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Noxilizer, Inc., the organization rapidly advancing the room-temperature, nitrogen dioxide (NO2) based sterilization process for life science manufacturers, announces expansion of their contract sterilization operations. This expansion was triggered by growing customer demand and increased industry acceptance of Noxilizer’s NO2 sterilization -- a powerful, efficient and cost-saving alternative to traditional sterilization methods.
"Manufacturers have quickly recognized the advantages of NO2. This expansion was mandated by a significant increase in customer feasibility studies alongside contract sterilization work," notes Maura O. Kahn, vice president of business development and marketing. "Our facility now provides customers even greater access to our NO2 technology with efficient and economical off-site processing."
NO2 sterilization continues to gain recognition as an ideal sterilization alternative for pressure and temperature-sensitive products. NO2 is safe and simple to use. It sterilizes with or without a vacuum and is effective at low humidity levels. In addition to the technological advantages of NO2, Noxilizer contract sterilization services may provide cost savings to manufacturers with a fast turnaround of product. Cycle times are notably shorter, as lengthy preconditioning and post-exposure aeration phases of the cycle are eliminated with NO2. And, packaged sterile product can be handled immediately after the cycle, allowing it to be returned to inventory quickly.
Noxilizer’s state-of-the-art, 16,000 square foot facility, located within the University of Maryland BioPark includes office, laboratory, manufacturing and contract sterilization space. Noxilizer offers a full range of services: testing, validation, cycle development and sterilization of medical devices. An expert in-house team of materials scientists and microbiologists are dedicated to working with customers from feasibility studies through process validation. Adds Evan Goulet, PhD, Noxilizer's director of sterilization operations, “We are committed to solving our customer’s sterilization challenges with technical expertise and custom solutions that meet their unique needs.”
Noxilizer performs sterilization of medical devices under ISO 14937:2009. Sterilization operations comply with the FDA Quality System Regulation (21CFR820) and conform to ISO 13485:2003 for regulatory purposes.
Source: Noxilizer, Inc.