{"product_id":"rt-medline","title":"RT MedLine – Cleanroom Electrospinning System for Medical Device Manufacturing","description":"\u003ch3\u003eRT MedLine is a cleanroom electrospinning system for medical device manufacturing: washable stainless steel structures, automatic mandrels and an anthropomorphic robotic arm, climate control precise to 10–70% RH ±2% and ambient–50 °C ±1 °C, built around a 21 CFR Part 11 audit trail and closed-loop thickness control.\u003c\/h3\u003e\n\n\u003cp\u003eIt is not a laboratory instrument adapted for production. It is a \u003cstrong\u003eproduction island\u003c\/strong\u003e designed for companies that manufacture scaffolds, vascular grafts and other electrospun implantable devices, and that have to prove how every unit was made.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eRT MedLine is in production today\u003c\/strong\u003e, manufacturing grafts at a medical device company. Under a confidentiality agreement we cannot name the customer, but the platform is not a concept: it is running.\u003c\/p\u003e\n\n\u003ch2\u003eA clean island, not a machine in a room\u003c\/h2\u003e\n\n\u003cp\u003eThe external structures are \u003cstrong\u003estainless steel, designed to be washed\u003c\/strong\u003e — no painted surfaces, no crevices that survive a cleaning validation. Inside the chamber, \u003cstrong\u003eautomatic mandrels\u003c\/strong\u003e handle the tubular substrates. Outside, an \u003cstrong\u003eanthropomorphic robotic arm\u003c\/strong\u003e loads and unloads them.\u003c\/p\u003e\n\n\u003cp\u003eThe result is a closed production cell: parts go in, finished scaffolds or grafts come out, and the operator does not reach inside between cycles. Fewer human interventions mean fewer contamination events and fewer deviations to justify to an auditor.\u003c\/p\u003e\n\n\u003ch2\u003eTwo independent groups, so one device can be two materials\u003c\/h2\u003e\n\n\u003cp\u003eRT MedLine inherits the architecture of \u003ca href=\"https:\/\/www.linarinanotech.com\/products\/rt-advanced\"\u003eRT Advanced\u003c\/a\u003e: \u003cstrong\u003etwo fully independent spinning groups\u003c\/strong\u003e, each with its own \u003cstrong\u003e60 kV generator\u003c\/strong\u003e, its own \u003cstrong\u003efour pumps\u003c\/strong\u003e, its own \u003cstrong\u003eautomatic needle cleaning\u003c\/strong\u003e and its own \u003cstrong\u003eblow spinning system\u003c\/strong\u003e, placed symmetrically about the collector axis — with the mandrel itself acting as an electrostatic shield between them.\u003c\/p\u003e\n\n\u003cp\u003eFor an implantable device that matters more than it does in a laboratory. A vascular graft is rarely one material: an inner layer that faces blood and an outer layer that provides mechanical strength are different polymers with different processing windows. With two independent groups, they are deposited on the same mandrel \u003cstrong\u003ein a single run\u003c\/strong\u003e, at different voltages and different gas flows, without opening the cell to reconfigure it between layers.\u003c\/p\u003e\n\n\u003cp\u003eEvery layer transition that does not require opening the chamber is one less contamination risk and one less step to describe in a batch record.\u003c\/p\u003e\n\n\u003ch2\u003eAutomation that moves the samples and the data\u003c\/h2\u003e\n\n\u003cp\u003eInside the cell, the \u003cstrong\u003erobotic arm\u003c\/strong\u003e handles loading and unloading. Between cells, \u003cstrong\u003eautonomous guided vehicles (AGVs)\u003c\/strong\u003e move samples to the next step of the process — drying, characterisation, packaging — without an operator carrying trays across a controlled area. Each transfer is one less opportunity for contamination and one less manual step to describe in a procedure.