Sector Expertise
Our medical-device experience spans controlled manufacturing environments for precision products, cleanrooms, sterilization support, and traceability; the highlighted project below provides one representative example.
Medical Devices
Facility design and compliance solutions for Medical Devices, Diagnostics, IVDs, Implantable Products, and Digital Health Technologies, aligned with global quality standards.
All Industries
Project Highlight
Surgical Suture Manufacturing Facility
01Scope
Full engineering design of a 2,700 m² manufacturing facility for surgical sutures under B. Braun technology and license. The project included cleanroom design, production areas, warehousing, QC laboratories, clean and black utility systems, HVAC, environmental controls, and supporting infrastructure for medical device manufacturing.
02Challenge
Surgical sutures are Class II/III medical devices requiring stringent controls over product cleanliness, bioburden, traceability, and environmental conditions. The facility design had to support sensitive processes including suture preparation, needle attachment, cleaning, coating, packaging, and sterilization, while ensuring compliance with ISO 13485, ISO 14644, GMP principles, and applicable medical device regulatory requirements.
03Solution
Developed a fully integrated engineering package incorporating ISO-classified cleanrooms, HEPA-filtered HVAC systems, pressure cascades, controlled material and personnel flows, and qualified clean and black utility networks. The design included environmental monitoring strategies, sterilization support systems, and facility layouts optimized for contamination control, workflow efficiency, and regulatory compliance throughout the manufacturing process.
04Result
Successfully completed in 2016, providing a modern manufacturing facility designed to support high-quality surgical suture production under international medical device standards and B. Braun technology requirements.
