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Thermo Fischer Scientific Reports the Launch of the First-Ever GMP- and Cleanroom-Compatible CO2 Incubator

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Thermo Fischer Scientific has launched a first-in-market CO2 incubator that combines optimal cell growth capabilities with certified cleanroom compatibility, effectively addressing the growing need among biotechnology, biopharmaceutical, and clinical laboratories for high-performance incubation systems that meet stringent cleanroom and cGMP standards.

Thermo Fischer Scientific Heracell Vios CR CO2 Incubator expands the Thermo Scientific Cell Therapy Systems (CTS) Series laboratory equipment portfolio with a solution specifically designed for use in GMP environments. Consistent with Thermo Fisher’s history of proven incubator technology, the new system provides optimal cell growth for even the most sensitive high-value cell cultures.

This new Vios CR CO2 incubator boasts fully enclosed casing and electronics, minimizing particle emissions in sync with critical particulate control in a Grade A/B cleanroom. Operating on the patented Thermo Scientific THRIVE active airflow technology, which delivers homogenous cell growth conditions and rapid parameter recovery in less than 10 minutes, the system prioritizes cell culture protection. Dependable contamination control is enabled through in-chamber HEPA filtration, on-demand 180°C sterilization, and an optional 100% pure copper interior chamber.

Featuring a robust stainless-steel exterior and IP54-compliant design, the Vios CR CO2 incubator can withstand the rigorous and repeated cleaning procedures that are integral to effective cleanroom management, enabling long-term use and maximum return on investment. The system is compatible with the STERIS Vaporized Hydrogen Peroxide (VHP) decontamination method, facilitating easy integration into existing sterilization workflows. Furthermore, the new incubator features independent TÜV SÜD certification for compatibility with ISO Class 5 cleanrooms, allowing scientists to confidently and effectively plan their cleanrooms to meet strict air quality requirements.

“As innovative research is being rapidly translated into promising therapies, we have seen dramatic growth in demand for premium incubators that are suitably equipped for use in controlled environments,” said Douglas Wernerspach, senior business director, Laboratory Products Division at Thermo Fisher Scientific. “To effectively meet this need, we have complemented the demonstrated recovery and uniformity capabilities of the Thermo Scientific Heracell VIOS CO2 Incubator and Thermo Scientific Forma Steri-Cycle CO2 incubators with exceptional cleanability and GMP-enabling features to deliver the first CO2 incubator that is specifically built for cleanroom use. This marks the latest step in our journey to better support cell therapy developers as they seek to bring innovative new therapeutics to patients.”

The new incubator comes with a range of cleanroom-compatible accessory options, including stacking adapters and roller bases to facilitate easy insertion into established laboratory processes. In addition, a comprehensive cGMP documentation package with recommended cleaning procedures and preventative maintenance protocols supports user-friendly, time-efficient implementation and validation.

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Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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