Noxilizer will supply Nox Flex systems with Getinge isolators
Noxilizer has signed an exclusive agreement with Getinge-La Calhene to provide the Nox Flex rapid bio-decontamination units for Getinge isolators
Noxilizer, a North American company advancing a room temperature, NO2-based sterilisation process for biopharmaceutical manufacturers, has signed an exclusive agreement with Getinge-La Calhène, a leader in isolation technologies.
Under the agreement, Noxilizer will provide Nox Flex rapid bio-decontamination units for Getinge-La Calhène’s isolator systems.
Today, isolators are used throughout the bio-pharmaceutical industry. After an isolator is opened, it must be bio-decontaminated before it may be used again. The current bio-decontamination technology is hydrogen peroxide vapour (HPV), introduced more than 20 years ago. The Nox Flex uses nitrogen dioxide (NO2) and provides a bio-decontamination process that takes half the time of HPV, leading to improved efficiency and productivity of the manufacturing process.
As a benchmark comparison: for isolator decontamination with identical lethality and process conditions, NO2 has a process time ~50% of HPV. For example, in a 1m3 isolator with aeration to 1ppm, total process time is 45min. Aeration to 0.1ppm (=100ppb) takes approximately 60 minutes. Typical process time for lock-chamber decontamination is <15min.
This is validation of the important benefits of nitrogen dioxide in sterilisation and bio-decontamination for the pharmaceutical and biotech industry
Another benefit of NO2 is that residual levels may be reduced to part-per-billion levels, a valuable feature for sensitive drug products, and according to Baltimore-based Noxilizer, a feature that is very difficult to achieve with HPV.
Noxilizer says other advantages of NO2 technology are that it is a room/ambient temperature process and is effective against a wide range of organisms. It is safe and simple to use and a faster process than other methods. It is also effective at low humidity levels and allows de-contamination in moisture-sensitive environments. It is also compatible with a wide range of materials including sensitive electronic devices.
Lawrence Bruder, CEO of Noxilizer, said: 'Getinge-La Calhène is the leader in the isolation technology segment and we are excited to be working with them. This is validation of the important benefits of nitrogen dioxide in sterilisation and bio-decontamination for the pharmaceutical and biotech industry.'
'The Nox Flex rapid bio-decontamination system demonstrates Getinge-La Calhène’s ability to bring new solutions that lead to improved efficiency and outcomes,' added Thierry Girard, President of Getinge-La Calhène. 'Focusing on the success of our customers leads to success for Getinge-La Calhène.'
The two companies will be launching their joint effort at next month's ACHEMA in Frankfurt, Germany.