SBMC’s Pilot Production Facility (Cleanrooms)

The SBMC’s cleanroom facility is situated in a multi-tenant building on the High Tech Campus in Eindhoven, The Netherlands. The facility includes a cleanroom area, storage rooms (23 – 30 m2) and a QC laboratory.

The cleanroom area (see floorplan) consists of a central, controlled not-classified (CNC) corridor, which is accessible for personnel via a consecutive shared gowning area, and for materials and/or equipment via a shared material airlock. All cleanroom areas can be accessed from the central CNC corridor. Each of the four cleanroom production areas is reachable via two dedicated consecutive personnel air locks.

A technical room is located between two adjacent cleanrooms, providing space for production area-related, external equipment. Cleanrooms 1 & 4, and 2 & 3 can be directly connected when desired. Cleanroom production areas are temperature controlled, and relative humidity is monitored.

Utilities and fixed equipment
Cleanroom 1 (58m²) is equipped with: 2 fume hoods with Argon 5.0, Nitrogen 5.0, and compressed air.
Cleanroom 2 (43m²) is equipped with: 1 fume hood with Argon, Nitrogen 5.0, and compressed air.
Cleanroom 3 (53m²) is equipped with: 1 fume hood with Argon, Nitrogen 5.0, and compressed air.
Cleanroom 4 (112m²) is equipped with: 2 fume hoods with Argon, Nitrogen 5.0, and compressed air.

Additional gas connections can be installed in the ceiling utility panels of each cleanroom production area. For gases other than Argon 5.0 and Nitrogen 5.0, an appropriate source and solution can be assessed. Additional air extraction from process equipment was foreseen in the cleanroom design and can be constructed specifically in accordance to customer requirements.

Development Laboratory

In addition to the cleanroom facilities, SBMC provides access to a development laboratory supporting biomaterials and tissue engineering R&D. This laboratory offers access to specialized equipment and workflows, including:

• Confocal and epifluorescence microscopy
• Electrospinning (Vivolta EC-CLI)
• Scanning Electron Microscopy (SEM + EDX)
• Mechanical and material characterization (tensile tester, rheometer)
• Automated pipetting systems
• Biocompatibility and tissue processing workflows
• Histology line

Link: Contract Research and Development Services at SBMC

SBMC’s cleanrooms are located in Cureon, the MedTech & BioTech innovation center at High Tech Campus Eindhoven. Cureon connects SBMC’s Pilot Production Facility with a thriving regional ecosystem:

• Access to universities, hospitals, and research institutes
• Funding opportunities for SMEs and consortia
• Shared infrastructure, talent, and innovation partners all in one place

Smart BioMaterials Center is a partner in the national collaboration “RegMed XB Pilot Factory for Regenerative Medicine” and has a collaboration agreement with the founding institution, Eindhoven University of Technology, providing easy access to leading scientific knowledge and expertise.

Environmental monitoring
SBMC uses a standalone qualified Rotronic Monitoring System. Differential pressure is continuously monitored in all cleanroom areas. Temperature and relative humidity are monitored in the cleanroom production areas, QC-laboratory, and the storage areas.

Access control
Access to the airlocks leading into the cleanroom production areas and storage area is restricted by using badge readers.

Gowning and operational services
SBMC supports cleanroom operations through a range of services. Standard services include pest control, waste management, and environmental monitoring.
Additional services, such as gowning, cleanroom cleaning, and microbiological (bioburden) monitoring, can be provided upon request and may incur additional costs.

Storage rooms
In addition to the cleanrooms, SBMC offers secure storage facilities for raw materials and finished products. These areas are access-controlled via badge readers and equipped with temperature monitoring to ensure appropriate storage conditions. Pest control measures are in place to protect stored materials.

QC laboratory
SBMC provides access to a QC laboratory space to support in-process controls. The laboratory includes basic infrastructure such as a fume hood and chemical storage, allowing companies to perform selected quality control activities in line with their specific requirements.

Quality as a Service
SBMC provides Quality Management as a Service (QMaaS) to support companies in developing and scaling their products in line with regulatory expectations. From early development to clinical readiness, they help translate technical decisions into structured, compliant documentation.

Their support includes:
QMS blueprints: Pre-structured quality systems tailored to your development phase
ISO 13485:2016 alignment: Guidance on implementing and maintaining compliant processes
Regulatory integration: Embedding quality and risk management into your development workflow