Noxilizer 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.
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 |
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.
Flexible Cycles
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.
Pathway to Sterilization
As a customer-focused company, the Noxilizer team is flexible and can respond quickly. Below are potential steps in the development of a working relationship.
Noxilizer also has an experienced and talented Microbiology Department to support its sterilization services and customer testing.