\u003c\/p\u003e\n\n\u003cp\u003ePhysical automation on its own, though, only moves the paperwork somewhere else. What makes the cell useful is that the material and its record travel together: each sample is identified, the machine writes the run record against that identity, and the data flows into your systems as it is produced. Voltage, flow rates, gas flow, temperature, humidity, mandrel speed and measured thickness are logged for every unit and reconciled with the device that came out of the chamber.\u003c\/p\u003e\n\n\u003cp\u003eThe result is a \u003cstrong\u003edigital thread\u003c\/strong\u003e from raw solution to finished device: when an auditor asks how a specific graft was made, the answer is a query, not an archive search. And because the integration is built on \u003cstrong\u003eAlleantia\u003c\/strong\u003e technology, the cell speaks the protocols your MES and quality system already use rather than requiring a bridge built for the occasion.\u003c\/p\u003e\n\n\u003ch2\u003eBuilt around your process, not around our catalogue\u003c\/h2\u003e\n\n\u003cp\u003eGeometries are \u003cstrong\u003ecustomised to the application\u003c\/strong\u003e: chamber dimensions, mandrel sizes and count, robot reach, AGV routing and the layout of the cell are defined with you, because a coronary graft, a nerve conduit and a hernia patch do not need the same island.\u003c\/p\u003e\n\n\u003cp\u003eThis is a configured system, specified before it is built. It starts from a conversation about the device you make, not from a datasheet.\u003c\/p\u003e\n\n\u003ch2\u003eEvery unit, documented\u003c\/h2\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eNamed user accounts with role-based access.\u003c\/strong\u003e Every action is attributed to a person, not to a shared login.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA complete audit trail, designed to meet 21 CFR Part 11\u003c\/strong\u003e — parameter changes, run start and stop, alarms and interventions recorded with user, timestamp and electronic signature.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAlarms sent by email\u003c\/strong\u003e as they occur, so an out-of-range parameter or a fault does not go unnoticed between visits.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFull process telemetry\u003c\/strong\u003e for every run: voltage, flow rates, gas flow, temperature, humidity, mandrel speed and measured thickness.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eQualification documentation\u003c\/strong\u003e for regulated environments, available on request.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2\u003eThickness is a release parameter, so the machine controls it\u003c\/h2\u003e\n\n\u003cp\u003eOne or more laser sensors measure the deposit on the rotating mandrel in several positions during the run, with an accuracy of 10 nanometers. Deposition continues until the \u003cstrong\u003etarget thickness\u003c\/strong\u003e is reached, then stops on its own.\u003c\/p\u003e\n\n\u003cp\u003eMeasuring in more than one position also tells you whether the wall is \u003cem\u003euniform\u003c\/em\u003e along the graft, not only how thick it is at one point. For an implantable device, that is the difference between a measurement and a specification.\u003c\/p\u003e\n\n\u003ch2\u003eYour batch records, in your systems\u003c\/h2\u003e\n\n\u003cp\u003eRT MedLine complies with the \u003cstrong\u003eEU Data Act\u003c\/strong\u003e: free, secure, programmatic access to configuration and telemetry data, built on \u003cstrong\u003eAlleantia\u003c\/strong\u003e technology with more than ten integration protocols. Batch records can be written straight into your MES, your validated cloud platform or your internal servers — where your quality system already lives.\u003c\/p\u003e\n\n\u003ch2\u003eClean process, clean fibres\u003c\/h2\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eNo internal tubing.\u003c\/strong\u003e The syringes move with the needles, so nothing is left in a tube between runs, there is no dead volume at material change, and cross-contamination is structurally prevented rather than managed by cleaning.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eElectrically insulating chamber surfaces.