Characterization Of Single-Use BioProcess Container Systems

The trend towards single-use containers and systems in the biopharmaceutical industry has led to a shift of concerns regarding cleaning and sterilization of conventional multi-use containers and systems to those regarding material characteristics and container/content interactions. The purpose of this document is to cover these concerns and explain our approach to them.

Flexible container systems consist of plastic films, ports, tubing and fittings. Performance of a specific container system in a particular application depends on the materials and quality of construction as well as the conditions and constraints imposed by the application. The integrity of stored contents depends primarily on the characteristics of the film, the largest component of any flexible container system.