The Cleanroom Solution The Biodex Germfree Portable 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> 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? USP<797> changed the way facilities that prepare compound sterile preparations (CSPs) approach their work. As the first official and enforceable requirement for CSPs, USP<797> deals with policies and practices for preparing CSPs. It applies to all facilities that prepare CSPs, including clinics, hospital care units, and main and satellite pharmacies. As facilities that prepare CSPs evaluate and change their procedures to meet USP<797> requirements, they are finding that barrier isolators provide an ideal alternative to more costly cleanrooms.