Point of View: Isolation Technology: Looking Back and Into the Future in Healthcare Applications

摘要

Twenty five years ago, the concept of using an isolator in pharmaceutical and hospital applications was only a far out thought. The original "BUGS" (Barrier Users Group) was in its formative stages as an idea to improve sterility assurance of aseptically filled parenteral products. Containment of hazardous drugs was accomplished by putting the operator in a "space suit." By the early 1990s the pharmaceutical industry, working with the FDA, were evaluating the isolator concept as a means of not only increasing sterility assurance but reducing facility cost. Companies were testing isolation systems by running over a million vials without a single unit being contaminated. The isolators supported by effective decontamination technology through the use of vapor phase hydrogen peroxide allowed for larger batches and extended run times. The 2004 FDA guidance document "Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice" delivered to manufacturers a message that the agency not only recognized the technology, but encouraged it as a means of producing products with a higher sterility assurance level.