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Fluidnatek LE-500 BIOFLAT Platform: Medical Flat Sheets Production
More informationThe Fluidnatek LE-500 BioFlat is an LE-500 electrospinning platform specifically configured for medical flat sheets production, with high process control. It combines roll-to-roll collector with conveyor belt mechanism, large-volume solution feeding systems up to 8L, multiple multi-emitter spinning heads (37 emitters each), environmental control, and automation tools to support reproducible manufacturing and pilot-scale development, all the process data-driven.
Fluidnatek BioFlat
Engineered electrospinning machine for the production of electrospun medical flat sheets, such as wound dressings, patches, flat scaffolds, etc.
The Fluidnatek LE-500 BioFlat electrospinning machine is designed for production of medical flat sheets, combining the process control needed for validated manufacturing (e.g. under GMP or ISO 13485) with the flexibility required for R&D and pilot-scale work.
This system incorporates Fluidnatek’s experience gained through multiple biomedical electrospinning projects relating wound healing patches, where reproducibility, process control, and product homogeneity, and consistency batch-to-batch, as well as system-to-system matching, are critical requirements. That experience is reflected in the platform design, which focuses on clean chamber operation and hygienic design, reproducible batch-to-batch performance thanks to a tight process control on many variables affecting the electrospinning process, and compatibility with controlled manufacturing workflows.
Maximum process control is reinforced by the Fluidnatek Environmental Control Unit (ECU), which provides precise temperature and humidity control inside the chamber and works together with the actively regulated exhaust system to maintain stable and safe operating conditions.
If required by the customer, Fluidnatek can support process development and validation activities such as DQ/IQ/OQ (Design Qualification | Installation Qualification | Operational Qualification), including also PQ (Performance Qualification) if needed, so the machine can be delivered with a specific process that has been optimized in line with the established product requirements and specifications for the electrospun material.
For medical flat sheets production, validation, documentation, and repeatability are essential. The Fluidnatek LE-500 BioFlat electrospinning systems is designed to support those requirements with a platform built for tightly controlled processing and scalable manufacturing.
The product sheet provides accurate and detailed information to help you meet your needs. Details make the difference, so choosing the right process to meet your needs will mean more comfort and the best user experience.
See all the features in our technical information sheet.
Some of the features of our Fluidnatek LE-500 BioFlat machine are:
- Especially designed for the development and production of electrospun medical sheets, such as: 2D scaffolds, wound dressings, patches and flat multi-layer structures.
- Software tools for GMP/ISO certification: audit trail & batch control.
- In-line thickness + area density metrology system in real time.
- Roll-to-Roll collector, and rotating drum collector also available.
- Multi-nozzle injectors with field deflectors (up to 370 nozzles).
- Environmental Control Unit: ECU.
| Feature | Fluidnatek LE-500 bioflat Specification | Why It Matters |
|---|---|---|
| Equipment Type | Pilot-line electrospinning platform specifically configured to produce medical flat sheets | Supports electrospun medical flat sheets with excellent performance and meeting medical requirements, for both production and pilot-scale development. |
| Footprint (Fluidnatek LE-500 Bioflat) | Machine: 1250 (W) × 1600 (D) × 2200 (H) mm Weight: ~ 800 kg (configuration dependent) | Verify floor load capacity (~800 kg) and adequate clearance for the ECU (Environmental Control Unit) if selected. |
| Voltage Range | Positive high-voltage power supply 0 to +30 kV or up to +50kV for emitter, and negative high-voltage power supply 0 to −30 kV for the collector. Bipolar high-voltage power supplies (−30 kV to +30 kV) can be alternatively integrated, for emitter and/or collector | Independent positive and negative voltage in emitter and collector improves process stability and fiber/particle deposition onto the collector. Particularly, the bipolar power supplies enable to switch the polarity of voltage between the emitter and collector, delivering a higher flexibility to process solutions with different polarity. |
| Actively regulated Exhaust System | Smart exhaust fan for solvent vapor extraction | 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), working in synchrony with the actively regulated exhaust system | Precise, stable environmental control is critical for reproducible fiber 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 pharmaceutical manufacturing conditions by providing an ultra-clean environment in the spinning chamber. |
