Noxilizer Laboratory Services
Experienced and Talented Microbiology and Materials Science Team
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.
|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
|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.