Noxilizer expands contract sterilisation operations
To meet rising demand for nitrogen dioxide sterilisation
Noxilizer, a US specialist in room-temperature, nitrogen dioxide (NO2) based sterilisation for life science manufacturers, has expanded its contract sterilisation operations following growing customer demand and increased industry acceptance of the company’s NO2 sterilisation method.
‘Manufacturers have quickly recognised the advantages of NO2. This expansion was mandated by a significant increase in customer feasibility studies alongside contract sterilisation work,’ said Maura Kahn, Vice President, Business Development & Marketing at the Baltimore-based company.
NO2 sterilisation is gaining recognition as an alternative for pressure and temperature-sensitive products.
This expansion was mandated by a significant increase in customer feasibility studies alongside contract sterilisation work
The company says NO2 is safe and simple to use. It sterilises with or without a vacuum and is effective at low humidity levels.
In addition, the company says its contract sterilisation services may provide cost savings to manufacturers with a fast turnaround of product. Cycle times are notably shorter, as lengthy preconditioning and post-exposure aeration phases of the cycle are eliminated with NO2.
In addition, packaged sterile product can be handled immediately after the cycle, allowing it to be returned to inventory quickly.
Noxilizer’s 16,000ft2 facility, located within the University of Maryland BioPark, includes office, laboratory, manufacturing and contract sterilisation space.
The company offers a full range of services: testing, validation, cycle development and sterilisation of medical devices.
Noxilizer performs sterilisation of medical devices under ISO 14937:2009. Its sterilisation operations comply with the US FDA Quality System Regulation (21CFR820) and conform to ISO 13485:2003 for regulatory purposes.