| Y-Axis Scanning Emitter Motion | Linear automated motion of the spinning head, with adjustable both linear speed and stroke length (range: 0–500 mm) | Enables more homogeneous, uniform sheets all across the collector (normally roll-to-roll), thanks to achieving an even fiber deposition. |
| Batch Volume | From <1 mL up to 8 L of spinning solution (using two semi-continuous peristaltic feeding systems with 4 L reservoir each) | Covers the full range from small feasibility studies (preliminary proof-of-concept) to large industrial pre-series batches on a single electrospinning platform. |
| Collector Type | Roll-to-roll collector (500 mm wide) with conveyor belt mechanism (but also rotating collectors such as drums can be installed) | Enables semi-continuous fabrication of flat sheets of up to 500mm width. The conveyor belt mechanism prevents determined substrates from adhering at some points/locations, resulting in wrinkles or cracks. |
| Solution Feeding Systems | Peristaltic liquid feeding systems with gravimetric device, and/or high-pressure syringe pumps | The peristaltic liquid feeding systems with gravimetric device enable longer runs (up to 8L solution). To process highly-viscous solutions, the high-pressure syringe pumps can be the most suitable solution (up to 4 independent channels, 560mL overall solution volume). |
| Needle-based Spinning Heads | Up to 10 spinning injectors with common rail → max 370 emitters/needless | The Fluidnatek LE-500 BioFlat supports a high throughput for manufacturing, but with flexibility allowing to go from one single-needle for R&D work up to 370 emitters for maximum industrial throughput. |
| Needle-less Technology | Fluidnatek needle-less Slit Injector | Fluidnatek needle-less Slit Injectors are also available, so that any solution can be tested with both needle-based and needle-less technologies if wanted. |
| Advanced Software & Process Automation | Advanced tools for data collection, process automation, event management, batch control and remote monitoring and commanding, enabling comprehensive data integration and data-driven operations) | Demonstrating process consistency and repeatability is fundamental to high-level research. Fluidnatek High-Definition Process Data Hub facilitates this by monitoring over 40+ process parameters and equipment signals, presenting them through an intuitive, customizable dashboard for comprehensive data-driven control. To complement this, Fluidnatek Programmable Multi-Step Recipe function introduces advanced automation. This enables the equipment to execute complex processes autonomously from start to finish—including time-dependent parameter adjustments—thereby eliminating variability and errors associated with human intervention. Audit Trail: Internally logs all system events and user actions during operation, ensuring the full traceability required for GMP (Good Manufacturing Practice) compliance. Batch Control: 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. Tamper-proof batch management is essential for biomedical and pharmaceutical applications, providing a significant advantage in other research and industrial fields. Remote equipment monitoring & commanding software tools, in the direction of Industry 4.0. Machine Qualification: Full support for ISO 13485 or GMP validation, including comprehensive documentation and on-site services such as IQ/OQ (Installation Qualification and Operational Qualification), FAT/SAT, and PQ (Performance Qualification) to ensure the equipment meets specific process requirements. |
| Thickness metrology | In-line thickness metrology in real-time for rotating collectors | In-line real-time metrology enables thickness-triggered process automation when processing on rotating collectors (e.g. drums), ensuring every batch meets specification. It ensures uniformity (flat profile of the electrospun layer) and provides automated material compensation. Critical for validated pharmaceutical, medical device, and advanced filtration manufacturing. The Fluidnatek thickness metrology system takes the batch rejection nearly to zero. |
| Dual Spinning | Secondary spinning stage with separate high-voltage power supply | Dual spinning allows to simultaneously process two solutions, aiming the creation of composite or hybrid structures (e.g. two types of fibers, or fibers + particles) with independent control of voltage and flow rate for each material. |
| Cleanroom Compatibility | Minimum ISO 7, up to ISO 5 cleanliness level within the chamber (particle counting) | Cleanroom-ready configuration supports pharmaceutical, medical device, and advanced materials manufacturing. Advanced configuration for ultra-clean spinning in applications requiring clean environments. |
What is the Fluidnatek BioFlat LE-500 platform designed for?
The Fluidnatek LE-500 BioFlat is an electrospinner designed for production of electrospun medical flat sheets (nanofiber-based sheets) with a pilot-line configuration that supports R&D, pilot-scale development, and semi-continuous manufacture.
Does the Fluidnatek BioFlat LE-500 support cleanroom-oriented workflows?
