NAME Clean room for medical device manufacturing

DESCRIPTION

ISO7 cleanroom (65 m2 ) with thermoplastic and silicone injection moulding (LSR) processes, 3D printing (FDM) prototyping equipment and bioprinter. The ISO 7 cleanroom (Class 10,000; ISO 14644-1) is an environmentally controlled facility. Using the HEPA filtration system, the air is kept particle-free at a maximum level of 352,000 particles (>0.5 microns)/m3, performing 60 air changes/hour and ensuring a positive pressure of around 20 Pa. Leartiker's monthly bioburden analyses ensure that the room is kept free of micro-organisms and particles. Leartiker obtained ISO 13485 certification in 2019, which guarantees quality management in the manufacture of medical devices under GMP (Good Manufacturing Processes) conditions. This quality system ensures that contamination is kept to a minimum in all manufacturing processes in the cleanroom, both in the development of medical devices and in scaffolding.

FIELDS OF APPLICATION

Biomedical consumables

Digital health

In-Vitro diagnostics

MOST OUTSTANDING EQUIPMENT AND COMPONENTS

  • Bioprinting

    Bioprinter: Regemat brand, Bio V1 model. This is a hybrid 3D printer, with the option of using bio-inks through extrusion and FDM printing of biopolymers. It has a modular design with the following options: bi-component syringe, heated syringe, heated bed and cooled bed.
    This bioprinter is used in the Tissue engineering research line. The scaffolds manufactured with medical grade polymers and under GMP conditions are being tested in vitro and in vivo.

  • Sigle-screw extruder

    Single-screw extruder: 3Devo brand, and model NEXT 1.0. Tabletop single-screw extruder designed for the production of thermoplastic filament for FFF printing. Production capacity: up to 3kg/hour. With a maximum working temperature of 350ºC, it can filament a wide variety of thermoplastic matrices with a target diameter of between 1 and 5 mm.
    Leartiker develops its own filaments with medical grade polymers for use in the manufacture of scaffolds for tissue engineering.

  • Silicone (LSR) injection machine

    This is a liquid silicone injection machine with a clamping force of 25 tons and an injection volume of 30 cm3; BOY brand, and E 25 VV model. The materials and paints with which the machine has been manufactured are special for use in the clean room.
    In this injection moulding machine, silicone-based medical devices are prepared under clean conditions.

  • Thermoplastic injection moulding machine

    This is a fully electric thermoplastic injection machine, with 35 tons of clamping force and a maximum injection volume of 34 cm3, ARBURG brand, and 270 A 350-70 model. The materials and paints with which the injection machine has been manufactured are special for use in the clean room.
    In this injection machine, polymer-based medical devices and POC devices are fabricated under clean conditions.

SERVICES OFFERED BY THE ASSET

Co-development of medical devices

Collaboration with hospitals, medical professionals or companies in the integral development of polymer-based medical devices: from design to functional prototype. Our main clients are hospitals, medical professionals, startups and medical device companies.

Design and manufacture of prototypes or proof-of-concepts

Design and manufacture of proof-of-concept or pre-development medical devices.

First series of POC devices.

Large-scale production of Point of Care devices: GMP injection of pre-series and samples.

Sample production, first series

GMP injection of pre-series and samples of thermoplastic and silicone-based medical devices.

ENTITY MANAGING THE ASSET

ENTITY MANAGING THE ASSET
LEARTIKER SCOOP
Contact person:
Jose Javier Egurrola Agirre
jjegurrola@leartiker.com