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Brand New! USP 797 Compliance for Radiopharmacuticals
Click for Larger Image The Germfree Shielded Isolator provides the ultimate in product and personnel protection. The Shielded Isolator functions as a Glovebox while operating under negative pressure to meet NIOSH recommendations while complying with USP <797> regulations for operation outside of a cleanroom. HEPA filtered unidirectional (laminar) air bathes the work area to protect the product from contamination and removes any particulates generated by sample manipulation. The operator is completely shielded from materials being manipulated in the work area. The Germfree Shielded Isolator meets or exceeds ISO 14644-1 Class 5 (Class 100) air quality under dynamic conditions. Each Shielded Isolator undergoes rigorous physical testing to assure the unit meets performance requirements. Independent certification is required before use. BZ (Benchtop Horizontal Laminar Flow Workstation)The horizontal Laminar Flow Workstation provides a high degree of localized control for critical processes. The work area is continuously bathed with positive pressure high EPA filtered air to protect product from contamination. The BZ Series of high orizontal Laminar Flow Workstations meet or exceed ISO 14644-1 / Federal Standard 209E for ISO 5 / Class 100 air and IES Recommended Practice for Laminar Flow Clean Air Devices. All units are NRTL listed with MET Labs to comply with UL1262.
LFGI (Laminar Flow Glovebox / Isolator)The Laminar Flow Glovebox/Isolator (LFGI) provides the ultimate in both product and operator protection. The LFGI functions as a Glovebox while operating under negative pressure to meet NIOSH recommendations and as an Isolator under positive pressure to meet USP <797> regulations. HEPA filtered unidirectional (laminar) air bathes the work area to protect the product from contamination and removes any particulate generated by sample manipulation. The operator is provided a complete barrier from materials being manipulated in the work area. The LFGI Series of barrier isolators meet or exceed ISO 14644-1 Class 5 air quality. Each LFGI, before shipping, undergoes rigorous physical testing to assure the unit meets performance requirements as validated. It is required that independent certification be performed before use.
Versaflow SeriesThe Laminar Flow Compounding Aseptic Isolator/Vertical Laminar Flow Workstation (VF) provides the ultimate in product protection. The VersaFlow functions as a Compounding Aseptic Isolator (CAI) while operating under positive pressure to meet USP <797> regulations. The VersaFlow can also be converted to a Vertical Laminar Flow Workstation for use in a cleanroom. HEPA filtered unidirectional (laminar) air bathes the work area and transfer chamber to protect the product from contamination and removes any particulate generated by sample manipulation. The VersaFlow Series of barrier isolators meet or exceed ISO 14644-1 Class 5 air quality. Each VersaFlow, before shipping, undergoes rigorous physical testing to assure the unit meets performance requirements as validated. It is required that independent certification be performed before use.
BV (Vertical Laminar Flow Workstation)The Vertical Laminar Flow Workstation provides a high degree of localized control for critical processes. The work area is continuously bathed with positive pressure high EPA filtered air to protect product from contamination. The BV Series of high orizontal Laminar Flow Workstations meet or exceed ISO 14644-1 / Federal Standard 209E for ISO 5 / Class 100 air and IES Recommended Practice for Laminar Flow Clean Air Devices.
BBF (Benchtop Partial Exhaust BSC)The Class II, Type A Laminar Flow Biological Safety Cabinet provides protection for the user, product and the environment from particulate and aerosol hazards. The work area is continuously bathed with positive pressure ISO 5 / Class 100 HEPA filtered air to protect product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated though the supply HEPA filter while the remaining air is discharged from the hood through the exhaust HEPA filter. The BBF Series of Vertical Laminar Flow Biological Safety Cabinets pass the Biological Tracer Containment Tests of the National Institutes of Health (NIH), the National Cancer Institute (NCI) and the National Sanitation Foundation (NSF). All units are NRTL listed with MET Labs to comply with UL1262.
BTE (Benchtop Total Exhaust BSC)The Class II, Type B Laminar Flow Biological Safety Cabinet provides protection for the user and the product from particulate, gases/fumes and aerosol hazards. The work area is continuously bathed with positive pressure ISO 5 / Class 100 highEPA filtered air while creating a negative pressure airflow into the cabinet to provide user protection. All of the air entering the hood is ducted/vented to the outside of the building. The BTE Series of Vertical Laminar Flow Biological Safety Cabinets pass the Biological Tracer Containment Tests of the National Institute of highealth (NI high), the National Cancer Institute (NCI) and the National Sanitation Foundation (NSF). |
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