NAME Biomaterialak eta gailu medikoak ebaluatzeko laborategia

DESCRIPTION

Biomaterialen eta gailu medikoen ebaluazio biologiko eta fisikokimikoan espezializatutako laborategia, ISO-10993 arauean oinarritutako biokonpatibilitate probak, enpresek beren produktu medikoak CE markarekin ziurtatu ahal izateko.

FIELDS OF APPLICATION

Additive manufacturing

Biomedical consumables

Electromedical devices

In-Vitro diagnostics

Laboratory equipment

Orthopedic and rehabilitation Technology

MOST OUTSTANDING EQUIPMENT AND COMPONENTS

  • Biomaterials room

    Biomaterials room (porosimeter, HPLC, lyophilizer, incubators, precision balance, micro injector, roughness meter, AFM, Raman, extrusion bioprinter, 3D stereolithography (SLA), filament FDM, pellet FDM, electrospinning, screen printing)

  • Biotechnology room

    Biotechnology room (laminar flow cabinet, climatic chamber, autoclave, incubators, precision balance, freeze drying, shaker, ultrasound bath, centrifuge, freezer, spectrophotometer, spectrofluorometer, horizontal and vertical electrophoresis, contact angle, coagulometer, stuffer, cryostat, microtome for histological samples preparation)

  • Cell-based assays room

    Cell-based assays room (incubators with CO2 control, thermal baths, biological safety cabinet, centrifuge, refrigerators, freezers, deep freezer, fluorescence microscope)

SERVICES OFFERED BY THE ASSET

Biological tests (in vitro and in vivo)

Cell-based cytotoxicity (ISO 10993-5). Irritation (ISO 10993-10). Intracutaneous Reactivity (ISO 10993-10). Sensitization (ISO 10993-10). Systemic Toxicity (ISO 10993-11). Genotoxicity (ISO 10993-3). Hemocompatibility (ISO 10993-4). Implantation Effects (ISO 10993-6)

Biomaterials characterisation

Degradation products from polymeric devices ISO 10993-13. Degradation products from ceramics ISO 10993-14. Degradation products from metals ISO 10993-15. Chemical characterisation of materials ISO 10993-18. Surface Characterisation (SEM).

Cell-based tests

Cytotoxicity tests in different cell lines. Cell Adhesion, Proliferation and Differentiation tests on different surfaces of materials. Nanoparticle uptake tests. Inflammation, Apoptosis and Cell Necrosis Tests. Molecular Tests: extraction and characterisation of DNA, RNA and proteins.

Microbiological tests

Assessment of Bioburden and Sterility (ISO 11737). Determination of endotoxins. Tests with Biocides. Antimicrobial activity of surfaces. Tests on the Adhesion and Biofilm formation on surfaces. Diffusion in agar-Antibiogram. General count of aerobic and anaerobic bacteria and fungi

Nanotoxicology (in vitro and in vivo)

Development/adaptation of toxicological test methods. Toxicological evaluation of nanomaterials. Tests for cell uptake of nanoparticles. Evaluation of the biocidal activity of nanomaterials. Biocompatibility evaluation.

Toxicology (in vitro and in vivo)

In vitro skin irritation (OECD 439). In vitro skin corrosion (OECD 404). Mutagenicity (Ames Test) (OECD 471). Mouse Lymphoma Cell Mutagenicity Assay (OECD 476). Acute oral toxicity OECD 423. Acute dermal toxicity OECD 402.

ENTITY MANAGING THE ASSET

ENTITY MANAGING THE ASSET
FUNDACIÓN TECNALIA RESEARCH & INNOVATION
Contact person:
Noelia Alvarez Luque
noelia.alvarez@tecnalia.com