Bio-One Sciences Has UVC Disinfection for MedTech Cleanrooms
bio-science (Suffield, Connecticut) recently launched its non-invasive, chemical-free UVC disinfection for medical device manufacturing cleanroom.
The company’s process uses robotic technology — the Thor UVC Disinfection System From Finson Tech. It emits a disinfectant and sporicidal dose of UVC to kill viruses, bacteria and molds. Creatures can contaminate cleanroom facilities.
Peter Combs, founder and president of Bio-One Sciences, said, “Cleaning of medical device sanitisers with excessive caustic compounds can be hazardous to employees, damage electronic equipment and can be corrosive to stainless steel.” Is.”
“Our new service provides a fast and effective continuous wave of UVC energy that neutralizes the DNA of germs and pathogens. This eco-friendly process eliminates the guesswork and ineffectiveness associated with manual cleaning and disinfection,” Combs said in a September 26 news release.
Bio-One Sciences says its service achieves 360-degree disinfection coverage of cleanroom space, furniture and equipment surfaces. It requires only a few hours to execute, requires no cleanup, and complies with 21 CFR Part 820 Guidelines for cGMP manufacturing. In addition, the service generates a project report with exposure time and date, equipment used, calibration data, dosimeter readings and disinfection maps – information needed to demonstrate FDA compliance.
“This new service offers clean floor-to-ceiling disinfection, minimizes facility shutdowns, and provides significant cost and time savings compared to alternative methods,” Combs said.
The company will initially offer its disinfection services in the New York and New England areas.
Bio-One Sciences says validation test supports its technology
Richko Laboratories conducted a validation test of Bio-One Sciences UVC disinfection in the cleanroom at Holyoke Community College in Holyoke, Massachusetts, according to Bio-One.
After UVC exposure, biological indicators (B. pumilus spores) showed a 2.93 logarithm reduction – the equivalent of killing 97.7% of organisms. Other species, such as E. coli and MRSA, are not resistant to UVC radiation and will be killed under the conditions of these validation activities, according to Bio-One Sciences.
“This data supports the fact that the Bio-One Sciences UVC process can disinfect a cleanroom under the high-level disinfection level of the Spalding classification scheme – meaning it kills spores, botanical bacteria and fungi,” said Dr. Steven Richter, President and Senior Scientist at Richco Laboratories.
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