Isolator technology. eco safe Iso Compact. Width (m) EN Isolator. Class. Standard 0.9 / 1.2 II EN

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1 Isolator technology eco safe Iso Compact Class Isolator Standard Width (m) EN / 1.2 II EN

2 Clean technology for a clean environment eco safe Iso Compact eco safe Iso Compact is an isolator system primarily conceived for the reconstitution of anti-neoplastic drugs. It works in negative pressure delivering triple protection to the operator, environment and the product as well. The gloves installed on the frontal screen provide for a physical separation of the products manipulated delivering superior safety for the operators. GloveFAST Cyto can be used as well for the handling of pathogens belonging to any group according to EN 12469:2000 and anytime the process involves the handling of cytotoxic or hazardous chemicals. The unit is equipped with triple level of HEPA filtration. can be variously used in hospital oncology centers for drugs preparation and any time an high and proven grade of protection for the operators are required. In particular, the isolator is qualified for the following applications: preparation of anti-neoplastic chemotherapies, manipulation of cytotoxic and cytostatic drugs, manipulation of etiologic agents with proven and active pathogenicity on humans and animals, handling of pathogen compounds in high concentration and mutagen agents, oncogenic virus, microbiology, virology and cell cultures recombinant DNA applications Multifunctional Keyboard Remote Control Function Time switch start/stop Speed Reduction 300 mm glove-ports Hinged front visor Stainless steel cabinet with 1 2 electrical sockdts depents on size Single piece worktray 4-Filter-System (CMR Isolator) 3-Filter-System (TPE/TPN Steril Isolator)

3 Technology of today for the world of tomorrow Air flow diagram Environment air enters into the close isolator system from the inlet H14 HEPA filter positioned on top of the unit. The HEPA filtered air is then pulled down-words in laminar flow condition prior to being filtered again by the second stage of H14 HEPA filtration. As the closed system is in negative pressure, the air is recirculated and filtered by the main H14 HEPA filters located below the work surface ( third stage of filtration ). The air is then partially recirculated into the main chamber and partially exhausted from the top where is located the fourth stage of H14 HEPA filtration. Air delivered either in the transfer hatch and the main chamber is in laminar flow conditions. Construction The body carcass is made in cold rolled epoxy painted steel painted with Alesta Dupont antimicrobial coating. The internal surfaces are made in AISI 304 stainless steel and the work surfaces as the transfer work surface, while the main chamber work surface is made in AISI 316 stainless steel Scotch Brite finishing. All the corners are smooth with 3mm radius. The whole isolator can be optionally supplied fully made in AISI 304 or AISI 316 stainless steel Scotch-brite finishing. Screens Frontal screen of the main chamber is made with a glare free safety glass 8mm thickness frontal and internal screens of the transfer hatch are made in PMMA, left and right side screens of the isolator body are made with tempered 6mm thickness glasses. The frontal screen of the main chamber can be totally opened for cleaning or maintenance purposes by means of two handles installed for this scope. A couple of gas springs keep the glass in open position whenever needed. The tightness of the frontal screen is achieved by proven-tight gasket and screws pressing the gasket. Gloves and sleeves The unit is equipped with 300mm rounded Polyethylene flanges with O-Ring system for gloves positioning. The gloves are made in neoprene material and separated by means of sleeves made in unmatched resistance textile material. Gloves and sleeves are connected with POLYETHYLENE clamps and bands. Hatch doors system Transfer hatch doors are controlled with electro-magnetic type. The external and internal doors are temporized. The internal door is made in PMMA material and the opening is enhanced with a top/down sliding system. Air flow speed Operational air flow speed is factory set to 0,40m/s both in the main and the transfer chamber. Half-speed reduction is available as well set to 0,25m/s. Alternative set-points are available upon request. Operating pressure CMR Isolator: The unit works with operative pressure set to -100Pa negative Pressure. TPE/TPN Steril Isolator: The unit works with operative pressure set to +100Pa positive Pressure. Alarms The unit automatically controls operational parameters and provide for audio and visual alarms in case of: out of range or incorrect laminar airflow velocity and internal pressure incorrect position of frontal glass saturation of HEPA filters end of life-cycle of UV lamp (if fitted) blockage in the exhaust duct fan-motor malfunction power failure Filtersystem CMR Isolator: 4-Filter-System (Supply filter, Downflow filter, Main filter and Exhaust filter) TPE/TPN Steril Isolator: 3-Filter-System (Supply filter, Downflow filter, Exhaust filter)

