New clean room expands capabilities for medical device components

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.”

The new ISO 7/8 clean room in Mainz, Germany, provides a controlled environment for fiber bonding and curing. Photo: SCHOTT

Smaller means cleaner

Another important trend for medical devices is miniaturization. For example, smaller light-based diagnostic devices are already making it possible to perform some medical tests in the doctor’s office rather than sending samples off to a lab for analysis.

As these devices continue to shrink, so do their optics. Many of the optics enabling advanced miniature devices have features that measure just microns, making it impossible to clean these delicate parts. Because even a tiny bit of dust can affect performance, these components must be made and assembled in a clean room where contaminants are minimized.

A cleanroom is also critical when assembling the expensive, specialty optical fibers used in the chip-manufacturing industry because contaminants can cause alignment issues.

Cleanroom capabilities

SCHOTT’s new cleanroom measures 1300 square feet and is located on the production floor in Mainz. It features state-of-the-art HEPA filters with 99.997% efficiency at 0.3 microns and 60 to 90 air changes per hour. ISO 7/8 clean rooms limit particles larger than 0.5 microns to less than 352,000 per cubic meter and must undergo ISO 14644-2 testing every 6 months to confirm operational performance.

In addition to the new cleanroom capabilities, SCHOTT Lighting and Imaging also provides high-volume serial production and medical production facilities with ISO 13485 certification registered with regulatory authorities. Partnering with us gives you access to the company’s experts who can discuss clean-room requirements and help with product development, design and prototyping, application engineering and customization.

Sep 16, 2021

Contact

Tom Bender
Lighting and Imaging
SCHOTT North America, Inc.

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