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Fluidnatek LE-500 BioDevice: Electrospinning Platform for Nanofiber Coating of complex 3D Medical Devices
More informationThe Bioinicia Group has proven experience in the biomedical sector. We have developed projects for medical devices in which the electrospinning process played a fundamental role, and have also developed electrospinning equipment for leading biomedical companies in the development and production of electrospun medical products.
As a result of this experience, we ultimately realised that the biomedical sector required electrospinning equipment with special features that vary depending on the type of application. That is why we developed a range of equipment designed specifically for different, very specific biomedical products and applications: BioTubing®, BioFlat®, BioDevice®, and ProSterile®.
Fluidnatek BioDevice
Engineered electrospinning machine for efficient coatings on more complex medical devices and other 3D parts.
Many medical devices require electrospun nanofiber coatings to provide enhanced biological performance, controlled drug release, tissue integration, or other advanced functionalities. However, coating some particularly complex three-dimensional medical devices presents challenges that standard electrospinning equipment is often unable to address efficiently.
Through years of collaboration with biomedical companies, medical device manufacturers, and research organizations, Bioinicia Fluidnatek has gained extensive experience in the development of electrospinning processes for advanced medical devices. This experience revealed a common challenge: different biomedical applications require different electrospinning strategies, spinning arrangements, and equipment configurations.
To address these needs for the different categories of medical devices, Fluidnatek developed a dedicated family of biomedical electrospinning platforms, each platform optimized for specific applications: BioTubing® for medical tubular structures, BioFlat® for medical flat sheets, BioDevice® for coating complex three-dimensional medical devices, and ProSterile® for sterile manufacturing environments.
Advanced software tools that contribute towards the certification of a GMP or ISO process are included in the machine configuration.
Maximum process control, including of course our Environmental Control Unit (ECU) for precise temperature and humidity control in the chamber.
The Fluidnatek LE-500 BioDevice represents the culmination of this experience, providing a platform specifically engineered to deliver reproducible electrospun coatings on medical devices with particularly complex geometries by integrating a robot arm in the spinning chamber, enabling all degrees of freedom for movement of the spinning injector, while supporting scalable and validation-oriented manufacturing workflows.
| Feature | Fluidnatek LE-500 BioDevice Specification | Why It Matters |
|---|---|---|
| Equipment Type | Electrospinning platform for nanofiber coating of geometrically complex 3D medical devices and bioimplants | Developed from Bioinicia Fluidnatek’s direct experience in medical device coating projects, when using medical devices with geometries which are not easy to cover with electrospun nanofibers with more regular electrospinning equipment. |
| Footprint (Fluidnatek LE-100 BioTubing) | Machine: 1900 × 950 × 950 mm | Large chamber accommodates a wide variety of 3D device geometries, cobot arm (collaborative robot arm) configuration, and multi-axis emitter positioning setups. |
| Hygiene and chamber cleanliness | Hygienic design, ISO 7 spinning chamber (particle counting) or up to ISO 5. | Cleanroom-compatible for medical device and pharmaceutical manufacturing. Solvent-cleanable construction supports thorough cleaning between batches. |
| Positive Voltage Range for Emitter | +30kV or up to +50kV | Enables stable electrospinning across a broad range of polymer solutions. |
| Negative Voltage Range for Collector | −30kV | Independent negative HV control improves fiber deposition onto 3D collector surfaces, enhancing coating uniformity on complex device geometries. |
| Fiber / Particle Diameter | Typical range: 20 nm to 10 µm, depending on material, solution formulation, and process parameters | Covers the full morphology range of electrospun layers for vascular grafts, stents, balloons, heart valves, tubular scaffolds, and drug-eluting coatings on tubular medical devices in general. |
| User Interface | 7 in screen, 214 mm (w) × 158 mm (h). Admin and operator access levels with individual passwords | Users can control all process parameters. Multi-user access levels support regulated manufacturing workflows (ISO/GMP). |
| Solution Feeding System | High-pressure twin-channel syringe pumps | Up to 2 high-pressure twin-channel syringe pumps can be installed (for a total solution volume of 560mL). Precise, smooth solution dosing even when using highly viscous solutions, thus contributing to a tight process control when it comes to solution feeding. |
| Spinning Heads | Single-emitter spinning heads and multi-emitter spinning heads; compatible with all Luer lock needle sizes (reusable or disposable) | Fast needle changeover during R&D iteration or manufacturing batches, no tools required. Multiple needle gauges/sizes can be used, to fine tune the process. Multi-emitter spinning injectors available to increase process throughput. |
| Remote Communication | Integrated Ethernet module for remote diagnostics, and software upgrades by Fluidnatek service engineers | Minimises downtime. Enables fast remote diagnosis and software upgrades without requiring an on-site visit. Once the root cause of an issue has been found, fixing the equipment becomes much faster. The remote communication is key for this purpose. |
| Temperature and RH Display | Temperature and relative humidity (RH) sensor within the spinning chamber; real-time display on touch screen | Continuous, precise in-chamber environmental monitoring without opening the spinning chamber. |
| Rotating Collector Platform and Mandrels | Special quick-release rotating collector platform with dual-end drive for accurate rotation even when using thin-diameter mandrels (e.g. < 1mm diameter). | Dual-end drive eliminates torsional forces, minimizing possible wobbling effect; quick-release mechanism minimizes mandrel changeover time. |
