Importance

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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.

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First Claim