We accurately measure endotoxins using techniques developed through microbial testing of medical devices!
Koga Isotope offers "Endotoxin Measurement Contract Services." Endotoxins, also known as pyrogens, can cause symptoms such as fever when they enter the human body, potentially leading to serious health issues. Our company accurately measures endotoxins using technology developed through microbiological testing of medical devices. It is necessary to consider appropriate endotoxin recovery methods for each type of medical device. Please feel free to contact us when needed. 【Contract Details】 ■ Measurement Targets: Medical devices (solid), pharmaceuticals (liquid, powder), etc. ■ Measurement Method: Optical quantitative method (turbidity method/colorimetric method) ■ Measurement Equipment: Toxinometer ET-7000 ■ Reagents Used: Limulus KY Color Series, Limulus ESII Series ■ Standards, etc. - Compliant with JP (Japan) / USP (United States) / EP (Europe) - Compliant with 21 CFR Part 11 (Electronic Records and Electronic Signatures) of the U.S. FDA *For more details, please refer to the PDF document or feel free to contact us.
Inquire About This Product
basic information
【Flow of the Examination】 ■Application ↓ ■Interference Factor Test ↓ ■Recovery Rate Measurement Test ↓ ■Endotoxin Measurement Test ↓ ■Report *Depending on the shape and properties of the sample, a lead time of approximately 2 to 3 weeks will be required. *For more details, please refer to the PDF materials or feel free to contact us.
Price range
Delivery Time
Applications/Examples of results
For more details, please refer to the PDF document or feel free to contact us.
catalog（1）
Download All Catalogs
Company information
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).
![[Free Consultation] Experts support cost reduction, DX, and on-site improvements in the manufacturing industry.](https://image.mono.ipros.com/public/product/image/2116324/IPROS15905101822341150297.png?w=280&h=280)