Biodecontamination technology for aseptic systems

Telstar has introduced the ionHP (ionised hydrogen peroxide) biodecontamination system for use in pharmaceutical aseptic enclosures, a technology that aims to resolve some of the traditional difficulties associated with H₂O₂ biodecontamination processes.

Unlike conventional systems, the ionHP technology, developed 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, says the company. Reduced bio-decontamination cycle times should be 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.

This biodecontamination technology has been developed in response to increasing demand for 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 vaporised H₂O₂ to decontaminate the internal surfaces of the isolator and external surfaces of internal process equipment and product packages before testing begins.

Initial applications for ionHP had been in large warehouses, hospitals and airplanes and intended for single use, therefore the control systems requirements were basic. Over three years ago, following intensive research by Telstar’s Technology Centre for Barrier Isolation Systems in the UK, the company identified an alternative decontamination system aimed at aseptic pharmaceutical processes that used ionHP. Telstar developed this system for aseptic isolation technology, 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.

ionHP can be used in open air and, once ionised, acts like a gas as opposed to a vapour, which offers operational, commercial and environmental benefits. According to Telstar, ionHP requires a significantly shorter decontamination process time than the traditional alternatives, and it has no requirement for special atmospheric conditions, eliminating the need for air conditioning units required with traditional systems. At the same time, ionHP uses a base concentration of 7.5% volume, whereas traditional H₂O₂ systems use 30–35%. This lower level of concentration is more conducive to shipping worldwide with it being below the threshold level for transportation (especially air transport).

Hydrogen peroxide is the primary component used, which breaks down into oxygen and water at the completion of the decontamination process, making it one of the most environmentally friendly decontaminants available.       

Telstar, www.telstar.com.