Telstar has introduced the new ionHP biodecontamination system for use in pharmaceutical aseptic enclosures, an innovative technology which resolves some of the traditional difficulties associated with H2O2 biodecontamination processes. Unlike conventional systems, the ionHP technology developed by Telstar for application in aseptic isolators increases the efficacy of the decontamination process and reduces degradation of construction materials by virtue of requiring a very low concentration of H2O2. Reduced bio-decontamination cycle times are possible since the process efficiency is not affected by temperature and humidity and therefore there is no need to pre-condition the chamber prior to H2O2 injection.
An essential process biodecontamination technology has been developed in response to the increasing demand of the manufacture of sterile potent drugs, which brings increased need for sterility testing. A biodecontamination system is an essential feature of all sterility test isolators, providing a reliable and repeatable method of sterility assurance.
Conventional decontamination systems use vaporized H2O2 to decontaminate the internal surfaces of the isolator and external surfaces of internal process equipment and product packages before testing begins.
More than three years ago, following intensive research by the Technology Centre for Barrier Isolation Systems of Telstar, located in the United Kingdom, the company identified an alternative decontamination system, using ionHP (ionized Hydrogen Peroxide) specifically aimed to aseptic pharmaceutical processes. The initial applications for ionHP had been for large warehouses, hospitals and airplanes and intended for single use, therefore the control systems requirements were basic.
Telstar has pioneered the development of this system for aseptic isolation technology thereby introducing a viable alternative to traditional systems. The ionHP system has been designed into the Telstar standard sterility test isolator range mechanically, electronically and through software; the result being a PLC based integrated system. This has been followed by extensive testing to provide a proven, globally validated system that provides repeatability. This has resulted in significant technological advancement through the innovative use of a unique decontamination system, previously applied in a different industrial sector.
