MEDICAL DEVICES
Reliable sterilization using electron beam irradiation
RADIATION STERILIZATION
ACHIEVING STERILITY IN THE FINAL STEP OF THE MANUFACTURING PROCESS
Many medical devices must be sterilized before they can be used with patients. Sterility is also essential for in-vitro diagnostics. According to the standard, a medical product is considered sterile if the statistical probability of finding a viable microorganism on or in the product is less than 1 in a million.
However, even with the greatest hygienic care and controlled production processes in a clean room, it is not possible to manufacture a sterile product. To meet sterility requirements, products must undergo sterilization after production.
One method for achieving the required level of sterilization is using electron irradiation. Through treatment using E-Beam, pathogenic germs are destroyed quickly, safely, and in an environmentally friendly manner while products are sterilized to meet standards, specifications, and other requirements.
AREAS OF APPLICATION
RADIATION & STERILIZATION OF MEDICAL DEVICES
As an external services provider, BGS supports you with the sterilization of:
- Catheters, cannulas, dialyzers, and blood tubing systems
- Dressings, wound management systems, and hydrogels
- Tubing systems for infusion, ventilation therapy, and other uses
- Surgical drapes, and instruments
- Implants and prostheses
The use of radiation-resistant materials and packaging systems is crucial for successful radiation sterilization. If your medical devices are multifunctional, consist of a variety of materials, or need to be sterile despite complicated geometric structures, we welcome the opportunity to work with you.
ADVANTAGES OF RADIATION STERILIZATION
Sterilization with ionizing radiation is one of the most common technologies for sterilizing medical devices and in-vitro diagnostics. Irradiation sterilization damages the DNA of microorganisms so they lose their ability to reproduce and eventually die.
Radiation sterilization is the only process for sterilizing products in an airtight final packaging. As a result, a significant increase in temperature, or the use of chemicals, is not necessary. Especially via E-Beam, the radiation dose can be precisely controlled and offers high reliability and reproducibility.
Another benefit of radiation sterilization is its ability to penetrate materials. After the irradiation process is complete, the applied radiation dose is checked using the dosimeters attached to the product. If everything meets specifications, our quality assurance team will immediately release it for shipment and the product is ready for immediate use. Radiation sterilization is the best choice for time-sensitive supply chains. The advantage of E-Beam over gamma irradiation is the higher product throughput rate.
CONTACT
RADIATION STERILIZATION
Are you interested in the sterilization of medical devices? We would be happy to discuss how we can assist you with the irradiation of your products.
STANDARD REQUIREMENTS
VALIDATION OF RADIATION STERILIZATION
Sterilization processes for medical devices are subject to validation. Radiation sterilization is regulated by the ISO 11137 standard. Manufacturers must demonstrate compliance to these specified requirements for the development, validation and routine control of the radiation sterilization process of their medical devices.
APPLICATIONS
IN-VITRO DIAGNOSTICS
In-vitro diagnostics occupy a unique place in the medical device sector. Because they are not used directly on patients, but instead to analyze blood, tissue, or other body substances, for example, test results must not be falsified by microorganisms contained in the sampling vessels. Therefore, sterility is essential. At BGS, we routinely sterilize:
- Pipettes and pipette tips
- Disposable syringes
- Blood collection systems
- Urine cups and stool tubes
- Petri dishes, microtiter plates, PCR trays, and reaction vessels
ADDITIONAL INFORMATION
FUNCTIONALITY