\u003c\/strong\u003e Competing systems use earthed metal structures, and earthed metal near a high voltage field attracts nanofibres continuously — material that never reaches the mandrel.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAutomatic needle cleaning\u003c\/strong\u003e with timed jets of compressed gas on each group, the most common cause of an interrupted run removed.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eClimate control with solvent extraction.\u003c\/strong\u003e The external air treatment unit holds 10–70% RH to within 2% and ambient to 50 °C to within 1 °C \u003cem\u003ewhile\u003c\/em\u003e extracting solvent vapour, with an airflow gentle enough not to strip fibres off the mandrel.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eInert gas flushing\u003c\/strong\u003e for oxygen-sensitive materials.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2\u003eSupport for a validated process\u003c\/h2\u003e\n\n\u003cul\u003e\n\u003cli\u003eWarranty extensions up to five years.\u003c\/li\u003e\n\u003cli\u003eScheduled maintenance plans designed to support your regulatory obligations, not only to fix faults.\u003c\/li\u003e\n\u003cli\u003eDedicated remote assistance module.\u003c\/li\u003e\n\u003cli\u003eDirect access to our R\u0026amp;D team in Pisa — the people who built the machine.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003e\u003cstrong\u003eOne electrospinning ecosystem, from first experiment to validated production.\u003c\/strong\u003e RT MedLine is the cleanroom configuration of the same platform that starts on \u003ca href=\"https:\/\/www.linarinanotech.com\/products\/all-in-one\"\u003eAll In One\u003c\/a\u003e and scales through \u003ca href=\"https:\/\/www.linarinanotech.com\/products\/rt-advanced\"\u003eRT Advanced\u003c\/a\u003e — backed by \u003cstrong\u003e400+ installations\u003c\/strong\u003e, \u003cstrong\u003e124 peer-reviewed publications\u003c\/strong\u003e and customers in \u003cstrong\u003e70+ countries\u003c\/strong\u003e.\u003c\/p\u003e\n\n\u003ch2\u003eIs RT MedLine the right system?\u003c\/h2\u003e\n\n\u003ctable style=\"width: 100%;\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 30%;\"\u003e\n\u003cstrong\u003eRT MedLine\u003c\/strong\u003e\u003cbr\u003eCleanroom manufacturing\u003c\/td\u003e\n\u003ctd style=\"width: 70%;\"\u003eYou manufacture implantable or regulated devices, you need an automated clean cell and documented batch records. Geometry configured to your device.\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cstrong\u003e\u003ca href=\"https:\/\/www.linarinanotech.com\/products\/rt-advanced\"\u003eRT Advanced\u003c\/a\u003e\u003c\/strong\u003e\u003cbr\u003eMulti-material \u0026amp; unmanned\u003c\/td\u003e\n\u003ctd\u003eThe same two-group architecture and compliance stack, in a standard laboratory or production room: 2 × 60 kV, 8 pumps, up to 8 different materials in one deposit.\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cstrong\u003e\u003ca href=\"https:\/\/www.linarinanotech.com\/products\/pure-spinner\"\u003ePure Spinner\u003c\/a\u003e\u003c\/strong\u003e\u003cbr\u003eBulk substrate-free fibre\u003c\/td\u003e\n\u003ctd\u003eWhen the nanofiber itself is the product rather than a device: horizontal drum up to Ø250×600 mm, 0.47 m² of collecting area, up to 140 needles.\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\n\u003cp\u003eNot sure? \u003ca href=\"https:\/\/www.linarinanotech.com\/pages\/contact-r-d-expert\"\u003eTalk to an R\u0026amp;D expert\u003c\/a\u003e and we will define the cell around your device and your regulatory pathway.\u003c\/p\u003e\n\n\u003ch2\u003eFrequently asked questions\u003c\/h2\u003e\n\n\u003cdetails\u003e\n\u003csummary\u003e\u003cstrong\u003eIs RT MedLine already in use?\u003c\/strong\u003e\u003c\/summary\u003e\n\u003cp\u003eYes. A system is in production at a medical device manufacturer, producing grafts. Under a confidentiality agreement we cannot name the customer, but we can discuss the configuration and what it took to qualify it.