CDMO for medical textiles: fibers, braids and implant textiles from material development through ISO 13485 manufacturing.
ITA medical GmbH & Co. KG
Aachen · GermanyNew on Amplifa
About ITA Medical
ITA medical GmbH & Co. KG is an ISO 13485-certified Contract Development and Manufacturing Organization (CDMO) for medical textiles headquartered in Aachen. The company develops and manufactures implantable textiles, surgical meshes and biomaterials – from material development and prototype building through to scalable series production. The technologies include melt and solution spinning (mono- and multifilaments, bicomponent fibers, co-extrusion from 30 g batch size), electrospinning of nanofibers (100–5000 nm) as well as braiding, weaving and warp knitting of 2D and 3D structures. Processed materials include biodegradable polymers such as PLA, PLGA, PCL, P4HB and PLLA, non-degradable polymers such as PET, PVDF and TPU, as well as metals such as Nitinol, magnesium and stainless steel. Application fields include cardiovascular and neurovascular devices, general surgery, orthopedics and tissue engineering. Production takes place in cleanroom capacities; the company works closely with the ITA – Institut für Textiltechnik of RWTH Aachen.
- Site
- Aachen
- Processes
- Fiber Spinning (Melt & Solution Spinning, Mono/Multi, Co-extrusion), Solution Spinning, Electrospinning (Nanofiber, Nonwoven, Coating), Braiding (Flat, Tubular), Weaving (Flat, Tubular / Shuttle, Needle), Knitting (Warp knitting: Flat, Tubular, 3D, Spacer), Yarn & Fabric post processing (Air & False Twist Texturing, Coating), Shape Forming (Alloys e.g. NiTi & Polymers e.g. SMPs)
- Materials
- Polylactic acid (PLA), Poly(lactic-co-glycolic acid), Polycaprolactone, Poly(4-hydroxybutyric acid), Poly(L-lactide), Polyvinylidene fluoride, Thermoplastic Polyurethane, Polyethylene terephthalate
- Certificates
- ISO 13485
- Industries
- Medical technology, Cardiovascular devices, Neurovascular, Orthopedics, General surgery, Tissue engineering
- 01
Material development and material selection
- 02
Fiber production (melt/solution spinning, electrospinning)
- 03
Textile structure formation (braiding, weaving, warp knitting)
- 04
Post-processing and shaping (texturing, coating, shape forming)
- 05
Prototype building and testing
- 06
ISO 13485 manufacturing incl. regulatory support
Sites
Aachen
DEProduction, development, cleanroom manufacturing, sales
- Lot size
- Small series to large-scale production; fiber spinning from 30 g batch size
- Materials
- Biodegradable and non-degradable polymers, metals (NiTi, Mg, stainless steel)
- Co-extrusion melt spinning plant (2 extruders, 1 kg/h and 3 kg/h)
- Co-extrusion solution spinning line (5.8–216 g/h, air gap 0–500 mm)
- Electrospinning equipment (0.1–2 L, 1–24 nozzles, climate-controlled)
- 2D circular braiding machine (up to 60 bobbins, mandrels 0.3–100 mm)
- Hexagonal 3D braiding machine
- Endless-spiral braiding automation
- Narrow needle loom (10–2200 dtex)
- Narrow loom with Stäubli Jacquard machine
- Double-face Raschel warp knitting machine
- Jacquard Double Needle Bar machine
- Spacer Fabric Double Needle Bar Raschel machine
- Cleanroom production areas
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Fiber Spinning (Melt & Solution Spinning, Mono/Multi, Co-extrusion)Plastics | – | Air-gap spinning 0 - 500 mm | 30 g (small batches) | 30 g | PLA, PLGA, PCL, P4HB, PLLA, PVDF, TPU, PET, SMP, Polyamide, UHMWPE, PP, Hyaluronic acid (HA), Caterpillar silk, Nitinol (NiTi), Magnesium (Mg), Stainless Steel |
| Solution SpinningPlastics | – | Air-gap 0 - 500 mm | – | – | Thermo-sensitive polymers |
| Electrospinning (Nanofiber, Nonwoven, Coating)Plastics | Fiber diameters 100 nm - 5000 nm | – | – | 0.1 L – 2 L | PLA, PCU, broad range of processable materials |
| Braiding (Flat, Tubular)Forming | Braiding mandrel diameters 0.3 - 100 mm | 0.3 - 100 mm | – | – | Nitinol, PET, PTFE, PGA, PLA, PCL |
| Weaving (Flat, Tubular / Shuttle, Needle)Forming | – | – | – | – | PCL, PVDF, TPU, PET, UHMWPE |
| Knitting (Warp knitting: Flat, Tubular, 3D, Spacer)Forming | – | – | – | – | PCL, PVDF, TPU, PET, UHMWPE |
| Yarn & Fabric post processing (Air & False Twist Texturing, Coating)Surface treatment | – | – | – | – | – |
| Shape Forming (Alloys e.g. NiTi & Polymers e.g. SMPs)Forming | – | – | – | – | NiTi, SMP |
| Finishing (Embroidery, Sewing)Joining | – | – | – | – | – |
| Material Development and Selection (biodegradable/biocompatible polymers)Engineering | – | – | – | – | Biodegradable and biocompatible polymers |
| Prototype Design and TestingEngineering | – | – | – | – | – |
| Regulatory Support (ISO 13485 certification and compliance)Engineering | – | – | – | – | – |
| Scalable Manufacturing (small batches to full-scale production)Assembly | – | – | – | – | – |
| Covering and CoatingSurface treatment | – | – | – | – | – |
| Scaffold Design (2D and 3D textiles, mechanically and morphologically tailored systems)Engineering | – | – | – | – | Non-Degradable and Degradable Materials |
12 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Co-extrusion spinning plant (Melt Spinning) | – | 1 | Two extruders 1 kg/h and 3 kg/h throughput; mono- and multifilaments; bicomponent fibres | – | Aachen |
| Co-extrusion Solution Spinning line | – | 1 | Throughput 5.8 g/h – 216 g/h; air-gap 0 - 500 mm; production velocity 5 - 50 m/min | – | Aachen |
| Electrospinning equipment | – | – | Sample volume 0.1 - 2 L; throughput 0.01 - 10 mL/h, 1 – 24 nozzles; climatized conditions | – | Aachen |
| 2D-Circular braiding machine | – | – | Up to 60 bobbins; mandrel diameters 0.3 – 100 mm | – | Aachen |
| Hexagonal 3D braiding machine | – | – | – | – | Aachen |
| Single wire braiding automation | – | – | – | – | Aachen |
| Narrow Needle Loom | – | – | Linear densities 10 to 2200 dtex | – | Aachen |
| Narrow Shuttle Loom with electronically tension controlled shuttle and Stäubli Jacquard machine | Stäubli (Jacquard) | – | Linear densities 10 to 2200 dtex | – | Aachen |
| Double-face Raschel warp knitting machine | – | – | 2D and 3D structures, spacer fabrics, meshes, tubular structures | – | Aachen |
| Jacquard Double needle bar machine | – | – | – | – | Aachen |
| Spacer Fabric Double needle bar raschel machine | – | – | – | – | Aachen |
| Premium clean room production facilities | – | – | – | – | Aachen |
Additional services
Quality
The quality management system is certified to ISO 13485; the manufacturing of medical products takes place in cleanroom capacities. The company additionally supports partners with certification and regulatory compliance.
| Evidence | Aachen |
|---|---|
| ISO 13485 |