IonHP ion-decontamination system proven to achieve greater than 6 log reduction in bioburden for a fully laden SAS in under two hours
Two Safety Airlock System (SAS) units with volumes of more than 5m3 have been designed and manufactured by Telstar, to be installed between two zones with different grades in the aseptic manufacturing facility of animal health product manufacturer Virbac.
Each of the units is fitted with integrated ionHP (ionised hydrogen peroxide) biodecontamination systems. Although the company has experience in the installation of biodecontamination systems into isolators, it has now successfully adapted this type of system for use in a SAS for transference of materials into aseptic installations.
The SAS units were developed in Dewsbury in the UK by the Technology Centre for Barrier Isolation Systems within Telstar, and are designed to sanitise materials that are not suitable for sterilisation by other methods. They are capable of biodecontaminating a fully laden unit in less than two hours while achieving a log 6 reduction in bio-burden, validated using a Bio-indicator (BI) Challenge. The 2-hour cycle duration is inclusive of aeration down to a level of <2ppm H2O2 while working independently to the facility’s HVAC system.
Telstar biodecontamination pass-through chamber loading in a cleanroom
Using the innovative integrated ionHP biodecontamination systems was a key factors for the transfer systems as they provide cost-effective and efficient biodecontamination with reduced cycle times when working independently to the facility’s HVAC system.
Reduced cycle times are achieved because the ionHP bio-decontamination efficiency is not affected by temperature and humidity and thus the need to pre-condition the chamber prior to injection is eliminated. The method of injection causes immediate disassociation of the liquid solution to produce hydroxyl radicals, ROS, O3, RNS, Plasma, UV and heat activation, providing synergistic effects of multiple antimicrobials.
Finally, the EPA-registered sterilant used has a lower concentration of H2O2; 7.5% compared with conventional vapour-phase io-decontamination systems, which can be as high as 30-35%. This reduced concentration improves material compatibility and sterilant usage is reduced, giving savings in operational costs for sterilant consumption.
'The project proved to be very rewarding, involving Telstar’s Project Management Team working alongside the client to meet their specific requirements,' said Warren McFee, Engineering Manager at Telstar UK.