| Mandrel Diameter Range | From < 1 mm up to 30 mm diameter mandrels | Covers the diameter range required for the vast majority of applications relating tubular medical devices. |
| Maximum Mandrel Length | Up to 400 mm of effective length | Accommodates standard stent lengths and short-to-medium vascular graft segments. |
| Rotation Speed | 200 to 2000 rpm | Adjustable rotating speed controls fiber alignment and coating thickness uniformity along the mandrel circumference. |
| X-Axis Automated Scanning | Stroke: 0–400 mm (±0.1 mm). Emitter linear speed: 1–100 mm/s (±1 mm/s). Syringe pumps mounted on X-axis and move simultaneously along with the spinning head | Smooth, precise scanning motion of the spinning head for both a uniform and homogeneous deposition along the full mandrel length. Pump-on-axis design eliminates flow fluctuations at slow flow rates, and the length of the tubing can be minimized (reduce dead volume). |
| Z-Axis Regulation | Range: 0–300 mm. Accuracy: 1 mm. Controlled from touch screen | Precise emitter-collector distance (spinning distance, one of the key process parameters) controlled from the touch screen without opening the spinning chamber, critical for jet stability and to avoid disturbing the environment created in the chamber. |
| Rear Pin Electrode | Traversing rear pin electrode with independent bipolar high-voltage power supply (−30 kV to +30 kV) with independent linear stage for scanning motion | Additional electrostatic field control to prevent fiber alignment artifacts on thin mandrels or to improve fiber deposition in determined processes; developed from Bioinicia Fluidnatek’s stent coating experience. |
| High-Voltage Power Supplies and Voltage Range | Bipolar high-voltage power supplies (−30 kV to +30 kV) on emitter, collector, and rear pin electrode (three independent power supplies) | Maximum flexibility regarding the voltage polarities applied over the different systems in the spinning chamber (emitters, collector, rear pin electrode), for fine process optimization. |
| Actively Regulated Exhaust System | Smart self-regulated exhaust fan for optimized solvent extraction and enhanced operational safety | The active exhaust system communicates seamlessly with the Fluidnatek Environmental Control Unit (ECU) to optimize solvent extraction and maintain a constant slight negative pressure within the chamber, preventing vapor leakage. For enhanced safety, it features an automatic shutdown protocol in the event of ventilation failure —a standard requirement for all Fluidnatek climate control units. |
| Environmental Control | Fluidnatek Environmental Control Unit (ECU). Works in synchrony with the actively regulated exhaust system | Precise, stable environmental control is critical for reproducible fibre and particle morphology and consistent batch-to-batch results. Long-term stability (±1°C and ±3% relative humidity). The Fluidnatek Environmental Control Unit (ECU) enables heating/cooling and drying/humidifying. The ECU is self-contained and can be installed in a service corridor. HEPA filtration supports cleanroom and medical device manufacturing conditions by providing an ultra-clean environment in the spinning chamber. |
| Advanced Software Functionalities | Advanced tools for data collection, process automation, equipment event management, and batch management, supporting comprehensive data integration and data-driven process runs | Providing evidence of a consistent and repeatable process is key to high-level research. The Fluidnatek High-Definition Process Data Hub facilitates this by collecting over 40+ process parameters and equipment signals, presenting them in an intuitive, personalized dashboard for total data-driven control. To complement this, the Fluidnatek Programmable Sequential Multi-Step Recipe function introduces advanced automation. This allows the equipment to run a determined process autonomously from start to finish —including time-dependent parameter adjustments— thereby eliminating the variability and errors of human intervention. Audit Trail function: Internally logs all system events and user actions during operation, ensuring full traceability required for GAMP (Good Automated Manufacturing Practices) compliance. Batch Control function: Automatically generates unique, non-overwritable batch numbers for every production run. These identifiers are linked to the data-logging system to ensure precise record-keeping for regulated manufacturing. Tampered-proof batch management is required in biomedical and pharma applications, while it’s a great nice-to-have in other applications. |
| Thickness Metrology | In-line thickness metrology system (TMS) in real-time for rotating collectors | Achieving a great thickness uniformity (flat profile all across the collector) is key to demonstrate consistency and repeatability, as well as system-to-system matching. The Fluidnatek TMS –Thickness Metrology System– is intended exactly for that purpose. |
| Diameter Metrology | In-line contactless diameter metrology (CODIM) in real-time for rotating collectors | Achieving a great electrospun layer uniformity all across thin mandrels and tubular medical devices (e.g. stents or vascular grafts) is key to demonstrate consistency batch-to-batch and repeatability, as well as system-to-system matching. The Fluidnatek CODIM –Contactless Diameter Metrology– developed to control diameter in thin mandrels and tubular medical devices is intended exactly for that purpose. |
| Compliance & Qualification | CE compliant and independently verified | Compliant with European regulations for electrical safety and electromagnetic compatibility. Moreover, IQ/OQ (Installation Qualification | Operational Qualification), and eventually PQ – Performance Qualification packages, support validated workflows in regulated pharmaceutical and medical device manufacturing environments. Compliance documentation reduces time-to-validation and supports ISO 13485 and GMP requirements. |
| Safety Features | Door interlock stops all hazardous functions on opening, electric arc detection, colour-changing warning beacon (HV status), electrically earthed chamber frame (prevents electrostatic charge), actively regulated exhaust with auto-shutdown on ventilation failure | Full protection against electrical discharge or electric arcs, solvent vapour accumulation, and unintended high-voltage exposure. Designed for safe operation in both laboratory and regulated manufacturing environments. |
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