- Life & Medical Sciences
A 65 m² ISO Class 7 cleanroom equipped with thermoplastic and liquid silicone rubber (LSR) injection moulding processes, as well as equipment for prototype manufacturing using 3D printing (FDM) and a bioprinter.
The ISO Class 7 cleanroom (Class 10,000; ISO 14644-1) is an environmentally controlled facility. Its HEPA filtration system maintains airborne particle concentrations at a maximum of 352,000 particles (≥0.5 microns) per cubic metre, with 60 air changes per hour and positive pressure of approximately 20 Pa.
Monthly bioburden testing conducted by Leartiker helps ensure that the cleanroom remains free of microbial contamination and excessive particulate matter.
Leartiker obtained ISO 13485 certification in 2019, demonstrating its quality management system for medical device manufacturing under Good Manufacturing Practice (GMP) conditions. This quality system helps minimize contamination throughout all manufacturing processes carried out in the cleanroom, including the development of medical devices and scaffolds.
Equipment
- Bioprinter.
- Single-screw extruder.
- Prototyping laboratory for microfluidic devices.
- Thermoplastic injection moulding machine.
- Co-development of medical devices.
- Design and manufacture of prototypes and proof-of-concept models.
- Manufacture of samples and initial production batches.
- Initial production runs of proof-of-concept (POC) devices.
Leartiker
Lea Artibai Berrikuntza Gunea, Xemein Etorbidea 12 A, 48270, MARKINA-XEMEIN
Cleanroom Environments:
- Biomedical Engineering
- Healthcare Technologies
Application sectors
- Healthcare and medical devices
Industry plan
- HAZI · Healthcare and Biomedical Technologies
