Environmental Monitoring System approaches for Isolator and Filling Line Systems

Synopsis

Aseptic isolators are commonly used in the pharmaceutical and life science industries in many applications, including filling lines, cell therapy processes, and sterility testing. This paper will outline some of the options and requirements that need to be considered when integrating an environmental or facility monitoring system (EMS or FMS) into these areas. It will discuss both viable and non-viable monitoring, and cover many of the aspects that need to be reviewed when producing a URS for such a system.