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GMP Cleanrooms

SBMC Cleanrooms

From prototype to GMP manufacturing

Accelerate your route to clinical production without investing in your own cleanroom.

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Pilot Production Facility researchers

Moving from laboratory research to clinical manufacturing is one of the most challenging phases in biomedical innovation. Access to an appropriately controlled manufacturing environment becomes essential as regulatory expectations continue to increase.

SBMC helps medtech and biomaterials companies overcome that challenge. Our Pilot Production Facility provides access to GMP Grade C (ISO 6/7) cleanrooms, quality support and technical expertise, helping organisations navigate the transition from development to clinical manufacturing within increasingly demanding GMP, MDR and quality management requirements.

Whether you're preparing for your first clinical study or expanding pilot production, SBMC offers a flexible manufacturing environment that grows with your project.

GMP Grade C (ISO 6/7) cleanrooms

Flexible rental from one cleanroom to a complete production suite

Quality Management support

High Tech Campus Eindhoven

Book your GMP consultation

A 30-minute conversation about your project and manufacturing challenges. No obligation.

Bart Sanders from research to manufacturing in a GMP cleanroom

Value is created through clinical data, not by owning a building

Bart Sanders
CEO | STENTiT

Your innovation is ready. Is your production environment?

For many biomedical companies, the next milestone isn't another laboratory breakthrough. It's moving manufacturing into a GMP-controlled environment.

Building and validating a dedicated GMP facility requires significant investment, specialist expertise and valuable time. It creates an entirely new project before production can even begin.

SBMC offers another route

Instead of building your own facility, you gain immediate access to a qualified cleanroom environment operated within an established Quality Management System. That allows your organisation to stay focused on product development, clinical validation and regulatory approval, rather than construction projects and facility management.

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Why companies choose SBMC

Building your own cleanroom isn't the only option.

For many organisations, access to professionally managed cleanroom infrastructure offers a faster and more cost-effective route  to clinical manufacturing.

Work with SBMC

Operational costs aligned with your project

Immediate access

Scale when needed

Fully managed GMP environment

Stay focused on innovation

Building your own facility

Significant capital investment

Long construction and validation

Fixed production capacity

Facility management becomes your responsibility

Infrastructure competes with your core business

The result is simple: less time spent building infrastructure and more time spent advancing your technology

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Build, rent or outsource?

Building your own cleanroom isn't the only alternative. Many companies also consider outsourcing production to a Contract Manufacturing Organisation (CMO).

A CMO is often the right choice once a manufacturing process is fully developed and ready for commercial production.

If you're still developing, validating and scaling your process, SBMC offers something different.

We provide the cleanroom infrastructure, quality support and technical services required to support GMP manufacturing activities, while your own team remains closely involved in manufacturing and process optimisation. That gives you the flexibility to keep learning, improving and preparing for the next phase of growth.

SBMC bridges the gap between laboratory research and commercial manufacturing.

SBMC

Optimised for development and scale-up

Your team remains closely involved

Room to optimise during scale-up

Designed for pilot production and clinical manufacturing

Production environment plus expertise

Traditional CMO

Optimised for established production

Manufacturing is largely outsourced

Limited flexibility for process changes

Best suited for commercial production

Production as a service

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A production environment designed for biomedical innovation

SBMC's Pilot Production Facility has been purpose-built for biomaterials, biodegradable implants, regenerative medicine and medical devices.

The facility includes:

  • Four cleanrooms designed and operated in accordance with GMP Grade C requirements (ISO 6 and ISO 7)
  • Approximately 400 m² production space
  • Dedicated Quality Control laboratory
  • Customer storage
  • Personnel and material airlocks
  • Technical rooms for equipment
  • Environmental monitoring
  • Controlled temperature and pressure, with continuous humidity monitoring
  • Utilities including Argon, Nitrogen and compressed air
  • Cleaning, gowning and facility services

Everything is designed to support the transition from laboratory research to clinical manufacturing.

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More than cleanroom space

Manufacturing is only one part of the journey.

SBMC combines cleanroom infrastructure designed to support GMP manufacturing with advanced R&D capabilities, specialised equipment and Quality Management as a Service.

Whether you need process optimisation, analytical support, manufacturing development or quality expertise, our multidisciplinary team helps accelerate your route to clinical production.

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Manufacture at the heart of the Brainport MedTech ecosystem

SBMC's Pilot Production Facility is located at High Tech Campus Eindhoven, within Cureon, the region's MedTech & BioTech innovation centre.

Here, your manufacturing activities are embedded in one of Europe's strongest biomedical ecosystems. Universities, hospitals, research institutes, technology companies and innovation partners are all within easy reach, creating opportunities for collaboration, knowledge exchange and accelerated innovation.

You're not simply renting cleanroom space. You're becoming part of an ecosystem built to move biomedical innovation forward.

Is SBMC right for your organisation?

Our facilities are designed for companies developing:

  • Medical devices and MDR-regulated technologies
  • Biomaterials
  • Regenerative medicine
  • Biodegradable implants
  • Combination products
  • Pilot production
  • Clinical manufacturing

    Whether you're an ambitious startup, an innovative SME or an established medtech company, SBMC provides production capacity that grows with your ambitions.

    We'll discuss your technology, manufacturing process and development stage, and help determine the best route towards GMP production.

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    From first conversation to first production

    1 | Discovery

    We discuss your product, manufacturing process and development goals.

    2 | Define the right production strategy

    Together we determine the cleanroom configuration, quality support and services that best fit your project.

    3 | Start manufacturing

    Move into a qualified cleanroom environment supported by established quality systems and continue developing your technology with confidence.

    Frequently Asked Questions

    Have more Questions?

    GMP Cleanroom C3Have questions? You're in the right place. Browse our frequently asked questions below to find quick answers to the topics we're asked about most.

    Can we rent a cleanroom for only a few months?

    Yes. Both short-term and long-term rental agreements are available.

    Can we use our own equipment?

    In many cases, yes. We'll assess your equipment and determine the most suitable installation.

    Do you provide GMP support?

    Yes. Besides cleanroom facilities, SBMC provides Quality Management as a Service and support with quality systems.

    Can we expand production later?

    Absolutely. Our facilities are designed to scale with your project.

    How do you protect confidential information and intellectual property?

    Customer projects are carried out under strict confidentiality agreements, with dedicated project arrangements and controlled facility access. And your cleanroom is exclusively accessible to you.

    Ready to accelerate your route to GMP manufacturing?

    ​Whether you're preparing for clinical studies, scaling your production process or exploring your manufacturing strategy, we'd be happy to discuss how SBMC can support your next step.

    Book your GMP consultation

    A practical, no-obligation conversation about your project

    Or explore SBMC first

    Download the white paper OFF

    Learn more about the facility, technical specifications and available services.

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    Take a virtual walk through the Pilot Production Facility.

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    Meet the team and experience the facility in person.