Delve more deeply into the aseptic processing arena with intensive hands-on instruction of aseptic techniques in a simulated cGMP environment. Instruction includes process simulations of closed-system filtrations, hand filling, semi-automated filling, LAF cabinets, BSC's and barrier isolators, and release testing of a final product. Topics of classroom instruction include FDA regulations pertaining to process simulations, review of microbiology including endotoxins, biosafety levels and water system review.
