The only single-use supplier that can manufacture everything from materials to final products in-house!
Single-use technology is widely applied in the fluid transport of both upstream and downstream processes of biopharmaceuticals. Compared to traditional stainless steel systems, single-use technology can reduce capital investment costs and has advantages such as eliminating the need for cleaning, which can accelerate research and development as well as production speed. Currently, it is widely used in various processes in fields such as vaccines, antibodies, and gene and cell therapies.
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basic information
Cobetter has extensive experience in single-use technology. Our production facility for single-use products complies with the ISO 9001: 2015 quality management system. Additionally, by referencing relevant GMP requirements, we have established 11 production lines for ISO 7 & ISO 8 and 1 production line for ISO 5, enabling us to provide solutions that meet the legal requirements for our biopharmaceutical customers.
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Applications/Examples of results
- Our proprietary Lifemeta KA film has low elution and extractables, and meets excellent chemical compatibility and biological safety standards. - It is produced with stable supply capabilities on 11 production lines for ISO 7 & ISO 8 and 1 production line for ISO 5. - We offer process validation services that meet regulations for extractables, leachables, chemical compatibility, BCT testing, and more. - Customization is available to accommodate unique designs from customers. - It meets stable quality and the requirements of GMP regulations.
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Company information
Nihon Kobetta Technology Co., Ltd. is the largest comprehensive filtration solution manufacturer in Asia. We provide a diverse lineup ranging from pharmaceutical-grade cartridge and capsule filters to single-use systems and virus removal filters, all at stable and cost-effective prices. We contribute to the stable production of pharmaceutical and medical device manufacturers around the world.