Closed System Filling Technology: A New Paradigm

By James Agalloco, Agalloco & Associates, John L. Quick, Quick & Associates Inc., Leonard Mestrandrea, PhD, Mestrandrea Consulting, Inc. and David Hussong, PhD, ValSource

“Closed system filling” is a new set of processing controls appropriate for a sterile filling process that eliminates potential microbiological contamination from environmental and operator sources through the use of closed systems. This is an automated sterile connector technology by which presterilized closed containers are filled through an engineered and controlled passage enabling the filled product, the internal container and the closure system surfaces to avoid exposure to the background environment. When using this manufacturing technology, the sterile solution remains within a sterile fluid path at all times.