RA DIOP H A RMACY PORTABLE SHIELDED ISOLATOR Certified Shielded Barrier Laminar Flow Isolator • • • • • • • • • • • • • • • • • Small footprint Antechamber located under the Isolator Large, full-view shielded window Designed from the ground up for a Radiopharmacy Stainless Steel, inside and out Motorized height adjustable – 10 inch range Work sitting or standing-with correct ergonomics Meets USP Radiopharmaceuticals – Preparation, Compounding, Dispensing and Repackaging Guidelines Internal IV bar Sealed shielded dose calibrator chamber in the work surface Fits most dose calibrators Use for blood work or other compounding or drawing requirements Mobile, on four heavy-duty locking casters Electric outlets in work area HEPA air filtration Lead shielded (.25" thick) for compounding mid to low-energy sterile radiopharmaceuticals ISO Class 5 (Class 100) Isolator The Cleanroom Solution The Biodex Germfree Shielded Isolator provides the ultimate in both product and operator protection. The shielded isolator functions as a “glovebox” using negative pressure to meet NIOSH recommendations while complying with USP<797> and <825> regulations for use outside a cleanroom. 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 shielded barrier from materials being manipulated in the work area. The Biodex Germfree Shielded Isolator meets or exceeds ISO 14644-1, ISO Class 5 (Class 100) air quality. Each shielded isolator undergoes rigorous physical testing to assure the unit meets performance requirements as validated. It is required that independent certification be performed before use. What is a Barrier Laminar Flow Isolator? According to the Food and Drug Administration, a barrier isolator is “a decontaminated unit supplied with HEPA filtered air that provides uncompromised continuous isolation of its interior from the external environment, including surrounding cleanroom air and personnel.” By installing a certified barrier isolator, one can obtain cleanroom conditions within a contained workspace. Barrier isolators provide a ISO Class 5 (Class 100) environment for product preparation, with work occurring inside a closed, pressurized environment accessible only via sealed gloves that reach into the work area. A Shielded Glovebox is not a certified barrier isolator. By choosing a certified barrier isolator, the requirement for an ISO Class 8 environment is eliminated. The Biodex Germfree Isolator is an excellent example of a well-designed shielded barrier Laminar Flow Isolator, meeting all standards and more. Antechamber • Sealed two-door air lock maintains complete environmental separation between work area and ambient conditions. • HEPA filtered purge of trapped air-lock air eliminates cross contamination between the work area and the room during both material ingress and egress. Filtration • Full framed, standard size mini-pleat HEPAs filter 100% of inlet and exhaust air from both the work area and the antechamber to provide a fully contained environment. • HEPA filters are full coverage and front loading for easy replacement by a certifier. Ergonomics • Hydraulic assist height adjusting stand offers a full 10" range, allowing operators to sit or stand comfortably for extended time periods. 52 Biodex Medical Systems, Inc. • www.biodex.com