By Jim Akers, Akers Kennedy and Associates, Kazuhito Tanimoto, Shibuya Kogyo Co., Ltd., and Masahito Kawata, Handai Biken The project consists of five isolator sections: The total enclosed isolator volume for these five sections is 47.4m3. To facilitate vapor hydrogen peroxide decontamination, the isolators are divided into two sections. The first section, which consists of the isolators described in items 1-4 above, has a total enclosed volume of 30.4 m3, while the second decontamination group consists only of the fifth isolator. Decontamination is accomplished by VHPM1000S vapor phase hydrogen peroxide generators sourced from Steris Corp. (Mentor, Ohio). The isolator network is divided into two sections for decontamination in order to ensure that the total volume and surface area to be treated is within the capacity of the vapor phase hydrogen peroxide generators. The isolators are equipped with dehumidification units to reach the relatively low humidity levels required by the Steris vapor phase hydrogen peroxide generators prior to the decontamination process. Decontamination of the isolators was validated using biological indicators on stainless steel coupons with a population of 106 spores per indicator. The acceptance criterion for decontamination was complete kill of all biological indicators placed within the isolators. Following are functional descriptions of each major piece of process equipment on the line: The vial washer uses hot water for injection and, in typical washer designs, this results in the formation of water vapor under the top cover of the machine. Handai Biken engineers were concerned about the negative air pressure that would develop within the top cover. With Shibuya, they developed a double shell washer system in which positive HEPA filtered air is supplied between the outer and inner shells of the machine cover to preclude the entrainment of particulate matter from the surrounding environment. This ensures that the vials are washed
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Products & Services
Signal Isolators
Signal isolators provide electrical (galvanic) isolation between the input and output circuits. They couple the signal to the output through a transformer or optical isolator. Signal isolators also break the direct electrical (galvanic) path between two or more loop points. They are used to protect against dangerous measured-variable voltages and provide increased protection from surges and spikes.
RF Isolators and RF Circulators
RF isolators and RF circulators are passive devices used to control the propagation of an RF signal.
RF Waveguide Isolators and Circulators
RF waveguide isolators and circulators permit a signal to pass in one direction while providing high isolation to reflected energy in the reverse direction. RF waveguide circulators are passive devices with three or more ports.
UV Light Systems
UV light systems provide ultraviolet light for identification, tracing, curing, disinfection or processing applications.
Optical Isolators
Optical isolators are optical devices that allow light to be transmitted in only one direction. They are most often used to prevent any light from reflecting back down the fiber, as this light would enter the source and cause feedback problems.

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