コーガアイソトープ List of Products and Services

This document introduces material changes due to radiation. It includes mechanisms, effects such as strength changes, irradiation odor, and discoloration, as well as measures for using stable and unstable materials. In the radiation effects summary table, you can check the strength stability of various resins, elastomers, and metals. We encourage you to read it. 【Contents】 ■ Mechanisms ■ Effects ■ Measures ■ Summary table of radiation effects ■ References *For more details, please refer to the PDF document or feel free to contact us.

• Sterilizer
• Other contract services

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.*

• Other contract services
• Sterilizer

Currently, packaging materials are required to have high added value specifications, moving beyond the traditional purpose of simply wrapping products to include protection from external factors, preservation of freshness, prevention of corrosion, heat resistance, and gas barriers. Among these, sterilization treatment of container materials is in high demand across many fields, and further expansion of demand is expected in the future. For detailed information, please refer to the related catalog. [Contents (partial)] ■ Introduction ■ Concept of Sterilization ■ Comparison of Various Sterilization Methods ■ Sterilization Validation ■ Features of Gamma Ray Sterilized Products by Application Field *For more details, please refer to the PDF materials or feel free to contact us.

• Other contract services
• Sterilizer

The industrial use of gamma rays is being conducted in various aspects of our lives, primarily in industries such as manufacturing, healthcare, and agriculture. In particular, gamma-ray sterilization of medical devices, food packaging materials, and inspection instruments is expanding year by year. Many of these products use polymer materials as key components such as housings and lids. However, gamma-ray sterilization can cause issues such as degradation and discoloration depending on the polymer materials used. For more detailed information, please refer to the related catalog. [Contents] ■ Introduction ■ Crosslinking and Decomposition ■ Characteristics of Gamma Ray Irradiation Devices ■ Application Examples of Polymer Modification through Gamma Ray Irradiation ■ Conclusion ■ References *For more details, please refer to the PDF materials or feel free to contact us.

• Other contract services
• Sterilizer

Today, many sterile and sterilized products are manufactured in the fields of medical devices, pharmaceuticals, and food. Sterile products are often found in pharmaceuticals and food, and they are produced by maintaining a sterile manufacturing process, which requires pre-sterilized packaging materials. On the other hand, sterilized products undergo sterilization treatment after manufacturing, such as medical devices. To maintain both sterile and sterilized conditions, highly airtight packaging materials are necessary. For more detailed information, please refer to the related catalog. [Contents] ■ Introduction ■ Methods of gamma irradiation and principles of sterilization and disinfection ■ Features of gamma sterilization and disinfection ■ Current status of gamma sterilization and disinfection ■ Conclusion ■ References *For more details, please refer to the PDF document or feel free to contact us.

• Other contract services
• Sterilizer

Today's food manufacturing is conducted in hygienically managed factories, where measures against foreign matter contamination and microbial contamination are important management issues. Packaging and containers utilize materials such as polymers, metals, and natural materials (like bamboo skin and leaves) that consider the characteristics of the food. Sterilization treatments, such as gamma irradiation, are performed as necessary to prevent microbial contamination. On the other hand, microorganisms adhering to food materials cannot be inspected visually and may proliferate after the product is filled. For more detailed information, please refer to the related catalog. [Contents (partial)] ■ Introduction ■ Overview and measurement principles of MALDI-TOF MS ■ Methods for identifying microorganisms using MALDI-TOF MS ■ Future challenges ■ Examples of applications in the food industry *For more details, please refer to the PDF document or feel free to contact us.

• Other contract services
• Sterilizer

According to the Pharmaceutical Affairs Law, cosmetics are defined as products that "clean and beautify the human body." However, if cosmetics become contaminated with microorganisms, issues such as deterioration and unpleasant odors may arise, and using such contaminated products could pose a risk to human health, contrary to the definition of cosmetics under the Pharmaceutical Affairs Law. There are two types of contamination: "primary contamination," which occurs during manufacturing, and "secondary contamination," which occurs when consumers use the product. For more detailed information, please refer to the related catalog. [Contents (partial)] ■ Introduction ■ Current Situation ■ Principle of Gamma Ray Sterilization ■ Features of Gamma Ray Sterilization ■ Case Studies of Gamma Ray Sterilization *For more details, please refer to the PDF materials or feel free to contact us.

• Other contract services
• Sterilizer

In recent years, reflecting consumers' preference for natural products, many cosmetics ingredients have been derived from natural sources such as plants, soil, rocks, volcanic ash, and charcoal. On the other hand, as allergy issues have become more prominent, there is a demand for additive-free cosmetics and cosmetics with minimal amounts of antibacterial agents (artificial preservatives and disinfectants). However, natural ingredients tend to have a higher presence of microorganisms, such as soil bacteria, compared to chemically synthesized ingredients, making it difficult to reduce the use of antibacterial agents. For more detailed information, please refer to the related catalog. [Contents (partial)] ■ Introduction ■ Current Situation ■ Principles and Methods of Gamma Ray Irradiation ■ Benefits of Gamma Ray Sterilization *For more details, please refer to the PDF materials or feel free to contact us.

• Other contract services
• Sterilizer

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.

• Other contract services
• Sterilizer

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.

• Contract measurement
• Other contract services

Koga Isotope Co., Ltd. offers "small packaging and contract packaging services." We use packaging materials that have a proven track record with gamma ray irradiation. There are no limits on the number of requests; you can request from just one item. The work process will be discussed based on your product. For more details, please contact our sales department. 【Features】 ■ Can package in small quantities for each use ■ Uses packaging materials with a proven track record in gamma ray irradiation ■ Packaging tailored to needs, such as triple packaging or vacuum packaging ■ Irradiation confirmation for each package can be done by attaching chemical indicators ■ Efficient irradiation possible with cardboard boxes that fit the size of the irradiation container *For more details, please refer to the PDF document or feel free to contact us.

