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Noxilizer NO₂ sterilization used by global pharma and biotech companies on products submitted for regulatory approval

Noxilizer NO₂ sterilization

Demand for NO₂ sterilization expands for pharma, biotech, and medical device customers

We’re excited about the growing demand for NO₂ sterilization. Noxilizer will continue to work to increase the global capacity of NO₂ sterilization for customers.”
— Lawrence Bruder, President & CEO of Noxilizer
HANOVER, MD, UNITED STATES, December 1, 2022 /EINPresswire.com/ -- Noxilizer announces that multiple pharmaceutical and biotech companies have completed or are in the process of completing sterilization validation of products that will be submitted to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) starting in early 2023. This marks further advancement in the adoption of nitrogen dioxide (NO₂) sterilization. NO₂ sterilization is rapidly becoming the first choice in sterilization for pre-filled syringes and drug-device combination products.

With the increasing regulatory and environmental challenges for ethylene oxide, NO₂ is considered a leading sterilization alternative for many medical devices.

NO₂-based sterilization was first commercialized by Noxilizer in 2012 and offers several key advantages: ultra-low temperature (10°-30°C), minimal pressure requirements, no/minimal residuals, and fast cycle times (6 - 12 hours, including aeration). NO₂ sterilization opens new avenues for innovation and has been shown to be particularly effective in the sterilization of prefilled syringes, drug-device combination products, and custom implants.

Noxilizer customers have a variety of ways to access NO₂ sterilization. Pharmaceutical and biotech companies have purchased NO₂ sterilizers and installed them in their own manufacturing facilities or in contract manufacturing organizations (CMOs). Currently, there is a contract sterilization location in Europe and at Noxilizer’s facility in Hanover, MD. There are NO₂ production sterilizers installed in Europe, the US, and in Q1 2023, Asia. Noxilizer will be expanding its capacity early next year and is in active discussions with other companies interested in adding NO₂ sterilization.

“We’re excited about the growing demand for NO₂ sterilization,” states Lawrence Bruder, President & CEO of Noxilizer. "Noxilizer will continue to work to increase the global capacity of NO₂ sterilization for customers.”

For more information about NO₂ sterilization, contact Maura Kahn at mokahn@noxilizer.com.

About Noxilizer, Inc.:

Noxilizer is a fast-growing medical technology company that provides ultra-low temperature nitrogen dioxide sterilization that offers many benefits over traditional sterilization methods. Our customers are the leading global pharmaceutical, biotech, and medical device companies developing the next generation of products. Noxilizer products and services include feasibility studies, validation, contract sterilization, consulting, sterilization equipment, consumable product line, and customer and technical service. Noxilizer’s headquarters are in Hanover, MD, and the company has an office in Japan. For more information, please visit: www.noxilizer.com.

Maura O. Kahn
Noxilizer, Inc.
mokahn@noxilizer.com
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