ISO Class 7 Clean Room Manufacturing in Brookfield, Wisconsin

STS Technical Design Earns ISO Class 7 Clean Room Certification

05 Mar 2026 Bryan Shaw

A year ago, we introduced the market to our biomedical additive manufacturing clean room.

It was a step forward for STS Technical Design and the broader STS Technical Group. A controlled environment built to support the growing demand for biomedical resin printing, clean assembly, and regulated manufacturing processes.

Today that capability has taken a meaningful step forward.

As of February 2026, the clean room inside our Brookfield, Wisconsin facility is officially ISO Class 7 certified.

That certification matters. Not because it is a badge. Because it confirms that the environment our team built and maintains meets the contamination control standards required for serious medical device and life science manufacturing.

Built for Regulated Manufacturing

Clean environments are not optional in many industries. They are foundational.

Medical device companies, life science innovators, and advanced manufacturers need partners who can support controlled production environments while meeting strict regulatory expectations.

The ISO Class 7 clean room operated by STS Technical Design supports compliance with:

  • FDA requirements
  • EU MDR regulations
  • Good Manufacturing Practice (GMP) standards

The facility follows ISO 14644 cleanroom standards, giving customers confidence that their parts, assemblies, and production workflows are handled inside a validated and controlled environment.

Just as important, this infrastructure simplifies customer audits and qualification processes. When organizations evaluate manufacturing partners, the facility matters as much as the capability.

Now both align.

Biomedical Resin Printing Inside a Controlled Environment

Inside the clean room, the STS Technical Design team supports a range of additive manufacturing and production services designed specifically for high specification applications.

These services include:

  • Biomedical resin 3D printing
  • Precision assembly within a clean environment
  • Component inspection and quality validation
  • Tyvek pouching and controlled packaging

This allows customers to move from early stage prototyping to production within a clean environment designed to support regulated applications.

For companies operating in medical, life sciences, and other high specification sectors, that continuity matters. It reduces risk, simplifies supplier qualification, and helps ensure consistent product quality.

What ISO Class 7 Certification Delivers

An ISO Class 7 clean room is designed to tightly control airborne particles and environmental contaminants.

For customers, that translates into tangible advantages:

  • Strong contamination control
  • Improved product consistency and quality
  • Alignment with global regulatory expectations
  • Access to medical and high specification manufacturing markets
  • Reduced operational and compliance risk

The certification reflects the discipline required to maintain these conditions day after day, production after production.

Progress Built Over the Past Year

When we first introduced our biomedical additive manufacturing clean room last year, the goal was clear.

Create a controlled manufacturing environment capable of supporting the next generation of biomedical additive manufacturing.

The ISO Class 7 certification represents the next step in that journey. It validates the environment our team built in Brookfield and the systems required to maintain it.

And it opens the door for a broader range of regulated production opportunities moving forward.

Supporting the Next Wave of Biomedical Manufacturing

Across the medical device and life sciences sectors, additive manufacturing continues to unlock new possibilities.

But innovation alone is not enough. Production must happen inside environments that meet strict quality and contamination control standards.

With an ISO Class 7 certified clean room now fully operational, STS Technical Design is positioned to support both prototyping and production inside a validated manufacturing environment.

For organizations seeking reliable clean room additive manufacturing capabilities, the door is open.

Clean room testing results are available upon request.