Sector Expertise
Our experience in highly controlled advanced-therapy environments is built around sterility, segregation, traceability, and contamination control; the project below demonstrates these same core engineering principles.
Cell & Gene Therapy
Specialized facility solutions for Cell Therapies, Gene Therapies, CAR-T Products, and Tissue-Engineered Medicines, designed for GMP compliance and regulatory readiness.
All Industries
Project Highlight
Implantable Medical Device & Bone Graft Manufacturing Facility
01Scope
EPC delivery of a GMP- and ISO 13485-compliant manufacturing facility for implantable cardiac devices and demineralized bone graft products for dental applications. The project included ISO Class 7/8 cleanrooms, controlled manufacturing environments, sterilization support areas, and GMP utility systems across 700 m².
02Challenge
The facility was required to support two highly regulated product categories, implantable medical devices and human tissue-derived bone graft materials, each subject to stringent controls for sterility, biocompatibility, traceability, and contamination prevention. The project also required compliance with EU MDR, ISO 13485, and applicable tissue-processing standards, while maintaining complete product integrity throughout the manufacturing lifecycle.
03Solution
Engineered segregated manufacturing suites with dedicated personnel and material flows, airlocks, pressure cascades, and HEPA-filtered HVAC systems. Implemented validated production areas for precision device assembly and bone tissue processing, including demineralization, packaging, and sterilization support operations. Integrated environmental monitoring, BMS controls, and end-to-end traceability systems to ensure compliance with quality and regulatory requirements.
04Result
Facility successfully delivered and qualified in 2014, enabling compliant manufacturing of implantable medical devices and bone graft products. The facility passed regulatory audits with zero major findings and entered commercial operations in compliance with applicable quality and regulatory standards.
