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Aseptic Processing Isolators (Presentation) by Richard L. Friedman, MS June 7, 2001
 
The highlights of this presentation by a leading FDA-CDER authority on aseptic processing isolator systems include basic design and validation approaches as well as feedback by FDA inspectors on various isolator applications during pre-approval inspections.
 
Room and Isolator Air Classification Requirements by Les Edwards, MSE, Principal Engineer 16-Apr-01
The question of what air classification is required for the inside of your isolator and the surounding room is reviewed with regard to US and EU guidelines.
 
 

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