Noxilizer Room-temperature Sterilization

Independent Sales Representative’s OVERVIEW

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Barry Technical Sales welcomes Noxilizer, an emerging leader in the medical device field. You know BTS for staying on the cutting edge of new techologies; Noxilizer is a great example of the leadership we strive to exemplify.

Noxilizer has is a new sterilization technology based upon Nitrogen DiOxide (NO2). This is next-generation, eco-friendly technology that allows the manufacturer to sterilize in-house and/or provide contract sterilization services. The result? Faster delivery to end-users.

You have the option of in-line or free-standing installation. This room-temperature method of gas sterilization is applicable to even bio-resorbables and pre-filled syringes.  And because it is a surface sterilization process, long muti-lumen tubing can be sterilized easily.

Submitting a 510(k)? Please forward your Non-disclosure agreement (NDA), so that we can discuss the compatibility of your materials and NO2 sterilization.

Noxilizer’s proprietary low temperature sterilization technology is the first innovation in the industry in over 20 years. The advantages over existing modes of sterilization are: room temperature process, fast cycle time and improved worker safety over existing methods. The system allows for inventory release in hours versus weeks and cost savings of 40% to 60% for medical devices companies.

Contract Sterilization Services

Noxilizer offers contract sterilization services for medical devices using its proprietary, room temperature NO2 sterilization process at its Baltimore, MD facility. Noxilizer’s NO2 sterilization service provides cost savings to medical device manufacturers with a fast turnaround of sterile product. Cycle times are much shorter because lengthy preconditioning and post-exposure aeration phases of the cycle are eliminated with the NO2 technology. Packaged sterile product can be handled immediately after the cycle, allowing it to be returned to inventory quickly.

Noxilizer’s NO2 sterilization process can be customized to the specific needs of device manufacturers who have particularly challenging sterilization issues. The humidity of the cycle can be varied to accommodate products that are sensitive to moisture, and pressure sensitive devices can be sterilized using cycles that do not depart significantly from ambient pressure.

Laboratory Services

Noxilizer’s in-house microbiology and materials science team performs testing in support of customer sterilization requirements. In-house microbiological testing is carried out in conformance with the appropriate ISO standards. Noxilizer also retains the services of highly qualified external laboratories to perform additional tests involving product quality and safety. Having Noxilizer coordinate this testing is often more convenient for sterilization customers.

QUALITY AND REGULATORY

Noxilizer performs sterilization of medical devices under ISO 14937:2009 Noxilizer’s sterilization operations comply with the US FDA Quality System Regulation (21CFR820) and conform to ISO 13485:2003 for regulatory purposes. Noxilizer maintains the capability to conduct studies in compliance with the Good Laboratory Practices (21CFR58) upon request.

Benefits over Ethylene Oxide (EO)

ATTRIBUTE

NOXILIZER

EO

Turnaround Time

1 day or less

Days to Weeks

Residues

Non-cytotoxic

Cytotoxic, carcinogenic

Temperature

18°C to 30°C >

40°C

Humidity

0% RH to 90% RH

~65% RH

IN-HOUSE

  • Bioburden Testing
  • Biological Indicators
  • Feasibility Studies
  • Materials Compatibility – FTIR Spectroscopy
  • Extraction of Residuals / Residues
  • Sterilization Validation

All tests are performed within the scope of ISO14937:2009. Noxilizer typically utilizes the overkill method of validation.

PLEASE INQUIRE ABOUT ADDITIONAL TESTING SERVICES

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barrytechsales@gmail.com
847-910-7922 direct/text

412 Bramble Lane, Deer Park, IL 60010 USA

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