Reduced bio-decontamination cycle times are possible
The ionHP biodecontamination system for use in pharmaceutical aseptic enclosures
Telstar's new ionHP biodecontamination system for use in pharmaceutical aseptic enclosures, is said to resolve some of the traditional difficulties associated with H2O2 biodecontamination processes.
Unlike conventional systems, the ionHP technology increases the effectiveness of the decontamination process and reduces degradation of construction materials by virtue of requiring a very low concentration of H2O2, the Spanish company says.
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.
Telstar has developed this technology in response to increasing demand for the manufacture of sterile potent drugs, which brings increased need for sterility testing.
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.
The new system is more effective due to the positively charged droplets being attracted to the negatively charged surface areas
More than three years ago, following intensive research by Telstar's UK-based Technology Centre for Barrier Isolation Systems, the company identified an alternative decontamination system, using ionHP (ionised Hydrogen Peroxide) for aseptic pharmaceutical processes. The initial applications had been for large warehouses, hospitals and aircraft and was intended for single use, therefore the control systems requirements were basic, the company says.
Telstar has pioneered the development of this system for aseptic isolation technology thereby introducing an alternative to traditional systems.
The ionHP system has been designed into the company's 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.
Telstar says it has made use of a decontamination system that was previously applied in a different industrial sector, which has resulted in significant technological advancement.
IonHP technology includes a process of ionisation that imparts two characteristics introduced by passing a mist through an ionised plasma field: the electrostatic charge imparted on the mist gives it a behaviour akin to a gas, due to mutually repulsive positively charged particles; and positively charged particles are attracted to negatively charged surfaces in a room or enclosure.
IonHP can be used in the open air and, once ionised, acts like a gas as opposed to a vapour, which offers many operational, commercial and environmental benefits, the company says. In this sense, ionHP requires a significantly shorter decontamination process time than the traditional alternatives and it has no requirement for special atmospheric conditions, which eliminates the need for the air conditioning units required with traditional systems, thereby reducing equipment cost.
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 because it is below the threshold level for transportation (especially air transport).
Telstar says the new system is also more effective due to the positively charged droplets being attracted to the negatively charged surface areas ionHP does not leave behind any residue, reducing costs by shortening cleaning activities.
Hydrogen peroxide is the primary component used, which breaks down into oxygen and water at the completion of the decontamination process, making it environmentally friendly.
Telstar will be presenting the system in Hall 08a Booth E33 at Interpack 2014, which is being held in Dusseldorf, Germany, from 8–14 May.