BIOQUELL Clarus L2 (609K) - APEX Laboratory Equipment Company

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Materials of external construction Temperature Operating 15°C to 35°C Storage -15°C to 50°C Relative humidity Operating Storage Top moulding – polypropylene Side panels – polyurethane coated aluminium 75% RH maximum 95% RH (non-condensing) Power requirement AC 220 – 240V 50 Hz (Euro) 6 amps AC 110 – 120V 60 Hz (USA) 12 amps AC 90 – 110V 50/60 Hz (Japan) 12 amps Power consumption Power supply Operating position Pollution degree environment 2 Dimensions (WxHxD) Weight Maximum H 2 O 2 liquid volume H 2 O 2 liquid concentration Hose pipes Gas hose connections Control system Airflow rate Gassing Conditioning/aeration Temperature of supply gas at outlet H 2 O 2 liquid injection rate Refrigeration system off coil temperature Condensate removal 1300W Installation category II Upright only 515 x 1140 x 705mm 80 kg 1 litre 30-35% w/w Bioquell hydrogen peroxide (stored at 2-8°C) 1.5 inch nominal bore male/female Camlock fittings 1.5 inch Siemens ® S7 PLC (GAMP compliant software) Controlled at 25 m 3 /hr Controlled at 25 m 3 /hr at 750Pa external pressure 75°C maximum Inlet air HEPA filter efficacy 99.997% Gassing & dehum circuit HEPA filter efficacy 99.997% Pressurisation system flow rate Pressurisation system range Noise 1.5 to 6 g/min (gassing); 0 or 1.5 to 6 g/min (dwell) Approx 2°C (from 20°C return) Evaporation to atmosphere 100 l/min (max) +200 to -200 Pa Less than 60 dBA at 1 metre (free field) Features in brief • 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 75m 3
Hydrogen peroxide vapour (HPV) technology HPV concentration 1 2 3 Inactivation of micro-organisms t=0* GASSING DWELL AERATION TIME * Conditioning phase not shown (vaporiser reaches temperature) Note: “features” on graph change e.g. depending on size of chamber (& related temperature effect) 4 5 Schematic of Bioquell HPV concentration/time graph 1. HPV introduced – initial rapid increase in HPV concentration 2. HPV saturation/“dew point” achieved – onset of rapid bio-decontamination 3. HPV gassing plateau – sustained micro-condensation effecting bio-deactivation 4. Dwell period (contact time) 5. 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 1. Injection of HPV into the enclosure starts (t=0) 2. Only slight decline in biological indicator population prior to dew point 3. 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 4. Onset of micro-condensation correlates with rapid bio-deactivation 5. Bio-deactivation achieved via micro-condensation (invisible layer) of hydrogen peroxide (2-6µm) * Typical BI: Tyvek ® pouched 6-log Geobacillus stearothermophilus spores Key benefits of HPV • Excellent material compatibility including sensitive electronics • Environmentally friendly - “residue-free” (breaks down to water vapour and oxygen) • Effective against a wide range of micro-organisms • High level disinfection achieved (6-log sporicidal reduction) HPV applications • GMP cleanrooms • Aseptic processing • Biologics • Biomedical • Biosafety/security • Material transfer chambers • Ambient decontamination of autoclaves/freeze driers • Robotic enclosures • Safety cabinets/isolators Key features and benefits of the Clarus L2 HPV generator FEATURES Optimised cycle performance producing fast and effective bio-decontamination Flexible multi-use generator Critical condition monitoring with alarm set points for ‘Alert’ or ‘Action’ Advanced software and Siemens ® PLC controls for ease of use and operation BENEFITS Minimal process downtime – no need for preconditioning, process operates with ambient environment Can bio-decontaminate rooms and enclosures up to 75m 3 . Small footprint requiring minimal floor space Compatible with GMP and GLP requirements Simple integration into a building management system (BMS) or the Clarus PORT rapid decontamination transfer chamber
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BIOQUELL Clarus L2 (609K) - APEX Laboratory Equipment Company

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