maintain temperature records, improve traceability, and facilitate audits and quality management processes.