News & Events

≪ Back to All News & Events

February 27, 2015

Noxilizer RTS Series NO2 Sterilizers Approved for CE Mark under the Medical Device Directive

Noxilizer RTS Series NO2 Sterilizers Approved for CE Mark under the Medical Device Directive

Industry Veteran Stephen Morley Advances European Commercial Operations

Noxilizer, Inc., provider of room temperature, nitrogen dioxide (NO2) based sterilization solutions, is pleased to announce that it has been approved for the CE marking of its RTS Series Sterilizers under the Medical Device Directive (MDD). The CE Mark opens the door for sales of Noxilizer RTS products in the European Economic Area (EEA) as well as some non-EEA countries.

The RTS Series offers a range of sterilizers with working capacities ranging from 360 to 5,000 liters. The sterilizers leverage room temperature NO2 technology, a rapid process which offers manufacturers significant technical and economic benefits over traditional sterilization methods. NO2 is an ideal sterilization solution for heat, radiation, pressure and moisture-sensitive devices like prefilled syringes and other medical devices. And, RTS Sterilizer equipment can be safely and easily installed in-house, offering improved manufacturing efficiencies and cost savings.

Noxilizer’s commitment to the European Economic Area was demonstrated last year with the appointment of Stephen Morley as Vice President, European Sales and Service, Noxilizer Limited, the newly established entity for its European operations. Sterilization industry veteran Morley joined Noxilizer with 30 years of successful operational and strategic business development experience, most recently from Getinge Infection Control AB.

“Receiving the CE Mark represents a significant milestone in our European expansion strategy. Under Steve’s leadership, we expect rapid adoption in the EU,” notes Lawrence Bruder, Noxilizer CEO. Adds Morley, “Manufacturers are already enthusiastic about the advantages of NO2. As we continue to showcase our NO2 technology and the RTS Series at a number of European tradeshows and in publications, the response has been tremendous. We look forward to building great partnerships with manufacturers in the region.”

Mary Dadone, Vice President, Regulatory Affairs and Quality Assurance at Noxilizer, emphasizes Noxilizer’s commitment to quality. “The CE Mark and Noxilizer’s two ISO 13485 Quality System Certificates of Registration, one for NO2 based sterilizers and another for contract sterilization, demonstrate Noxilizer’s commitment to its own and its customers quality and regulatory goals. We believe this commitment to safety and quality, combined with Noxilizer’s ability to deliver an effective and economical sterilization alternative, will accelerate the acceptance of NO2 sterilization in the EU.”

For more information about Noxilizer’s RTS Series NO2 Sterilizers, please contact Stephen Morley at his United Kingdom-based, Noxilizer, Limited office at +44 1246 570 777 or at smorley@noxilizer.com.

About Noxilizer, Inc.:

Noxilizer, Inc. provides room-temperature nitrogen dioxide sterilization technology that offers many benefits over traditional sterilization methods. Noxilizer sells sterilization and biodecontamination equipment to pharmaceutical, biotech and medical device manufacturers and also offers contract sterilization services at its Baltimore, MD facilities. Noxilizer’s expert microbiology and material compatibility team is ready to partner to solve sterilization challenges through every phase of the process.
Noxilizer, Inc., founded in 2004, is privately held with offices in the US, United Kingdom and Japan. For more information, please visit: www.noxilizer.com.

Media Contact:

Angie Kearns
Brand Manager
Noxilizer, Inc.
C (574) 304-1502
akearns@noxilizer.com

> Click here to Download PDF