Noxilizer and Getinge La Calhène Present the Moduline(TM) BioDecontamination, a Fast cost-effective New Solution for Biodecontaminating Syringe Tubs Using Nitrogen Dioxide, at INTERPHEX New York, 26-28 April 2016
Fast tub processing module goes on show on Getinge’s booth #3133
Baltimore, MD and Vendôme, France - Noxilizer, Inc., the company advancing a room temperature, NO2-based sterilization process for bio-pharmaceutical manufacturers, and Getinge-La Calhène, a leader in the isolation technologies segment, launch a breakthrough in Ready-To-Use technology: the Moduline™ Bio-Decontamination. With its unique BIOTRACE (Noxilizer Inside™) technology, process throughput is 20 tubs every 20 minutes with 100% validated 6-log reduction.
The prefilled syringe market continues to grow. To meet demand, companies are installing small, medium and high speed filling lines, depending on production needs. Industry experts say that the majority of filling lines installed each year are small to medium speed lines, filling 100 to 200 syringes per minute, or about 1 to 2 syringe tubs per minute. Various methods are used to negate the risk of microbial contamination of the outer surface of the tubs on insertion into aseptic filling lines. Noxilizer and Getinge La Calhène have developed a new rapid sterilization process integrated into a compact module which is positioned upstream of an aseptic filling line.
Fast biodecontamination cycles are enabled by the use of BIOTRACE (Noxilizer Inside™) technology. The nitrogen dioxide generator and scrubber are integrated inside the module and are controlled by the same HMI. Sterilant gas is delivered in situ, on demand, so no sterilant containers are required. The gas is non-flammable, non-explosive and non-carcinogenic.
The key advantages of NO2:
Total Process Time (TPT) is half the time of HPV – improving efficiency with less cost
NO2 decontaminates under the syringe tub lip – maintaining the sterility of the isolator
Aeration to ppb (environmental) residual sterilant level in minutes – reduces risk for biologic products
The Moduline™ Bio-Decontamination is part of the Moduline™ modular range of aseptic filling
lines inside isolators, the filling equipment being supplied by DARA-Pharma (Granollers, Spain).
It is installed upstream of the semi-automated Moduline™ Delidding and Denesting Module, and the Moduline™ Syringe Filling Module. At INTERPHEX New York, 26-28 April 2016, the Moduline™ Bio-Decontamination unit will be displayed on Getinge’s booth #3133. The Moduline™ Aseptic Filling Line (Vials) will be displayed on NJM Packaging booth #2353.
About Getinge La Calhène:
Getinge La Calhene supplies isolation technology and the DPTE® safe transfer system to the Biopharma industry. From compact equipment to modular isolators for filling lines, Getinge La Calhene provides cGMP solutions for a variety of aseptic applications. The company supplies the DPTE® range of transfer ports and Beta accessories for ultra-clean and sterile transfer. Getinge La Calhene is part of the Getinge Group, a global leading medical technology company.
See more at www.getinge.com. Â
About Noxilizer, Inc.:
Noxilizer, Inc. provides an ultra-low temperature nitrogen dioxide sterilization technology that offers many benefits over traditional sterilization methods. Noxilizer sells sterilization and biodecontamination equipment to pharmaceutical, biotech and medical device manufacturers and also offers contract sterilization services at its Baltimore, MD facilities. Noxilizer's expert microbiology and material compatibility team is ready to partner to solve sterilization challenges through every phase of the process. Noxilizer, Inc. has offices in the US, United Kingdom and Japan. For more information, please visit: www.noxilizer.com.
Media Contacts:
GLC Press Contact at INTERPHEX
Paulo A. Liverani
Filling Lines Sales Manager
Getinge La Calhènee
O (+33)2 5473 4747
C (+33)6 3207 3725
Marketing-contact.glc@getinge.com
NOXILIZER Press Contact at INTERPHEX
Maura O. Kahn
Vice President, Business Development Marketing
Noxilizer, Inc. O (443) 842-4403
C (202) 744-6337
mokahn@noxilizer.com