• Other contract services

Koga Isotope Co., Ltd. offers "Gamma Ray Sterilization and Disinfection Contract Services." Gamma rays are light (electromagnetic waves). There are no residues, and it can be used immediately after sterilization. Additionally, it resolves the issue of gas residues from ethylene oxide gas (EOG) sterilization. Our company has transactions with over 40 clients in the cosmetics industry, and we receive requests not only for final products but also for various items such as raw materials and containers. [Features] - Resolves the issue of gas residues from ethylene oxide gas (EOG) sterilization. - Gamma ray irradiation does not involve pressurization or depressurization processes, eliminating container deformation and bag breakage due to pressure changes. *For more details, please refer to the PDF document or feel free to contact us.

• Other contract services

At Koga Isotope, we offer a "Microbial Rapid Identification Service" that combines MALDI TOF-MS and genetic identification to provide quick and accurate results at a reasonable cost. To maintain sterilization assurance for medical devices, it is necessary to monitor the product's bioburden and resistance to radiation. By continuously confirming the microbial species, it becomes possible to notice changes in species and prevent sterilization failures in advance. 【Features】 ■ Combination of "MALDI TOF-MS" and "genetic identification" ■ Effective for microbial identification ■ Quick and accurate results provided at a reasonable cost ■ Supports customers' quality and hygiene management *For more details, please refer to the PDF document or feel free to contact us.

• Other contract services

The document includes a table comparing sterilization methods using gamma rays, electron beams, ethylene oxide gas, and high-temperature high-pressure steam. It also highlights the advantages of gamma ray sterilization, such as its ability to process large quantities of products evenly and the fact that they can be used immediately after treatment. 【Contents (excerpt)】 ■ Comparison of sterilization methods ・Gamma rays / Electron beams / Ethylene oxide gas (EOG) / High-temperature high-pressure steam (autoclave) ■ Advantages of gamma ray sterilization ■ Considerations for the use of ethylene oxide gas ■ Products utilizing gamma ray sterilization ■ Products utilizing gamma ray modification *For more details, please refer to the PDF document or feel free to contact us.

• Other physicochemical equipment
• others

Gamma rays are a type of electromagnetic wave (light) and can penetrate materials like X-rays. Gamma ray irradiation has the advantage of high penetration power, allowing it to be used on various product forms without harmful residues, making it immediately usable after processing. On the other hand, there are also disadvantages. Depending on the materials of the product, container, or packaging, there is a possibility of discoloration, irradiation odor, and material changes. Additionally, if irradiation is performed in an oxygen-free or frozen state, it may prevent product deterioration, so please consult us. 【Advantages of Gamma Ray Irradiation】 ■ High penetration power allows for various product forms ■ No harmful residues, making it immediately usable after processing *For more details, please refer to the PDF document or feel free to contact us.

• Other physicochemical equipment
• others

"Gamma ray irradiation" is a type of electromagnetic wave (light) that uses gamma rays, which can penetrate materials like X-rays. It utilizes gamma rays emitted from Cobalt-60. Since there are no restrictions on the packaging and materials, it is possible to irradiate at the final stage of product manufacturing, eliminating the need for strict microbial control (such as aseptic management) during the manufacturing process. Medical devices that utilize "gamma ray sterilization" include dialyzers (artificial kidneys), lancets (puncture needles), syringes, scalpel blades, sutures, and artificial joints. [Benefits of Gamma Ray Sterilization (excerpt)] - No restrictions on product forms - Usable immediately after processing - No concerns about harmful residues - Room temperature processing is possible, etc. *For more details, please refer to the PDF document or feel free to contact us.

• Other sterilization and disinfection equipment
• Other medical supplies and cosmetics manufacturing machines

"Gamma ray irradiation" is a type of electromagnetic wave (light) that uses gamma rays capable of penetrating materials, similar to X-ray imaging. Traditionally, ethylene oxide gas (EOG) sterilants and antibacterial agents have been widely used as methods for suppressing microorganisms in cosmetic ingredients. However, due to concerns about residual sterilants and the adverse effects of added antibacterial agents on the human body, gamma ray irradiation has begun to be utilized for microbial suppression in some cosmetic ingredients and final products. Additionally, gamma ray sterilization is considered to contribute to the reduction of CO2 emissions in the product manufacturing process, as it produces zero CO2 emissions during treatment. 【Benefits】 ■ No restrictions on product forms ■ Usable immediately after treatment ■ No concerns about harmful residues ■ Room temperature treatment is possible ■ Easy sterilization assurance for cosmetic products *For more details, please refer to the PDF document or feel free to contact us.

• Other sterilization and disinfection equipment
• Cosmetic materials and raw materials

Koga Isotope Co., Ltd. was established in 1981 as a contract service company for gamma-ray irradiation, providing radiation sterilization (gamma sterilization), disinfection, and modification of polymer materials. 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, with three irradiation devices and a sterilization research center, we can provide a wide range of irradiation services from low to high doses and from small to large products, as well as examine sterilization conditions and conduct microbiological testing and training, offering total services in sterilization. Furthermore, we continue to evolve to better serve our customers by obtaining licenses for cosmetics and pharmaceutical manufacturing and introducing rapid microbial identification devices (MALDI TOF/MS). For more details, please contact us or download our catalog.

• Other contract services