Ultra-low Temperature Sterilization with Nitrogen Dioxide

N02 Sterilization: 10-30°C. Vacuum Optional.™

Noxilizer sells the proprietary Nitrogen Dioxide sterilization process. Noxilizer’s expert microbiology and material compatibility team is ready to partner to solve sterilization challenges through every phase of the process.  

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We provide ultra-low temperature (10°C to 30°C) nitrogen dioxide sterilization technology that offers many benefits over traditional sterilization methods.

Noxilizer is the expert in the application of the N02 process within the supply chain

Noxilizer sells sterilization equipment to pharmaceutical, biotech and medical device manufacturers and also offers contract sterilization services.

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Applications

Prefilled Syringes and
Combination Products

Nitrogen dioxide gas sterilization is ideal for these sensitive biotech products:

  • Ultra-low temperature sterilization (10°C – 30°C) — maintains drug integrity
  • Minimal vacuum option — prevents stopper movement
  • Surface sterilization process — does not leach through the stopper
  • Short cycle times (6-12 hours including aeration time)
  • Safe and easy to bring sterilization in house – improves supply chain efficiency

Sensors

Nitrogen dioxide gas sterilization offers benefits for this new technology:

  • Flexible humidity settings ranging from 40% to 85% — maintains sensor chemistry
  • No cytotoxic residuals – protects sensor performance
  • Safe and easy to bring sterilization in house – improves supply chain efficiency

Orthopedic Implants

Nitrogen dioxide gas sterilization reduces sterilization costs and accelerates turnaround time, especially for custom implants:

  • Short cycle times (3-6 hours) – improves supply chain efficiency and significantly reduces sterilization costs
  • Safe and easy to bring sterilization in house – returns timeline control to the medical device manufacturer

Recent Publications

Regeneron study notes that Nitrogen Dioxide (NO2) sterilization ensures drug integrity and lowers the risks of adverse effects with IVT

Posterior eye problems are often treated with intravitreal (IVT) therapies, however, IVT is linked with specific medication, equipment, and process issues that may lead to adverse effects. This study shows that by lowering the number of steps necessary for dosage preparation, pre-filled syringes can increase product stability and effectiveness and provide a safer alternative than glass containers when it comes to container closure and drug delivery.  (Read More)

Terumo study finds that NO2 sterilized WFI-filled syringes have immeasurable NO2 ingress when compared to EO and VHP

Because of this, polymer-based prefilled syringes (P-PFSs) have revolutionized the pharmaceutical industry, however, to limit the risk of infection, exterior sterilization of P-PFSs is necessary. Though sterilization of P-PFSs has proven difficult with other technologies, Noxilizer’s sterilization technology uses NO₂ gas which effectively sterilizes the external surface of pre-filled syringes with no or minimal ingressing into the drug product – a technology that ensures drug integrity and lowers the risks of adverse effects with IVT.  (Read More)

Case Studies

European Biotech is First Company to Select NO₂ Sterilization for Ophthalmic Drug-Device Combination Product
In 2018, a European biotech company contacted Noxilizer to evaluate nitrogen dioxide (NO₂) sterilization for its first product, an ophthalmic drug-device combination product. The company was interested in NO₂ due to the ultra-low temperature, surface sterilization and relatively short total process time. In addition, NO₂ contract sterilization was planned in Europe, making access to NO₂ geographically available for their current supply chain. Two feasibility studies were completed in 2019 and 2020. The results of these studies confirmed the vacuum budget for this project, guidance on the cycle parameters prior to starting sterilization validation following ISO 14937, and that there was minimal ingress in the pre-filled syringes at 24 hours and 30 days. The company filed for commercial regulatory approval with EMA in 2021 and expects final approval in the summer of 2022.
Global Biotech Company Picks NO₂ Sterilization over EO for Their Ophthalmic Drug Device Combination Product
In 2019, a global biotech company product team was evaluating multiple syringe types and sterilization methods, including ethylene oxide (EO) and nitrogen dioxide (NO₂). Noxilizer staff became “a part” of the product development team, attending weekly meetings, providing guidance on backstop clip design, sterile barrier packaging, etc. During this time, the team conducted a number of feasibility studies to assess: the syringe brands and designs, vacuum budget, lethality cycles to confirm the most challenging location and initial cycle parameters, ingress and external residuals. The biotech company identified the leading syringe design candidate. This design reduced risk to the product during the manufacturing process and Quality Control assessment. During testing conducted by the biotech company, they determined that only NO₂ sterilization worked with this syringe design. EO did not. Therefore, the company selected NO₂ sterilization. Since 2019, the company has executed a number of sterilization studies with their product and packaging. They are in the process of validating the sterilization process in two locations. This product will be submitted for regulatory approval in 2023. The expected commercial product will be available in 2024.
NO₂ Selected as Sterilization Method for Global Biotech Company’s Therapeutic Platform – One Syringe Design and NO₂ Sterilization for all Products in Development
For pharmaceutical and biotech companies with large portfolios of products in one therapeutic area, developing a standard delivery device and sterilization method will accelerate product development and time to market. Noxilizer has worked with a global biotech company for over four years as they evaluate a number of syringe designs and sterilization methods (including, EO, VHP, Peracetic Acid and NO₂). The initial testing showed that only ethylene oxide (EO) and nitrogen dioxide (NO₂) could achieve lethality in the most challenging location in the various syringe designs. Therefore, further testing has been done to assess the pros and cons of EO and NO₂. The extensive testing includes evaluating product and water-filled syringes that have been exposed to worst-case NO₂ cycle conditions – accelerated and real-time testing over 24 months. In both cases, product and water-filled syringes show minimal to no NO₂ (or nitrates) ingress into the syringe contents. Drug integrity is maintained. This along with the other benefits of ultra-low sterilization, minimal vacuum, and short total process time when compared to EO has led the company to select NO₂ sterilization for all products in development within this therapeutic area.
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email us at: info@noxilizer.com