ABSTRACT

The goal of this chapter is to provide a good design practice guideline for developing a sterile manufacturing facility. It focuses on the final formulation, filling, and finishing (initial packaging) of injectable products. Other products, such as inhalants, medical devices, and cell therapy, may be manufactured similarly to injectables, requiring a high level of integrity and protection. Thus, some of the principles and ideas presented here are applicable to those products. This chapter may help anyone who is developing a sterile manufacturing facility project to realize good design practices. It should be read in tandem with related agency guidelines and other guides, such as the International Society for Pharmaceutical Engineering (ISPE) Baseline Guide series.