Expansion of medical assembly and packing services

To support the growing demand for the manufacture of complex reusable and single-use medtech devices, SCHOTT is expanding its medical assembly and packaging services at its state-of-the-art production site in Mexico. Our new bioburden-controlled, class ISO 7/8 cleanroom was inaugurated in May 2023.

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.

In the past years, SCHOTT Lighting and Imaging experienced significant growth in its core medical fiber optic lighting components business, which is primarily for reusable medical devices. Recently, the medical team has 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.

The importance of cleanroom manufacturing

SCHOTT continuously invests in taking its 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..

The new bioburden-controlled cleanroom at SCHOTT Lighting and Imaging in Mexico supports the growing demand for our customers' medical assembly and packaging services.

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
Two people manufacturing lighting products in the cleanroom in Mexico
Manufacturing lighting products in the cleanroom in Mexico

More benefits for medtech companies

As a manufacturing team and partner, SCHOTT is 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, the SCHOTT team knows 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.

Unique medical device manufacturing capabilities

SCHOTT Lighting and Imaging has been manufacturing medical fiber optic devices and assemblies at our site in Mexico for more than 15 years, using the company’s 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.

Want to know more? Let’s talk

Whether you need more information, samples, a quote, or advice for a project, we would be delighted to talk to you.

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