Environmental Monitoring in Isolators - Time for a New Path Forward

摘要

In early 1990's when the promise of isolator technology for aseptic processing first began to be recognized and when a few bold equipment manufacturers and healthcare firms worked to implement these systems, there was no shortage.of symposia in which the validation and operation of isolators was the focus. The words "paradigm shift" were often uttered atthese meetings, almost always to enforce the idea that isolators were not merely a minor enhancement of existing aseptic processing technologies, they were instead a major departure from the manned cleanroom norm. I recall participating in an Isolator Technology User's Group ("ITUG") meeting in Raleigh, NC in 1992 in which Dr. Carmen Wagner showed a film aimed at managing changing paradigms as the technological clock ticked inexorably forward. The idea that some well-meaning individuals would express skepticism about advancing technology is not a new one, it has been part of the human experience for centuries, or more likely millennia. Quite possibly back in the day human hunters very proficient with a hurled spear were unhappy at the prospect of domesticated food sources.