\u003c\/p\u003e\n\u003c\/details\u003e\n\n\u003cdetails\u003e\n\u003csummary\u003e\u003cstrong\u003eCan it deposit two different materials on the same graft?\u003c\/strong\u003e\u003c\/summary\u003e\n\u003cp\u003eYes, in a single run. The two spinning groups are fully independent — own generator, own four pumps, own needle cleaning, own blow spinning system — and sit symmetrically about the mandrel, which acts as an electrostatic shield between them. An inner layer and an outer layer of different polymers can therefore be deposited at different voltages and gas flows without opening the cell between layers.\u003c\/p\u003e\n\u003c\/details\u003e\n\n\u003cdetails\u003e\n\u003csummary\u003e\u003cstrong\u003eDoes the machine make my process GMP compliant?\u003c\/strong\u003e\u003c\/summary\u003e\n\u003cp\u003eNo machine can do that: compliance belongs to your process and your quality system. What RT MedLine provides is the technical foundation an auditor expects — role-based user management, a 21 CFR Part 11 audit trail with electronic signature, complete process telemetry, washable stainless steel structures and qualification documentation on request.\u003c\/p\u003e\n\u003c\/details\u003e\n\n\u003cdetails\u003e\n\u003csummary\u003e\u003cstrong\u003eHow far can the cell be automated?\u003c\/strong\u003e\u003c\/summary\u003e\n\u003cp\u003eFrom loading to logistics. An anthropomorphic robotic arm loads and unloads the mandrels, and autonomous guided vehicles (AGVs) can move samples between the electrospinning cell and the next step of your process. Each sample keeps its identity through the chain, so the run record follows the material rather than being reconciled afterwards.\u003c\/p\u003e\n\u003c\/details\u003e\n\n\u003cdetails\u003e\n\u003csummary\u003e\u003cstrong\u003eCan the geometry be customised?\u003c\/strong\u003e\u003c\/summary\u003e\n\u003cp\u003eYes, and it normally is. Chamber dimensions, mandrel sizes and count, robot reach, AGV routing and cell layout are defined with you, because a coronary graft, a nerve conduit and a hernia patch do not need the same island.\u003c\/p\u003e\n\u003c\/details\u003e\n\n\u003cdetails\u003e\n\u003csummary\u003e\u003cstrong\u003eWhat can it produce?\u003c\/strong\u003e\u003c\/summary\u003e\n\u003cp\u003eTubular structures such as vascular grafts, nerve conduits and stent coatings on automatic mandrels, and flat scaffolds and patches. Any synthetic, organic polymer or ceramic material that can be electrospun from solution, plus melt electrospinning with heated needle systems and blow spinning with or without high voltage.\u003c\/p\u003e\n\u003c\/details\u003e\n\n\u003cdetails\u003e\n\u003csummary\u003e\u003cstrong\u003eHow is thickness controlled on a graft?\u003c\/strong\u003e\u003c\/summary\u003e\n\u003cp\u003eOne or more laser sensors measure the deposit on the rotating mandrel in several positions during the run, with an accuracy of 10 nanometers. Deposition stops automatically when the target is reached, and multi-point measurement shows whether the wall is uniform along the length of the graft.\u003c\/p\u003e\n\u003c\/details\u003e\n\n\u003cdetails\u003e\n\u003csummary\u003e\u003cstrong\u003eCan we integrate it with our MES or quality system?\u003c\/strong\u003e\u003c\/summary\u003e\n\u003cp\u003eYes, and free of charge. RT MedLine complies with the EU Data Act: configuration and telemetry data are available through secure programmatic access, built on Alleantia technology with more than ten integration protocols.\u003c\/p\u003e\n\u003c\/details\u003e\n","brand":"Linari Nanotech","offers":[{"title":"Default Title","offer_id":54775968727363,"sku":null,"price":0.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0255\/7109\/8704\/files\/Frontesfondotrasp2slide_e5a4aa7e-0dac-4170-a6c6-7da77c450a46.png?v=1788431950","url":"https:\/\/www.linarinanotech.com\/products\/rt-medline","provider":"Linari Nanotech","version":"1.0","type":"link"}