Bio-One Sciences (Suffield, Connecticut) recently launched its non-invasive, chemical-free UVC disinfection for medical device manufacturing cleanrooms.
The company’s process uses robotic technology — the Thor UVC disinfection system from Finsen Tech. It emits a germicidal and sporicidal dose of UVC to kill the viruses, bacteria and molds. The organisms can contaminate cleanroom facilities.
“Washing down medical device cleanrooms with highly caustic compounds can be dangerous to employees, damaging to electronic equipment, and corrosive to stainless steel,” said Peter Coombs, founder and president of Bio-One Sciences.
“Our new service delivers a fast and effective continuous wave of UVC energy that deactivates the DNA of germs and pathogens. This environmentally friendly process eliminates the guesswork and ineffectiveness associated with manual cleaning and disinfection,” Coombs said in a Sept. 26 news release.
Bio-One Sciences says its service achieves 360-degree disinfection coverage of the cleanroom space, furniture, and equipment surfaces. It requires only a few hours to perform, 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 map — information needed to demonstrate FDA compliance.
“This new service offers cleanrooms faster floor-to-ceiling disinfection, minimizes facility closure, and provides significant cost and time savings compared to alternative methods,” Coombs said.
The company will initially offer its disinfection services in the New York and New England areas.
Bio-One Sciences says validation testing backs its tech
RichCo Laboratories conducted validation testing of Bio-One Sciences UVC disinfection in the cleanroom at Holyoke Community College in Holyoke, Massachusetts, according to Bio-One.
After the UVC exposure, the biological indicators (B. pumilus spores) showed a 2.93 logarithm reduction — the equivalent of destroying 97.7% of the organisms. Other species, such as E. coli and MRSA, are not resistant to UVC radiation and would 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 Spaulding Classification Scheme — meaning it kills spores, vegetative bacteria, and fungi,” said Dr. Steven Richter, president and senior scientist at RichCo Laboratories.