We determined the recovery rate using samples and investigated suitable inoculum spores for bio-burden measurement!
In the measurement of the bioburden of sterilized medical devices, there is a spore inoculation method where known spores are applied to sterilized samples, dried, transferred to a recovery solution, physically processed to recover the spores, and the bioburden is evaluated based on the recovery rate. There are no specifications regarding the inoculated spores in ISO 11737-1:2006, and there is only an example of inoculating with B. atrophaeus spores. However, this bacterium has a low detection frequency in bioburden measurements. It is unclear which spores would be suitable for evaluating bioburden. In this study, we sought to determine the recovery rates using samples inoculated with various spores and investigated suitable inoculated spores for bioburden measurement. *For more details, please refer to the PDF document or feel free to contact us.*
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**Experimental Method (Part)** ■ Inoculation of Spores - Spores with an outer layer of spore coat - Spores with an outer layer of exosporium ■ Carrier for Inoculation - Polyethylene (PE), Polystyrene (PS), Polypropylene (PP) Polyvinyl Chloride (PVC), Polycarbonate (PC) ■ Sample Preparation - Apply spore suspension to sterilized carrier; the number of applied spores is below 100 cfu - Air dry overnight in a clean bench and use as a sample *For more details, please refer to the PDF document or feel free to contact us.*
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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).