4 Our technology protects human and environment ECO Regelsystem (ECS) The new ECS microprocessor employs the latest innovative methods of integrated management of all the principal functions of ventilation and filtration selfregulating all the main filtration and ventilation system- components compensating for declining pressure drops and restoring power balance. Combining the use of DC motorblowers and certified low pressure-drop filters, the new ECS controlling system optimize power consumption, reducing CO2 emissions into the environment. Hardware ANTI BACTERIAL COATING low noise Stainless steel AISI 316L Real laminar flow Software Instant management and monitoring of operational parameters and automatic compensation system control by the new ECS microprocessor. Software features easily programmable replacementregime of spare parts and filters Countdown-Timer integrated within the control board. Permanent record of all alarms and anomalies memorized by the control-board for the entire life-cycle of the cabinet. One Push Restore menu, to reset the original factory calibration data. User-friendly keyboard ECS Microprocessor based monitoring system: full status report provided via 2-line digital display by the new generation microprocessors which automatically control all functions and all safety alarm systems ensuring that performance characteristics are maintained to EN12469:2000 requirements. High power lithium battery keeps safety data saved to microprocessor system. The user-friendly practical keyboard and the rear-lit LCD will continuously display all required data keeping the user constantly informed of the cabinet conditions in operation and in particular: display of laminar airflow velocity and frontal air barrier velocity display of inside and outside temperature display of residual lifetime of H14 HEPA/ULPA filters, UV Lamp (if fitted) display of total number of hours of operation display of saturation level of H14 HEPA/ULPA filters Certification ISO 9001 certified Energieverbrauch <175 W Niedrige CO2-Emission Ergonomisches Design

5 Technical specifications Description CMR Isolator Overall Dimensions W H D (1) (4) TPE/TPN Steril Isolator Overall Dimensions W H D (1) (4) Unit eco safe Iso Compact 0.9 m 1.2 m 1.5 m mm mm Useful Dimensions W D H mm Material hatch W D H mm Glove Ports mm 300 Weight kg Exhaust flow rate m3/h Noise level (2) db(a) <53 <54 <56 Lighting level lux >1100 >1200 >1300 Electrical Data 1Ph+E - 230V 50Hz Power consumption W Current consumption (2) (3) A 2,3 3,0 4,5 Electrical class / IP 1 / 20 Internal electrical outlet 6A (1) The total depth of the Isolatotr can be easily reduced to 780 mm removing the back panel (2) At operation condition according to EN12469: 2000 (3) Clean filters, lighting activated, internal outlet load excluded (4) the total high of the isolator without modular stand is 1995 mm Options and Accessories Solid Work Surface UV Light Additional Taps for Gas, Vacuum, Nitrogen Additional Electrical Outlet Hanging Bar Anti Blow Back Damper Direct Duct Exhaust Transition ATV DN 150 electrical exhaust valve for automatic decay test exhaust thimble LCD 19" touch screen in back wall Motorized stand 770 mm 1070 mm H2O2 (VHP) connections Isokinetic head for Particle monitoring RS 232, RJ 45, USB

6 Service in pure culture service in pure culture. We do not simply sell our units to you but will assist you gladly from A to Z. Delivery: We deliver all units ex works. Set-up service and packaging disposal are included upon request. Service: 24h at site service and 24h free of charge phone hotline 7 days a week Spare parts guaranty: 10 years Availability within 24h Ex stock Emmendingen Qualification: IQ/OQ GMP GAMP 21 CFR Part 11 Decontamination: We carry out microbiological decontaminations with most modern H2O2 generators in Cleanrooms, Isolators and Safety Cabinets. Maintenance: Microbiological Safety Cabinets DIN Cytotoxic Dispensing Cabinets with KI-discus test DIN Laminar Flow Cabinets Laboratory Fume Hoods Cytotoxic Dispensing Isolator EN Isolator EN Cleanrooms Autoclaves CO2 Incubator PCR Thermal Cycler Real Time Thermal Cycler Centrifuge Water purification Ultra Low Temperature Freezer -86 C Service by professional staff. All works are carried out by service technicians qualified by TÜV Nord Maintenance contract: Regular terms of maintenance increase your safety. With a maintenance contract we guarantee the complete check of all functions of your units. We will contact you reliably in regular terms. Guaranty and Warranty: Combined with an maintenance con-tract we offer a 2-year warranty to all units. Excepted are consumables and wearing parts as well as compressed air components. Legend: TÜV-tested Work zone rear wall varnished Hinged front visor for optimal cleaning Media connections installed electrical sockets installed Stainless steel work zone rear wall Ergonomic Low power consumption /01