Call 443 842-4421 or email info@noxilizer.com

Noxilizer Laboratory Services

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.

In-House Testing

Test Description
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.

External Laboratory Testing

Test Description
LAL Testing Blood-contacting devices must be verified to be non-pyrogenic.  This test quantifies bacterial endotoxin contamination of sterile devices to be labeled as non-pyrogenic.
Biocompatibility Tests to determine the effects of exposed product on biological systems as required during cycle development and validation.
Materials Compatibility – Mechanical Properties Noxilizer works with materials testing laboratories to determine materials compatibility with the NO2 sterilization process.
Residual Testing Residuals extracted from exposed product are characterized and quantified (may be performed in-house as well).

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

BSI

ISO 13485:2003
FM 562812

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 Mike Valentine at mvalentine@noxilizer.com.