ABSTRACT
INTRODUCTION This chapter reviews key concepts and principles in the design and development of a sterile (aseptic) processing facility project. It reviews the development of sterile injectable products as well as describes some broad and underlying principles in practice today. Comparisons are made between open and closed process unit operations, typical engineering discipline practices, as well as implications of compliance on projects and operations. Finally, key elements and considerations in the development of a sterile manufacturing facility are presented, along with commonly accepted terms, ideas, and future trends.
