Norman Noble Clean Room Upgrade Meets ISO 14644 Class 7 Standards.Enables Clean Room Packaged Products to be Shipped Direct to Sterilization.
HIGHLAND HEIGHTS, OHIO – May 10, 2021 – Norman Noble, Inc., a medical device contract manufacturer, today announced it has recently completed an upgrade to its Clean Room and attached Gowning Room to meet the ISO 14644 Class 7 requirements. Previously certified to ISO class 8, the new class 7 certification permits only 10% of the airborne particulate allowed under class 8. Testing is completed with a Light Scattering Airborne Particulate Counter (LSACP) sampling one cubic meter of air at a time. Samples are taken in 13 discrete locations within the Clean Room while it is in use.
“This improvement is intended to meet and exceed our customers’ needs for increasingly strict product cleanliness requirements” according to Dave Saletrik, NNI’s Director of Quality Assurance. The Clean Room is used for final assembly and packaging of finished medical devices and medical device components with strict cleanliness requirements. This is especially critical for customers who do no further down-stream cleaning of their products. It also allows NNI to ship finished, packaged medical devices direct to sterilization, saving our customers time and transportation costs. The ISO 14644 Class 7 requirements include strict requirements to control factors such as clothing, gloves and masks, regular cleaning and disinfection procedures, unidirectional airflow and regular testing for particulate and microbial contamination levels. NNI takes extra measures to assure product integrity by alternating through multiple types of disinfectants and maintaining a strict latex-free environment.
Download our Cleanroom Upgrade Meets ISO 14644 Class 7 Standards Press Release.
Download our ISO Class 7 Certification.