Elements of Aseptic Manufacturing (Level II)

Delve into the Aseptic Processing arena with intensive hands-on instruction of aseptic techniques in a simulated cGMP environment. Instruction includes process simulations of filtrations, hand filling, semi-automated filling, release testing of final product and deviation investigations. Topics of classroom instruction include FDA regulations pertaining to Process Simulations, review of microbiology, water system review, and investigational technique. Either completion of Aseptic Manufacturing I or at least 2 years of clean room experience are recommended before enrollment in the course.

Primary Audience: Industry
Secondary Audience: Students
Primary Industry Sector:
Secondary Industry Sector: na
Program Type: Continuing Education
Lecture Hours: 16
Lab Hours: 16