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FLUIDNATEK LE-100 BioTubing: The power of making electrospun biomedical tubular structures
More infoThe Fluidnatek LE-100 BioTubing is a dedicated electrospinning platform for the coating of thin-diameter mandrels or other tubular collectors and devices, typically required in the fabrication of vascular grafts and the coating of stents, but also other electrospun medical tubular devices, such as heart valves, balloons, nerve conduits, etc. It is designed for R&D and for batch production of tubular medical devices, combining tight process control, specific features and tools oriented towards high performance depositing electrospun fibers on tubular structures, environmental regulation, and process automation in a single platform.
Built on the Fluidnatek LE-100 electrospinning platform base architecture, the BioTubing specific configuration supports reproducible biomedical electrospinning with precise control of fiber deposition, thin mandrel rotation (even below 1mm diameter with minimum wobbling), temperature and humidity, smooth emitter motion, four independent bipolar high-voltage power supplies, and in-line contactless metrology for thickness or diameter measurement. It is especially suited to research, process development, manufacturing, and validated workflows where consistency and traceability are essential.
Alongside the Fluidnatek LE-100 BioTubing, the Fluidnatek biomedical platforms range includes Fluidnatek LE-500 BioFlat for medical flat sheets, Fluidnatek LE-500 BioDevice for surface coating of geometrically complex medical devices, and the Fluidnatek ProSterile for sterile manufacturing of electrospun materials.
Fluidnatek BioTubing
Electrospinning equipment designed for the production of tubular nanofiber structures such as stents, artificial blood vessels, nerve conduits, catheters, etc.
The Fluidnatek LE-100 BioTubing is designed for precise electrospinning of tubular nanofiber structures, with the flexibility and process control needed for demanding biomedical applications.
Its specialized design and technical specifications reflect Fluidnatek’s experience in the development and production of tubular nanofiber medical devices across multiple projects.
When required, we can provide IO/OQ (Installation Qualification | Operational Qualification), and even a Performance Qualification (PQ) service upon request, supplying equipment for which a specific process has already been optimized and validated in line with established product requirements and specifications. This leads towards GMP and/or ISO 13485 certification.
Critical environmental control is supported by our Fluidnatek Environmental Control Unit (ECU), which enables precise regulation of temperature and humidity inside the spinning chamber with all degrees of freedom, and narrow deviation with respect the environmental setpoint required.
| Feature | Fluidnatek LE-100 BioTubing Specification | Why It Matters |
|---|---|---|
| Equipment Type | Dedicated electrospinning platform for stent coating, vascular graft fabrication, as well as other electrospun biomedical tubular structures | Equipment engineered based upon Bioinicia Fluidnatek’s direct experience and collaboration in several medical device developments with different biomedical companies, more specifically relating tubular medical devices, and all the learnings and insights collected are applied in the Fluidnatek LE-100 BioTubing electrospinning platform. |
| Footprint (Fluidnatek LE-100 BioTubing) | Machine: 896 mm (W) × 1240 mm (D) × 1950 mm (H) | Footprint (Fluidnatek LE-100 BioTubing) |
| Operating Modes | Both R&D and batch production of fibers (electrospinning) and/or particles (electrospraying) | Covers the full development cycle from initial process feasibility to small-batch for clinical trials, up to final medical device manufacturing, with the same electrospinning platform. |
| Batch Volume | Ability to process from 1mL to 560mL total volume of solution (up to 140 mL per syringe) | Supports short runs in early R&D stages, but also long runs in manufacturing stages (production batches). |
| Run Time | 5 min to 24 h or longer, depending on the polymer solution. Programmable auto-stop and auto-switch-off | Enables extended coating runs, including 24/7 in 3 shifts production if needed. |
| 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. |
What is the Fluidnatek LE-100 BioTubing designed for?
The Fluidnatek LE-100 BioTubing is a dedicated electrospinning platform for coating mandrels, including very thin mandrels, as well as tubular medical devices. It is used in vascular graft fabrication, stent coating, and other electrospun biomedical tubular structures such as heart valves, balloons, and nerve sheaths. The platform was engineered specifically for electrospinning on tubular structures and includes application-oriented features developed from Bioinicia Fluidnatek’s experience in projects related to electrospun coatings on tubular devices with medical device manufacturers.
