ClarusTM PORT Rapid Gassing System suitable for ENVAIR Isolators
The industry has identified a need to achieve very rapid bio-decontamination cycles for small loads for aseptic processing in isolator enclosures as the time for surface decontamination of product enclosures is a rate limiting factor for overall processing capacity.
A configuration has been identified where a rapid decontamination chamber attached to process isolators can maintain continuous processing capacity by achieving at least two load decontamination cycles per hour, providing the load represents at least one hour of processing time. In recognition of this Bioquell has developed the Clarus PerOxide Rapid Transfer (PORT) System to fulfil these processing requirements.
The Clarus PORT can also be used as a double-ended rapid bio-decontamination pass through chamber to surface sterilise and transfer materials into cleanrooms.
The PORT System bio-decontamination chamber is manufactured from stainless steel with toughened glass doors and vision panels.
The unit has a full front glass opening panel which is hinged upwards and secured on gas struts to assist with opening and closing. Each end of the chamber is fitted with a circular door on an interface housing onto which an isolator can be attached. The rear of the chamber is fitted with a fixed glass panel to provide light from the room and to provide vision through the chamber. Within the gassing chamber is located a product load trolley mounted on a rail system which can transfer either to the left or right for unloading.
Above the decontamination chamber is mounted the gas distribution system comprising the unique active rotating distribution nozzle and the control system and display panel. The ventilation system is housed below the chamber. Supply and exhaust air is fully HEPA filtered. A catalytic filter system is fitted on the exhaust air from the chamber to remove all traces of hydrogen peroxide vapour before the air stream is then HEPA filtered and supplied back into the chamber. A separate diaphragm pump is used for pressure control of the chamber during the aeration phase until the sterilised load is transferred into the isolators.
The doors are clear toughened glass with an inflatable seal around the perimeter to ensure a full air seal and also to act as an interlock when the door is closed. In addition the door has a mechanical latch that will prevent accidental opening of the door in the unlikely event of loss of compressed air supply.
The gas generator (Clarus L2) is normally located at one end of the chamber. It is connected to the PORT System by gas supply and return hoses, a communication cable and chamber pressure sensor hose. The operation of the Clarus L2 generator controls and the PORT System are fully integrated when the generator is docked. Cycle status is displayed on the PORT controls, together with any warning or alarm condition. All generator commands are displayed at the generator and printed reports are output on the gas generator printer. The sterilisation cycle can be initiated either from the gas generator or from the PORT control panel.