Room Decontamination With Hydrogen Peroxide Vapor

During the 1990s, many types of operations requiring aseptic conditions were moved from clean rooms into sophisticated glove boxes or isolators. In the pharmaceutical industry, both quality control testing and manufacturing processes have employed isolation technology. Research applications involving a need for containment of dangerous biological organisms or protection of Specific Pathogen Free (SPF) animals have also used isolation technology. In the pharmaceutical area, the predominant sterilant has been hydrogen peroxide gas (Lysfjord and Porter, 1998). The majority of these installations are using STERIS VHP ® Systems to generate the hydrogen peroxide gas. In research applications, which are most often non-GMP, manual sprays and wipe downs with sporicidal agents are common.

In some cases, it is not practical to move a manufacturing operation or research application into the confines of an isolation system, so they remain in classified clean rooms or biological safety laboratories. Periodic decontamination of these areas with a highly sporicidal gas can be desirable. In many cases, people would traditionally use formaldehyde gas as a fumigant. This paper is an attempt to categorize and review room applications that are currently using STERIS VHP 1000 series generators as their sanitizing system. Eighteen room applications are summarized. The list of applications is not all-inclusive, but provides a good cross-section of the range of uses.

In general, rooms that require periodic decontamination can be categorized by production and research applications. In most cases, production applications involve the manufacturing of sterile pharmaceuticals or medical devices in an aseptic clean room. The primary concern is the prevention of contamination of products from environmental microorganisms. Research applications usually involve work with pathogens, and the primary concerns are the safety of the researchers and the elimination of cross contamination between experiments. In some research applications, the reduction of environmental microbial contamination is also a concern such as in the care of SPF animals.