Medistri drives sharp increase in sterilisation of medical devices with integrated electronics during Research & Development phases.
• International MedTech startup’s work with Medistri for the sterilisation of their products with integrated electronics.
• Medistri’s works directly with its customers R&D teams to develop flexible sterilisation cycles during the product development phase.
• With Medistri’s EO Sterilisation Infrastructure, early-stage companies develop and then scale their sterile medical devices with integrated electronics to millions of patients worldwide.
Thanks to the advances in semiconductor, nano-manufacturing and packaging technologies, today’s medical devices are integrated with a wide range of electronic components. Start-up companies and established multinationals researching for future healthcare products containing electronic parts work with Medistri’s team to develop flexible sterilisation cycles.
Medistri’s Switzerland Plant in Domdidier is optimised to help innovative companies scale faster and remove friction to their development cycles. And many of the Medical Devices most complex and innovative products contain electromechanical parts. They can include batteries; power tools; implantable electronics, integrated circuits, stimulators; monitors; Transient electronics and authentication technologies.
For the sterilisation of medical devices with integrated electronics, Medistri’s customers whom are in their early stages of product development consider the following sterilisation technologies:
1 — Steam Sterilization Technology for Medical Devices with Integrated Electronics
2 — EO Sterilization Technology for Medical Devices with Integrated Electronics
How Medistri’s Steam Sterilization for Medical Devices with Integrated Circuits Works:
Moist heat destroys microorganisms by the irreversible coagulation and denaturation of enzymes and structural proteins. The time and temperature to accomplish this depend on pressure and the type of microorganisms to be inactivated.
After the necessary time has passed, the steam is released and the sterilized objects are removed. The entire cycle can take from 30 minutes to longer periods. Medistri’s Steam Sterilization is suited for objects that can tolerate humidity, high pressure (1 to 3.5 atmospheres above ambient), and high temperature (+121°C to +148°C). Typical examples are surgical instruments.
Semiconductor devices usually can handle up to +125°C. However, exposing embedded batteries to high temperature significantly reduces their lifetime. Memory devices that use floating-gate technology can be sensitive to high temperatures.
How Medistri’s EO Sterilization for Medical Devices with Integrated Circuits Works:
An ETO sterilization cycle consists of five stages (evacuation with humidification, gas introduction, exposure, evacuation, air washes and aeration time (removal of ETO), and its duration depends on the product type, materials, packaging and design. ETO chemically reacts with amino acids, proteins, and DNA to prevent microbial reproduction. Medistri’s EO sterilization technology is suited for objects that cannot sustain the high temperature and moisture.
Due to its low +30° to +60°C temperature conditions, Medistri’s EO sterilization process is well suited for medical devices with embedded electronics. However, the vacuum phase may bring additional study for products embedded with specific types of batteries.
Medistri has invested its resources to offer a sustainable alternative to the traditional EO sterilisation process. Medistri has introduced a smarter alternative to the market called the “Biological Indicator/ Bioburden Approach”. This approach requires that the Bioburden stays constant over time and less resistant than the biological indicators used.
The peculiarity of the sterilisation cycles at Medistri SA is to make all the phases of conditioning, sterilisation and desorption in the sterilisation unit in order to guarantee the integrity and the homogeneity of your sterilisation lot. The products that leave the chamber are ready to use.
Medistri’s smarter & intelligently designed EO sterilisation cycles can be completed within 4 days from the arrival of your products at our facilities.
There is a growing number of innovative healthcare companies that are using Medistri’s EO Sterilisation Infrastructure for the sterilisation of their medical devices with integrated electronics during early-stage R&D.
🎯 To learn more about our Sterilisation Services, visit on our website at www.medistri.swiss/en or directly contact our team at email@example.com.
— The Medistri Team