Aseptic Manufacturing Design

Module Objective:
To provide a framework for the design of an aseptic manufacturing facility in the production of pharmaceuticals.

On successful completion of this module, students should be able to:
?Present an overview of the biopharmaceutical industry and the manufacture of biopharmaceuticals.
?Identify the major design and regulatory issues associated with the design and operation of an aseptic manufacturing facility for the production of pharmaceuticals.
?Outline the implementation of a suitable sterilization, disinfection, lyophilisation regime in an aseptic processing facility.
?Design a suitable aseptic facility services and utilities including air classification, ventilation, air conditioning & HEPA filtration and water.
?Propose an outline design of an aseptic manufacturing facility which includes design philosophy, facility architecture and layout and surface finishes.
?Identify appropriate personnel clothing and procedures for working in an aseptic manufacturing environment.