Expert Karen Holst on bright PURAVIS® glass fibers for medical technology.
SCHOTT Lighting and Imaging has added a new ISO 7/8 clean room in Mainz, Germany, to provide a controlled environment for fiber bonding and curing, optics micro-assembly and optical measurements. Such cleanrooms are critical for reducing contamination during assembly of miniature optics such as tiny microlens arrays that are difficult to clean and fiber optic components that require sterilization (e.g. ethylene oxide sterilization). With this new facility, SCHOTT is helping medical device makers develop new one-time use devices and push the limits of miniaturization.
Creating disposable devices
The trend towards one-time use devices has only accelerated with the COVID-19 pandemic. Disposable devices such as endoscopes and surgical light-guides greatly lower the risk for infection due to contamination, reduce the time and costs associated with sterilization and eliminate repairs or maintenance. Other disposable products include laser diffusers, which are used as single-use components during minimally invasive brain surgery.
Because one-time-use devices must be sterilized, clean room assembly is critical for controlling the level of contamination on the components. In these facilities, the air quality and particle size of contaminants are regularly monitored, and biological testing is used to document the bioburden — the number of bacteria living on an unsterilized surface.
“A clean room not only lowers the amount of contamination but also makes sure that it is consistent, which helps assure that the sterilization process that follows will be effective every time,” said Tom Bender, Director of Program Management at SCHOTT Lighting and Imaging North America. “Otherwise, it would be difficult to know whether the sterilization process was thorough enough to meet the needs of the product’s end use.”