Abstract: A microbial barrier isolation system for enclosing and decontaminating equipment so that the equipment may be used in handling or otherwise contacting biologically-sensitive materials such as parenteral solutions and solids. The barrier system is formed with a lower cavity, an upper chamber separated from the inner cavity by filters, an air return conduit, means for supplying dry, heated air to heat the system and means for using steam and hydrogen peroxide to decontaminate the internal parts of the system. The decontamination process involves using dry air to heat the internal equipment of the system to reduce water condensation and then introducing saturated steam and peroxide at a positive pressure slightly above atmospheric pressure. The internal equipment, including all surfaces, is exposed to the steam and peroxide sterilant for a sufficient time to decontaminate the equipment and the system is cooled down with cool, sterile air.

Abstract: A method and apparatus for monitoring the effectiveness of a sterilization cycle of a product that is sterilized inside a container are provided. The apparatus comprises an elongated, preferably plastic rod which is designed to extend interiorly of a container into the center or most difficult point to sterilize in the contents thereof, a reservoir located internally of the rod for receiving a sterilization sensitive agent, a means for hermetically sealing the reservoir to isolate the sterilization-sensitive agent from the contents of the container, and a mechanical means for rigidly attaching or fastening the rod to the container. The container which will usually be filled with a food or drug product, may be of conventional construction, such as a metallic can, glass or plastic bottle, or flexible package. The length of the rod is chosen such that the internal reservoir will be positioned within the slowest heating zone within the container.