Yes. This electrospinning platform was conceived with hygienic design, uses cleanable materials and can maintain ISO 7 or up to ISO 5 cleanliness grade within the spinning chamber..
What kind of environmental control does the Fluidnatek BioFlat LE-500 offer?
The platform can be equipped with an Fluidnatek Environmental Control Unit (ECU) enabling heating, cooling and drying, humidifying (all degrees of freedom), for precise temperature and humidity control, working together with the actively regulated exhaust system. The Fluidnatek ECU has been developed for a particular evaporative process as electrospinning, to perform optimally with the Fluidnatek electrospinning platforms. .
Can the Fluidnatek BioFlat LE-500 support batch-to-batch consistency?
Yes. The platform includes automation features such as programmable multi-step recipe function (to remove human error), advanced data collection, precise environmental control, and in-line thickness metrology system, and other features oriented towards tight process control, in order to ensure consistency batch-to-batch, repeatability, and system-to-system matching in equipment fleets.
Does the Fluidnatek BioFlat LE-500 support roll-to-roll processing?
Yes. The Fluidnatek LE-500 BioFlat supports roll-to-roll collector for semi-continuous fabrication of flat sheets. Importantly, the roll-to-roll is complemented with a conveyor belt mechanism, to run smoothly different types of substrates and carriers.
Can Fluidnatek render validation services for the Fluidnatek LE-500 BioFlat electrospinning platform?
Yes. Fluidnatek can support IQ/OQ service (Installation Qualification | Operational Qualification) and documentation package, on-site service, and full process development and validation, including PQ or Performance Qualification when required by the customer.
Semi-Continuous Processing: From Individual A4 Sheets to Pre-Industrial Batches
The Fluidnatek LE-500 BioFlat electrospinning equipment is designed to meet electrospun flat sheet production (nanofiber-based films), subject to demanding biomedical requirements, intended to deliver materials at every scale —from individual A4 sheets (handsheets) to hundreds of square meters per batch in material rolls. Multi-emitter spinning heads with field deflectors and balanced solution flow deliver excellent deposition uniformity and high throughput.
The platform features a roll-to-roll collector system with a maximum substrate width of 500 mm for semi-continuous flat sheet production, complemented with a conveyor belt mechanism. With support for up to 370 emitters and large-volume gravimetric feeding systems processing up to 8 liters of solution per batch, the Fluidnatek LE-500 BioFlat is the appropriate platform for fabricating pre-industrial volumes (or industrial volumes, depending on the material volumes required) of medical-grade nanofiber flat sheets.
Applicatons
The Fluidnatek LE-500 BioFlat is designed to support the development and pilot-scale production of advanced electrospun flat-sheet materials for biomedical and healthcare applications. Thanks to its high level of process control, environmental regulation, and medical-manufacturing-oriented features, the platform is particularly suitable for applications where reproducibility, uniformity, and product consistency are critical requirements.
Typical applications include:
- Advanced wound dressings – Electrospun structures designed to support moisture and gas-exchange management, drug loading, and tissue regeneration strategies.
- Tissue engineering scaffolds – Nanofibrous substrates for regenerative medicine applications requiring controlled architecture (whether randomly deposited or aligned fibers) and reproducible manufacturing conditions.
- Drug delivery systems – Electrospun matrices and coatings for the controlled release of active pharmaceutical ingredients.
- Barrier and protective membranes – Functional nanofiber layers engineered to provide selective permeability, fluid management, or protective functions.
- Biomedical filtration and separation media – High-surface-area nanofiber materials for healthcare and life science filtration and separation
- Research and development of novel electrospun medical products – Process development, optimization, and scale-up of innovative biomedical materials from preliminary laboratory validation to pilot manufacturing.
The Fluidnatek LE-500 BioFlat provides the process control and scalability required to transition these applications from early-stage development to reproducible pilot-scale production.
Clean Chamber Design for Medical Device Manufacturing
Since initiating our experience with ISO 13485 and GMP (Pharma)-certified processes and cleanroom manufacturing facilities in 2017, Fluidnatek has applied the same engineering principles to the Fluidnatek LE-500 BioFlat electrospinning platform. The result is a spinning chamber with a hygienic design, that maintains ISO 7 cleanliness grade (or up to ISO 5), equipment compatible with cleanroom installation, and is constructed from robust, solvent-cleanable materials throughout.
