Experienced and Talented Microbiology and Materials Science Team
Noxilizer’s expert in-house microbiology and materials science team will work with you to perform sterilization testing to your requirements. We offer a wide range of testing services that conform with ISO standards both in-house at our Baltimore, MD facility and through external labs. Each customer has a dedicated team working through every step of the process.
|Incompatible Materials||Design Alternatives|
|Delrin® (polyacetal)||Polyetherimide, polysulfone, PEEK|
|Nylon®||Polyester or polyolefins|
|Polyurethane||Thermoplastic elastomers (TPE)|
|Cellulosics (some paper)||Polystyrene or polyester label stock|
|Nitinol||Depends upon application|
External Laboratory Testing
|Bioburden Testing||Native bioburden on as-received, non-sterile product is characterized and enumerated.|
|Biological Indicators||Inoculation of actual product can be performed or a process challenge device may be used. Direct enumeration or fraction negative results are reported and interpreted.|
|Feasibility Studies||Engineering cycles performed with no guarantee of sterility. Biological indicators are included and samples are returned for customer evaluation.|
|Materials Compatibility – FTIR Spectroscopy||FTIR spectroscopy is used to characterize any residues and interactions between the sterilant and polymeric materials.|
|Extraction of Residuals / Residues||Extraction is carried out to quantify the amount of residuals and residues on product.|
|Sterilization Validation||All tests are performed within the scope of ISO14937:2009. Noxilizer typically utilizes the overkill method of validation.|
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.
Customer and Technical Service
After the installation in your facility, Noxilizer is still with you every step of the way. We have an experienced and dedicated service team to support the warranty, provide planned maintenance and service.
To learn more about Noxilizer’s nitrogen dioxide sterilization solution and expert team, contact email@example.com.