[Information] Gamma Ray Sterilization of Pharmaceuticals - Sterilization Validation and Irradiation Methods -
Introduction to the features of gamma ray sterilization, gamma ray irradiation devices, and the sterilization of pharmaceuticals using gamma rays along with their challenges.
Traditionally, the sterilization of pharmaceuticals is carried out by a series of aseptic filling machines that perform cleaning → sterilization → aseptic filling. Among these, injectable formulations such as ampoules, vials, and syringes have seen widespread adoption of filling and packaging lines, enabling mass production, and are currently used extensively. There are various sterilization methods, including steam, chemical solutions, heating, gas, and filtration. However, aseptic filling machines face challenges such as the need for sterilization during manufacturing, manufacturing time, and the scaling up of equipment. For more detailed information, please refer to the related catalog. [Contents (partial)] ■ Introduction ■ Features of Gamma Ray Sterilization ■ Gamma Ray Irradiation Equipment ■ Gamma Ray Sterilization of Pharmaceuticals ■ Challenges of Gamma Ray Sterilization *For more details, please refer to the PDF materials or feel free to contact us.
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【Other Published Content】 ■Summary ■References *For more details, please refer to the PDF document or feel free to contact us.
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Koga Isotope Co., Ltd. was established in 1981 as a contract service company for gamma-ray irradiation. We provide contract services for radiation sterilization (gamma sterilization), disinfection, and modification of polymer materials through gamma-ray irradiation. Gamma-ray irradiation contributes to health and safety in sterilization and disinfection applications for medical devices, food, and pharmaceutical packaging materials, and is also applied in the modification of polymers, leading to the development of various applications such as high-performance battery materials and water-absorbent polymers. Koga Isotope has obtained ISO 9001, ISO 13485, and ISO 11137 certifications, establishing a quality assurance system that allows customers to confidently request irradiation and microbiological testing. Additionally, we have three irradiation devices and a sterilization research center, enabling us to provide a wide range of irradiation services from low to high doses and from small to large products, as well as to examine sterilization conditions and conduct microbiological testing and training, offering total services in sterilization. Furthermore, we continuously evolve to better serve our customers by acquiring licenses for cosmetics and pharmaceutical manufacturing and introducing rapid microbial identification devices (MALDI TOF/MS).