The platform uses cleanable materials, helping support operation in controlled environments where cleanliness and repeatability matter. Also system-to-system matching is key when managing fleets with multiple pieces of equipment manufacturing the same electrospun material. This design logic is aligned with the demands of medical flat sheets production.
HEPA Filtration and Solvent-Cleanable Materials
HEPA filtration is implemented in the Fluidnatek LE-500 BioFlat machine to maintain the required air cleanliness within the spinning chamber (inlet air and/or exhaust). Robust, solvent-cleanable materials are used throughout the chamber construction, supporting thorough cleaning between production batches and the hygienic conditions required for ISO and GMP-compliant medical device manufacturing.
Precise Solution Dosage for Medical-Grade Nanofiber Production
Control and precision in solution delivery are critical in medical and pharmaceutical device manufacturing. The Fluidnatek LE-500 BioFlat solution feeding systems are engineered to meet demanding requirements for solution dispensing at every production scale, whether at small-scale with high-pressure syringe pumps of great performance, or at large-scale with gravimetrically controlled large-volume systems (up to 4L each).
Gravimetric Large-Volume Feeding
The Fluidnatek LE-500 BioFlat uses a gravimetrically controlled peristaltic liquid feeding system with a 4-liter solution reservoir. High-pressure syringe pumps are also available. With dual peristaltic solution feeding systems, the equipment supports batches of up to 8 liters of spinning solution, enabling extended semi-continuous flat sheet production runs.
Dual-Material Deposition
A second solution feeding system can be integrated, enabling simultaneous deposition of two different materials within the same electrospun flat sheet — for example, combining bioactivity and mechanical strength in a single membrane or wound dressing structure.
Automated Batch-to-Batch Consistency
Product consistency is one of the most important requirements in medical and pharmaceutical device manufacturing. The Fluidnatek LE-500 BioFlat equipment includes process automation features designed to reduce operator error and improve batch repeatability, including programmable multi-step recipes in-line thickness metrology.
In-Line Metrology for Deposition Thickness and Area Density
The platform may integrate in-line metrology systems capable of measuring deposition thickness and/or area density (gsm) during production. These systems can be configured to automatically stop the process once the target deposition value is reached, helping reduce end-point variability and improve batch-to-batch consistency.
The Fluidnatek LE-500 BioFlat supports in-line thickness measurement in rotating collectors, as well as in-line area density measurement. By providing real-time process feedback, these tools support tighter process control, reduced material waste, and more reproducible manufacturing outcomes.
Climate-Controlled Electrospinning: Environmental Control Unit (ECU)
Stable temperature and humidity within the spinning chamber are also prerequisites for a reproducible electrospinning process and consistent medical flat sheet quality. As one of the first companies to develop climate control systems designed specifically for electrospinning process in our electrospinning equipment, Fluidnatek has built extensive expertise in this area.
The Fluidnatek Environmental Control Unit (ECU) is capable of heating, cooling, drying, and humidifying the spinning environment. It communicates directly with the actively regulated exhaust system to maintain the optimum balance between process stability and operator safety — ensuring the spinning environment remains stable throughout every production run.
GMP-Compliant Electrospinning: Validation and Qualification Support
Manufacture of medical flat sheets requires validated processes and properly documented manufacturing runs. The Fluidnatek LE-500 BioFlat is equipped to support these requirements with multi-user level access control, batch control and audit trail functions, and high-definition process data collection for extensive track record of process variables and equipment signals.
Fluidnatek provides an IQ/OQ (Installation Qualification | Operational Qualification) documentation package and on-site qualification service. A full process development and Performance Qualification (PQ) service is also available to support process validation for defined product specifications.
Seamless Scale-Up from Lab to Pilot Manufacturing
The Fluidnatek LE-500 BioFlat supports the transition from initial concept to pilot-scale manufacture. It delivers semi-continuous production of high-quality medical flat nanofiber sheets, maintaining consistent fiber morphology and uniformity all across the medical flat sheet.
If you are developing advanced electrospun medical products, the Fluidnatek LE-500 BioFlat provides the process control, scalability, and reproducibility needed to move from development to pilot manufacturing.
Talk to a Fluidnatek specialist about your product specifications, throughput requirements, and manufacturing objectives.
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