ISOLATOR / CLEAN ROOM: BIO-DECONTAMINATION
Applications
  • GMP cleanrooms
  • Aseptic processing
  • Biologics
  • Biomedical
  • Biosafety/security
  • Material transfer chambers
  • Ambient decontamination of autoclaves/freeze driers
  • Robotic enclosures
  • Safety cabinets/isolators
Description
Clarus L2
  • Hydrogen peroxide vapour (HPV) bio-decontamination technology, capable of 6-log sporicidal reduction
  • Fixed or mobile configurations for equipment, enclosures and rooms up to 75m3
  • Fast, validatable bio-decontamination cycles
  • PLC controlled allowing simple integration with facilities and equipment
  • Excellent material compatibility including sensitive electronics
  • Dual circuit technology for optimum cycle times
  • Closed circuit operation
  • Siemens® colour touch screen
  • GAMP compliant software
  • Compact and highly portable design
  • Easily cleanable external surface
  • Volt-free contacts for external signals
  • Integral thermal paper printer
  • Remote start/stop
  • Simple connection, flexible supply/return hoses and pressure monitoring
  • Supply return hoses (2mtrs long)
  • Cycle edit and store facility for new applications
  • Effective against a wide range of micro-organisms
  • Hydrogen peroxide vapour gas sensor
  • Utilises 30-35% w/w Bioquell hydrogen peroxide solution in 0.5 ltr or 1 ltr
  • Maximum enclosure bio-decontamination 75m3
Operation

Easy to clean and safe bottle loading mechanism with built-in drip tray and wipe clean mechanism. Housing accepts Bioquell 0.5 ltr and 1 ltr hydrogen peroxide solution allowing multiple cycles without intervention.

A thermal printer allows for hard copy data recording. Each stage of the cycle is recorded and printed.


Clarus C
  • High capacity fixed, mobile or semi-permanent configuration for enclosures and rooms up to 350m3
  • Excellent material compatibility including sensitive electronics
  • Dual circuit technology for optimum cycle times
  • Closed circuit operation – no external vent required
  • GAMP compliant software
  • Compact and highly portable design
  • Easily cleanable external surface
  • Volt-free contacts for external signals
  • Integral thermal paper printer
  • Remote start/stop
  • Simple connection, flexible supply/return hoses and pressure monitoring
  • Cycle edit and store facility for new applications
  • Effective against a wide range of micro-organisms
  • Utilises 30-35% w/w Bioquell hydrogen peroxide solution
  • Simple connection, flexible supply/return hoses and pressure monitoring
Semi-permanent configuration:
  • For room bio-decontamination without the need to enter the affected area
  • Ideal for locations which require biodecontamination or emergency bio-decontamination after a bio-spillage
  • A single HPV generator can be used to bio-decontaminate multiple discrete areas
  • HPV introduced, recirculated and monitored via proprietory gassing interface plate

Permanent configuration:
  •  For frequent and regular bio-decontamination of a room or suite of multiple rooms
  • Highly efficient distribution of HPV using rotating nozzles
  • Clarus L2 HPV generator can be located in technical space remote from area to be bio-decontaminated
  • System can be integrated with building management system (BMS)
  • Clarus L2 dedicated to area to be bio-decontaminated
  • Fully validatable for GMP facilities

Mobile configuration:
  • For infrequent or periodic bio-decontamination
  • No need for modification of room/facility infrastructure
  •  Operated via a remote control panel located outside of the area to be bio-decontaminated
  • Mobile aeration/distribution system for enhanced distribution and faster cycle times
Hydrogen peroxide vapour (HPV) technology

Schematic of Bioquell HPV concentration/time graph

  • HPV introduced – initial rapid increase in HPV concentration
  • HPV saturation/“dew point” achieved – onset of rapid bio-decontamination
  • HPV gassing plateau – sustained micro-condensation effecting bio-deactivation
  • Dwell period (contact time)
  • Aeration – removal of HPV from the atmosphere typically by catalytic conversion to water vapour and oxygen, leaving no residues
Schematic of dew point and Bioquell kill dynamics
  • Injection of HPV into the enclosure starts (t=0)
  • Only slight decline in biological indicator population prior to dew point
  • Rapid micro-biological kill occurs immediately after saturation/“dew point” is achieved – process optimised to achieve reliable 6-log sporicidal reduction on all exposed surfaces
  • Onset of micro-condensation correlates with rapid bio-deactivation
  • Bio-deactivation achieved via micro-condensation (invisible layer) of hydrogen peroxide (2-6μm)