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Build your own cleanroom and you size it once, years before you know what the process will need. Renting keeps the capital, the timeline and the capacity open. GMP Grade C rooms at High Tech Campus Eindhoven, ready to use.

Designing, building and qualifying a GMP cleanroom takes years, and the capacity is fixed before your programme is. These four rooms are finished. Grade C, ISO 6 and 7, 43 to 112 m2 at High Tech Campus Eindhoven.

Outsourcing to a CDMO means handing your process to people who have to learn it first. Rent a GMP cleanroom instead and nothing is transferred. Your methods, your operators, your batch records. Grade C, ISO 6 and 7, at High Tech Campus Eindhoven.

🔬 Your cleanroom. Without owning one. Build your own cleanroom or outsource production? For medtech companies moving towards clinical production, those can seem like the only two options. But there is a third: rent GMP cleanroom capacity and keep production in your own hands. Your own people stay with the process, your know-how and IP remain in-house, and you use production capacity when you actually need it. Without the investment and lead time of building your own facility. That flexibility matters, especially when production needs are still evolving. At SBMC, we offer GMP Grade C cleanrooms (ISO 6 and 7) at High Tech Campus Eindhoven for exactly that phase. It won’t be the right solution for everyone. But it may be worth considering before deciding whether to build or outsource. Book a 30 minute conversation with our QA manager. Link in the comments.

Scaling to GMP production means working out which rules actually apply to your product. A medical device and a medicinal product take different routes. Our quality team walks yours with you, in rooms that are already qualified.

Building your own GMP facility starts an entirely new project before production can begin. Ours is finished. Qualified, monitored and maintained inside an established quality system, Grade C, ISO 6 and 7. You bring the process.