How HYDEC systems deliver faster, more efficient decontamination for isolators, cleanrooms, and pharmaceutical manufacturing environments
Shibuya Corporation has over the last two decades developed and refined its Hydrogen Peroxide Vapor Decontamination System (HPVD). Shibuya was an early adopter of HPVD (also known as “VHP”) decontamination/sterilization systems beginning work with hydrogen peroxide as a sterilant in the early 1990’s. Out of this experience came the development of our patented HYDEC technologies which have successfully been applied to commercial aseptic processing systems for drugs, biologics, medical devices and foods. Shibuya’s HYDEC products are expertly engineered to deliver rapid, reliable decontamination or sterilization across the broadest possible range of pharmaceutical manufacturing applications from cell processing technologies to large volume parenterals. HYDEC systems have also been used in pathogen studies, microbiological laboratory operations including sterility testing. HYDEC is designed and engineered to go beyond the conventional concept of hydrogen peroxide decontamination systems, Shibuya’s proprietary flexible HYDEC process completes decontamination in short cycle times making them particularly useful for transfer of materials and components into advanced aseptic processing systems such as cRABS and isolators, while maintaining high-level sterility assurance. The fact that HYDEC can be offered in flexible built-in configurations, including both portable, fixed, and large-volume applications, allows these systems to be customized for facility layouts and process requirements. Shibuya does not just sell HYDEC systems and hope that they satisfy customer needs when installed. We test applications in house with customer systems and provide fully developed process cycles we know will be readily validated and fully reliable in the customer’s application. . These systems are designed and manufactured entirely by Shibuya to support decontamination of isolators, cleanrooms, and process chambers and our confidence is derived from having applied our HYDEC technology to many successful, regulatory approved applications .
Central to the system’s performance is its efficient decontamination process, which shortens cycle times without requiring precise control of temperature or humidity. The optimized process also allows for a substantial reduction in the amount of hydrogen peroxide required for each cycle, which provides operational efficiency and hastens aeration while maintaining effective decontamination performance. To further support reliable validation, Shibuya conducts decontamination verification and endurance testing in its in-house laboratory, where optimum decontamination cycle parameters can be established and thoroughly tested prior to factory acceptance testing.
The HYDEC series supports a broad range of applications. The HYDEC 1000 Series is suited for decontamination of isolators used in sterility testing, investigational drug preparation, hospital formulation, regenerative medicine, cell culture, and parts sterilizing chambers or transfer airlocks. The HYDEC2000 Series extends decontamination capabilities to cleanrooms and isolators used for syringe, ampoule, and vial filling, powder/liquid combination products, and the manufacture of vaccines and
protein preparations, as well as specialized environments such as animal test facilities and applications for anti-bioterrorism measures.
Backed by Shibuya’s extensive experience in pharmaceutical manufacturing systems, the HYDEC systems reflect the company’s commitment to integrated design, maximum applicability, precision engineering, thorough process suitability testing, commercial process reliability, and long-term operational performance, combined with exceptional up-time. Each system is engineered to align seamlessly with surrounding aseptic infrastructure, supporting consistent decontamination or sterilization across diverse pharmaceutical and life science environments.
For more information about Shibuya’s Hydrogen Peroxide Vapor Decontamination System and pharmaceutical manufacturing systems portfolio, visit https://www.shibuya.co.jp/en/pharmaceutical/pms04.html.