ABSTRACT

ISOLATORS VERSUS TRADITIONAL CLEAN ROOMS With the high cost of most new parenterals and the restrictions by the US Food and Drug Administration on sterility retests, many companies are choosing isolators over conventional clean rooms for sterility testing because of the greater environmental control. Unlike a conventional clean room, in an isolator, highly toxic surface sterilants, that is, vapor phase hydrogen peroxide (VPHP) or chlorine dioxide, can be used easily and effectively to control the microbial levels.