• Enhanced ULT Freezers for Cell and Gene Therapies

Refrigerators / freezers

Enhanced ULT Freezers for Cell and Gene Therapies

Sep 21 2023

Thermo Fisher's TSX and TDE Series ultra-low freezers have been independently tested and certified by Underwriters Laboratories (UL) to conform to ISO 14644-14:2016 standards, specifically achieving ISO Class 5.5 cleanroom standard limits, ranging from 0.1 μm to 1.0 μm. This designation is crucial for ensuring product integrity in sensitive cleanroom environments.

Cell and gene therapy products, including live cells, genetic materials, and viral vectors, are highly susceptible to temperature variations and contamination. Maintaining the quality and viability of these materials is paramount for their effectiveness and safety. Thermo Fisher's ultra-low freezers are now better equipped to safeguard these materials, as they can be placed closer to the workflow, ensuring controlled storage environments.  

Achieving ISO 14644-14:2016 Class 5.5 cleanliness classification addresses several critical challenges related to regulatory compliance, product integrity, cross-contamination prevention, data integrity, and adherence to Good Manufacturing Practices (GMP). These freezers significantly contribute to the secure and efficient development and manufacturing of cell and gene therapies.

Thermo Fisher Scientific offers a range of ultra-low temperature freezers, with sizes from 14.9 cu. ft to 33.5 cu. ft and various voltage options. This diversity ensures that biopharmaceutical researchers and scientists have access to models tailored to their specific needs, all adhering to ISO Class 5.5 cleanroom standards.

Thermo Fisher Scientific remains committed to providing innovative solutions that meet the evolving requirements of the scientific and healthcare industries. By attaining ISO Class 5.5 cleanroom designation for the TSX and TDE series Ultra-Low Freezers, Thermo Fisher Scientific expands its portfolio, offering a comprehensive range of cold storage solutions, from +5°C to -86°C.

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