What mandrel sizes can it handle?
The mandrel diameter range is from 1 mm up to 30 mm, with a maximum effective mandrel length of 400 mm.
What kind of high-voltage power supplies does the Fluidnatek LE-100 BioTubing incorporate?
It is equipped with four independent bipolar high-voltage power supplies at ±30 kV. This provides maximum versatility in voltage polarity across the different elements and systems integrated in the spinning chamber that intervene in the electrospinning process.
What batch sizes does it support?
It supports batch volumes from 1 mL up to 560 mL of total solution volume, with up to 140 mL per syringe.
What is the typical process runtime?
Run time per batch ranges from 5 min to 24 h or longer, depending on the polymer solution. The Fluidnatek LE-100 BioTubing electrospinning platform can be operated 24/7 in 3 shifts if necessary.
Is the Fluidnatek equipment suitable for validated workflows?
Yes. The machine can be provided with qualification documentation needed for ISO 13485 or GMP validation compliance. Its hygienic design and ultra-clean environment in the spinning chamber, potentially up to ISO 5 cleanliness level, make the Fluidnatek LE-100 BioTubing electrospinning platform ideal for medical device development and production.
Dedicated Medical-Grade Electrospinning for Vascular Grafts and Stent Coating
The Fluidnatek LE-100 BioTubing is designed for biomedical applications that require controlled deposition on tubular substrates, collectors or devices. Its configuration is intended for stent coating, vascular graft fabrication, and other electrospun biomedical tubular structures where stability, uniformity, homogeneity, reproducibility, repeatability and system-to-system matching are critical.
This platform reflects Fluidnatek’s experience in stent and vascular grafts electrospun coating processes, and supports the full development cycle, from initial feasibility and process optimization to batch manufacturing (regular production).
Electrospinning for Reproducible Tubular Structures
The Fluidnatek LE-100 BioTubing integrates temperature and relative humidity monitoring and regulation, actively self-regulated exhaust system, touch-screen control and process automation, advanced rotating collector platform with dual-end drive, advanced data collection for data-driven decisions, in-line contactless metrology for thickness or diameter, precise solution feeding systems, rear pin electrode, etc… These features help maintain consistency and reproducibility every time, and safe solvent removal during electrospinning of tubular structures.
Core Platform Features for Medical-Grade Nanofiber Production
The machine includes stainless steel, aluminium, and glass frame and enclosures, with a thermally insulated and chemically resistant cabinet suitable for cleanroom use. The chamber and frame are electrically earthed to help prevent charge accumulation during electrospinning.
A temperature and relative humidity sensor inside the spinning chamber displays environmental conditions in real time on the touch screen. The system also includes safety-encapsulated diffuse LED lighting and special castors for secure positioning.
Precision Mandrel Control for Stent Coating and Vascular Graft Electrospinning
The Fluidnatek LE-100 BioTubing is designed for controlled electrospinning on mandrels (including thin-diameter mandrels, e.g. < 1mm) and tubular medical devices, combining a quick-release rotating collector platform with dual-end drive to improve mechanical stability during coating. This configuration helps reduce torsional forces, minimize wobbling, and maintain accurate alignment throughout the process.
The platform supports mandrels from 1 mm (or below) to 30 mm in diameter, with a maximum effective length of 400 mm, and rotation speeds from 200 to 2000 rpm. Together with automated Y-axis positioning, X-axis scanning, and Z-axis regulation, it enables precise control of mandrel movement, emitter distance, and coating uniformity along the full substrate length.
For mandrels with diameters above 2 mm, a chuck coupling mechanism is also available. The quick-release design simplifies mandrel changeover, while the combination of controlled rotation and synchronized emitter motion supports consistent deposition, which is essential for vascular grafts, stent coatings, and other medical tubular structures requiring defined wall structure and reproducible fiber morphology.
Fluidnatek Environmental Control Unit (ECU)
The Fluidnatek Environmental Control Unit (ECU) introduces a conditioned air stream into the Fluidnatek LE-100 BioTubing chamber to regulate temperature and humidity in the spinning chamber.
Controlling temperature and humidity is critical for obtaining reproducible fiber and particle morphology and for expanding the range of materials that can be successfully electrospun.
