ABSTRACT
This chapter provides the practitioner with an understanding of fundamental engineering issues and available options for the filling of sterile products. The subject centers around filling equipment, not considerations such as product or packaging preparation, filtration, or the aseptic environment. The chapter focuses on high speed filling that, for the pharmaceutical industry, is typically at throughput rates exceeding 150 containers per minute for 10 ml containers. Achieving such rates requires the automation of filling and container handling. Glass vials represent the major product presentation for sterile pharmaceuticals. Vials are multiple-dose containers hermetically sealed with rubber closures. Most filling machine vendors offer monoblock machines incorporating not only filling but also rubber stoppering. Both liquid and powder products are commonly sterilized by filtration. In the case of powders, solutions are sterile filtered before crystallization, solids separation, and drying. While most of the filling machine principles discussed apply to any type of sterile product filling, some points are raised concerning aseptic filling.
