New Developments in Air Conditioning Solutions for Regenerative Medical Facilities and Negative Pressure Clean Booths for Isolation
We have been providing air conditioning solutions for cell processing facilities in the field of regenerative medicine by applying the technology we have cultivated to control temperature, humidity, cleanliness, and room pressure as air quality with high precision. The system comprehensively coordinates the entire facility, including remote monitoring of cell processing equipment and air conditioning units, as well as indoor manufacturing equipment, to provide environmental and economic value to customers. We have developed a new concept, next-generation module CPC to respond the industrialization of regenerative medicine and global expansion. A variety of options such as GCTP compliance improves the QoL of society. By adopting the rotation speed control method of the FFU motor instead of the conventional air volume control using a damper and adjusting the air volume linearly, the room pressure in the preparation room can be maintained. It is also possible to control the air flow at low speed, which reduces power consumption. In addition, to promote collaboration with various companies and universities, we have established the Regenerative Medicine Innovation Center in Nihombashi, Tokyo, where you can see, touch, and simulate the equipment and devices needed for cell processing facilities.
Through collaboration with Yukaze BIO Medical, a regenerative medicine enterprise based in Okinawa Prefecture (hereinafter referred to as Yukaze BIO), we have launched the manufacturing and supply of regenerative cell medicines utilizing the latest cell culture processing facility/Cell Processing Center (CPC) and an integrated management platform for value chains.
The "Next-generation modular CPC" by Hitachi GLS, introduced in the Yukaze BIO's own factory, can ensure quality that meets global standards and has an abundant track record of implementation. Also, Hitachi's Lumada(¦1) solution, "Regenerative Medicine etc. Product Value Chain Integrated Management Platform/Hitachi Value Chain Traceability service for Regenerative Medicine (hereafter, HVCT RM)," which centrally manages information of patients, cells, and products manufactured from cells throughout the supply chain from cell collection to administration to patients, ensures the traceability of products and prevents mix-ups by allowing stakeholders such as hospitals and logistics companies to smoothly coordinate information on the cloud. Additionally, this case represents the first domestic initiative to adapt Hitachi's HVCT RM, which has a proven track record in the field of the Pharmaceutical and Medical Device Act(¦2), to the field of the Act on the Safety of Regenerative Medicine(¦3,4).
By utilizing these, Yukaze BIO will realize safe and secure manufacturing and distribution in regenerative medicine.
¦1 A collective term for Hitachi's advanced digital technologies, solutions, and services that leverage customer data to create value and accelerate digital innovation.
¦2 Pharmaceutical and Medical Device Act: Refers to the "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices."
¦3 Act on the Safety of Regenerative Medicine: Refers to the "Act on the Safety of Regenerative Medicine and Related Areas."
¦4 As of May 2023. The scope includes cell culture processing facilities that are operated in Japan under the "Act on the Safety of Regenerative Medicine."
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