Thermo Fisher freezers now ISO Class 5.5 designated for CGT applications

Thermo Fisher Scientific TSX and TDE Series ultra-low freezers are tested according to ISO 14644-14 and designated ISO Class 5.5; operational; 0.1 μm, 0.2 μm, 0.3 μm, 0.5 μm, 1.0 μm, contributing to the safe and effective development and manufacturing of cell and gene therapies.

Thermo Scientific TSX and TDE Series ultra-low freezers have been independently tested and designated by Underwriters Laboratories (UL), in accordance with ISO 14644-14:2016, to meet the International Organization for Standardization (ISO) Class 5.5; operational; 0.1 μm, 0.2 μm, 0.3 μm, 0.5 μm, 1.0 μm cleanroom standard limits. This designation helps deliver innovative solutions that meet the evolving needs of the scientific and healthcare industries for sensitive cleanroom settings.

Cell and gene therapy products, including live cells, genetic materials, and viral vectors, are often highly sensitive to temperature fluctuations and contamination. Maintaining the integrity of these materials is crucial for their efficacy and safety. This designation ensures that TSX and TDE series ultra-low temperature freezers can be used in closer proximity to the workflow, preserving the quality and viability of cell and gene therapy products in controlled environments. In addition, the manufacturing of life-saving drugs, sterile preparations and biological products benefit from the safety and consistency of this series of ULT freezers.

Having an ultra-low temperature freezer tested and designated to ISO 14644-14:2016 Class 5.5: operational; 0.1 μm, 0.2 μm, 0.3 μm, 0.5 μm, 1.0 μm provides cell and gene therapy companies with confidence in the cleanliness and control of their storage environments. It addresses key challenges related to regulatory compliance, product integrity, cross-contamination prevention, data integrity, and Good Manufacturing Practice (GMP) adherence, contributing to the safe and effective development and manufacturing of cell and gene therapies.

With five option sizes available (from 14.9cu. ft to 33.5cu ft) and three voltage options, Thermo Fisher Scientific ensures that researchers and scientists in the biopharmaceutical industry have access to a matrix of comparable models, all tested according to ISO 14644-14 and designated ISO Class 5.5; operational; 0.1 μm, 0.2 μm, 0.3 μm, 0.5 μm, 1.0 μm cleanroom standard.

Thermo Fisher Scientific is committed to delivering innovative, healthier, cleaner and safer solutions that meet the evolving needs of the scientific and healthcare industries. By obtaining ISO Class 5.5 cleanroom designation for the TSX and TDE series Ultra-Low Freezers, Thermo Fisher Scientific now provides a full spectrum of cold storage solutions, from +5C to -86C.

Key applications:
Manufacturing drugs, sterile preparations, and biological products. Cell and gene therapy.

Features/benefits:

• Thermo Scientific™ Ultra Low Freezers tested according to ISO 14644-14 and designated ISO Class 5.5; operational; 0.1 μm, 0.2 μm, 0.3 μm, 0.5 μm, 1.0 μm
• Large offering of solutions at ultra-low temperatures
• Entire Cold Storage Spectrum offering (+5 to -86)
• Five option sizes available (from 14.9cu. ft to 33.5cu ft) and three voltage options
• The level of classification is lower (ISO 5.5 vs competitor claims to ISO 6), and the product offering is wider (both by size configuration and temperature range) which allows flexibility in workflow
• Enhanced Good Manufacturing Practice (GMP) Compliance

MB Bureau