Expansion of medical assembly and packing services
In this interview, John Roth, Head of Sales North America Medical and Industrial at SCHOTT Lighting and Imaging, talks about the importance of the cleanroom in the manufacturing process.
Which medtech trends have you been seeing recently?
We have experienced significant growth in our core medical fiber optic lighting components business, which is primarily for reusable medical devices. Recently, we have also seen more interest from the market for the development and manufacture of disposable, single-use, and implantable devices. This class of devices must be thoroughly cleaned and sterilized during the final assembly and packaging process to avoid infecting patients and causing illness or complications during use. This means they require even more stringent manufacturing processes and cleaner environments, including bioburden controls.
Why is cleanroom manufacturing so important to SCHOTT?
We continue to invest in taking our in-house manufacturing facilities to the next level. For example, we are now equipped with certified class 10,000 or ISO Class 7/8 cleanrooms, demonstrating a strong commitment to quality and the ability to provide in-house final assembly and packaging services. Additionally, we can also work directly with sterilization partners, simplifying the whole end-to-end process for our customers.
Size: Approx. 1,800 sq. feet (approx. 170 sq. meters) with 1,300 sq. ft. (approx. 120 sq. meters) of manufacturing.
Featuring Four areas:
- ISO Class 8: Gowning
- ISO Class 7: Airlock, material pre-cleaning, and manufacturing areas
How will medtech companies benefit from these expanded capabilities?
As a manufacturing team and partner, we’re not just working on getting a product out the door, we’re working with engineering and product development teams on the prototyping and alpha and beta stages of a project. We work very closely with our customers’ design teams and are involved with the program from the beginning. As a result, we know the product intimately, making the transfer to manufacturing much more efficient. The added capability of cleanroom manufacturing and packaging, especially for disposable devices, further strengthens the realized value we can provide.
What makes SCHOTT’s medical device manufacturing capabilities unique?
We have been manufacturing medical fiber optic devices and assemblies at our site in Mexico for more than 15 years, using our proprietary core material glass. We also have an educated, diverse skill set in design and manufacturing, and we understand the life cycle of medical devices and the critical role of managing the supply chain.
In addition, we understand the importance of project schedules and speed to product commercialization, and are set up to handle all types of demand – stops, starts, and low to mid volume with anywhere from highly complex runs of five units to hundreds or thousands. These combined strengths, including ISO 13485 certification and FDA registration, set us apart in the industry and provide significant value for our clients.
Why rely on SCHOTT?
SCHOTT customers benefit from the latest technology and capabilities, resulting in an expanded service portfolio.
