ABSTRACT
This chapter will address the role that the container-closure system plays in the lyophilization process and the various effects that the individual components and the combined system can have on the quality of the lyophilized product. My approach here is to first familiarize the reader with the general properties of both the closure and the container and how these properties can relate to the lyophilization process. In some instances, additional information not related to lyophilization is included. The objective for including such additional information is to make the reader aware of what components are suitable and why other components are not generally suitable for the process or product. When combined with the addition of a crimp seal, the container and closure form a packaging system that serves two important functions: (1) to protect the lyophilized product from any harmful effects of the environment and (2) to offer a convenient means for reconstituting the lyophilized formulation and delivering a sterile product.
