Bio-One Sciences promotes its UVC disinfection for medical device cleanrooms - Medical Design & Outsourcing

Bio-One Sciences (Suffield, Connecticut) precocious launched its non-invasive, chemical-free UVC disinfection for aesculapian instrumentality manufacturing cleanrooms.

The company’s process uses robotic exertion — the Thor UVC disinfection system from Finsen Tech. It emits a germicidal and sporicidal dose of UVC to termination the viruses, bacteria and molds. The organisms tin contaminate cleanroom facilities.

“Washing down aesculapian instrumentality cleanrooms with highly caustic compounds tin beryllium unsafe to employees, damaging to physics equipment, and corrosive to stainless steel,” said Peter Coombs, laminitis and president of Bio-One Sciences.

“Our caller work delivers a accelerated and effectual continuous question of UVC vigor that deactivates the DNA of germs and pathogens. This environmentally affable process eliminates the guesswork and ineffectiveness associated with manual cleaning and disinfection,” Coombs said successful a Sept. 26 quality release.

Bio-One Sciences says its work achieves 360-degree disinfection sum of the cleanroom space, furniture, and instrumentality surfaces. It requires lone a fewer hours to perform, requires nary cleanup, and complies with 21 CFR Part 820 guidelines for cGMP manufacturing. In addition, the work generates a task study with vulnerability clip and date, instrumentality used, calibration data, dosimeter readings and disinfection representation — accusation needed to show FDA compliance.

“This caller work offers cleanrooms faster floor-to-ceiling disinfection, minimizes installation closure, and provides important outgo and clip savings compared to alternate methods,” Coombs said.

The institution volition initially connection its disinfection services successful the New York and New England areas.

Bio-One Sciences says validation investigating backs its tech

RichCo Laboratories conducted validation investigating of Bio-One Sciences UVC disinfection successful the cleanroom astatine Holyoke Community College successful Holyoke, Massachusetts, according to Bio-One.

After the UVC exposure, the biologic indicators (B. pumilus spores) showed a 2.93 logarithm simplification — the equivalent of destroying 97.7% of the organisms. Other species, specified arsenic E. coli and MRSA, are not resistant to UVC radiation and would beryllium killed nether the conditions of these validation activities, according to Bio-One Sciences.

“This information supports the information that the Bio-One Sciences UVC process tin disinfect a cleanroom nether the High-Level Disinfection level of the Spaulding Classification Scheme — meaning it kills spores, vegetative bacteria, and fungi,” said Dr. Steven Richter, president and elder idiosyncratic astatine RichCo Laboratories.