The Fluidnatek ECU regulates temperature from 18 to 45 °C with 1 °C stability and relative humidity from 10% to 80% with 3% stability. It works in synchrony with the actively regulated exhaust system to maintain balanced airflow and stable spinning conditions.
The Fluidnatek ECU provides HEPA-filtered conditioned air and high air exchange rates from 90 to 180 m³/h, supporting cleanroom-equivalent conditions for medical and pharmaceutical device manufacturing.
The actively self-regulated exhaust system, in permanent communication with the ECU, ensures the removal of solvent vapours safely and maintain a balanced airflow, as well as high safety standards by generating a slight negative pressure.
Bipolar High-Voltage Architecture for Advanced Electrostatic Field Control
The platform includes four independent bipolar high-voltage power supplies, each providing control from -30 kV to +30 kV.
The bipolar power supplies are used for different configurations of voltage polarities applied on the emitter, the collector, the dummy collector, and the rear pin electrode.
This configuration gives the Fluidnatek LE-100 BioTubing flexibility to adapt the electrostatic fields to different applications, depending on the characteristics of the solution to be processed.
Traversing Rear Pin Electrode
The rear pin electrode traverses along the length of the mandrel in synchronization with the scanning emitter motion. With an X-axis stroke length of 450 mm, adjustable linear speed from 1 to 100 mm/s, and Y-axis position adjustment from 0 to 200 mm to adjust the distance between the collector and the rear pin electrode, it provides additional control over the electrostatic field and resulting fiber deposition, contributing to a more even deposition of electrospun fibers in determined processes.
Data Collection, Programmable Recipes, and Industry 4.0 Process Control
Over 40+ processing parameters, spinning conditions and equipment signals can be automatically recorded and displayed in real time (data and graphs), providing evidence of stable, consistent process that can be validated.
The software supports multi-user access with different privileges, database recipes, and programmable sequential multi-step recipes for process automation. Sequential programs of up to 99 steps can be created, saved, and loaded through the touch-screen interface. This helps standardize repeat processing and supports regulated workflows aligned with ISO 13485 or GMP expectations, eliminating the possibility of human errors.
Offline recipe programming is also available, allowing users to prepare recipes on a local computer or laptop and upload them to the equipment for execution.
GMP Qualification and Validation Support
The Fluidnatek LE-100 BioTubing can be can be supplied with qualification documentation for ISO 13485 or GMP validation. Bioinicia Fluidnatek can also provide on-site IQ/OQ (Installation Qualification | Operational Qualification), FAT/SAT, and optional PQ support (Performance Qualification), helping customers deploy the platform in regulated environments with documented process support for later validations according to medical standards.
Safety Features
The Fluidnatek LE-100 BioTubing is CE compliant and fulfills the corresponding EU Directives 2006/42/EC, 2004/108/EC, and 2006/95/EC.
The system is supplied with a certificate of CE compliance from an independent third-party auditor. A door interlock stops all potentially harmful processing conditions except flow rate if the door is opened during sample processing, a colour-changing warning beacon indicates machine and high-voltage status, and electrical arc detection, along with the actively regulated exhaust system and the machine protocols, make the Fluidnatek LE-100 BioTubing electrospinning platform meets high safety standards.
Optional Upgrades
The Fluidnatek LE-100 BioTubing electrospinning platform can be upgraded with optional features. These include additional high-pressure twin-channel syringe pump, solvent-gas-jacket system, audit trail function, batch control function, High-Definition Process Data Hub, remote visualization and commanding software tool for Industry 4.0, additional mandrel collectors, movable flat plate collector, mechanism for exchangeable collector platforms, and machine qualification services.
Ready to Advance Your Cardiovascular Research?
The Fluidnatek LE-100 BioTubing is designed for researchers and manufacturers who need precise, reproducible results in vascular graft fabrication and stent coating, as well as other tubular medical devices such as balloons, heart valves or nerve conduits. Whether you are defining your preliminary proof-of-concept or preparing for GMP validation in manufacturing stages, the Fluidnatek team can support you at every step of your development and manufacturing cycle.
Talk to our specialists about your needs and specific requirements for electrospun coating of your tubular medical devices, and we will help you to meet your goals.
FLUIDNATEK BIOTUBING
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