Eurotech K2A Multi-Layer Co-Extrusion Blown Film Line for Medical-Grade Films
| Brand | Eurotech |
|---|---|
| Origin | Italy |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | K2A |
| Price Range | USD 68,000 – 136,000 |
Overview
The Eurotech K2A Multi-Layer Co-Extrusion Blown Film Line is an engineered solution designed specifically for the production of high-integrity, medical-grade polymeric films requiring strict regulatory compliance and batch-to-batch consistency. Built upon Eurotech’s XTR extrusion platform, this line employs a co-rotating twin-screw extrusion architecture optimized for precise melt homogenization, thermal stability, and low shear degradation—critical parameters when processing sensitive polymers such as ethylene vinyl alcohol (EVOH), polyethylene terephthalate glycol-modified (PETG), cyclic olefin copolymers (COC), and medical-grade polyethylene (PE) and polypropylene (PP). The system operates on the fundamental principle of simultaneous extrusion of multiple polymer melts through a concentric annular die, followed by controlled bubble inflation, cooling via double-lip air ring systems, and precision layflat stabilization. Its modular design supports both monolayer and up to 5-layer co-extrusion configurations, enabling functional barrier structures essential for sterile packaging, IV bags, pharmaceutical blister lidding, and implantable device pouches.
Key Features
- Modular XTR extruder platform with screw diameters ranging from 20 mm to 35 mm, each equipped with application-specific screw profiles (e.g., conveying, melting, mixing, and degassing zones) tailored for medical polymer rheology.
- Integrated rear-screw extraction system enabling tool-free, sub-5-minute screw removal and replacement—minimizing downtime during grade changeovers or preventive maintenance.
- Configurable mechanical layout: compact single-platform mounting for space-constrained cleanrooms or independent height-adjustable support frames accommodating integration with downstream sterilization tunnels, inline thickness gauging (beta or IR), and ISO Class 7/8 environmental enclosures.
- Dual-mode screen changer: manual lever-actuated unit mounted directly in the extruder flange for rapid intervention, or dual-position hydraulic screen changer supporting uninterrupted operation during mesh replacement—critical for GMP-compliant continuous manufacturing.
- Stainless steel construction (AISI 316L contact surfaces), electropolished internal channels, and validated cleanability per ISO 14644-1 and EU GMP Annex 1 requirements for medical device packaging lines.
- PLC-based control system with redundant temperature zoning (±0.5 °C accuracy), pressure monitoring at all die ports, and real-time torque feedback per extruder—ensuring process traceability and repeatability across validation protocols.
Sample Compatibility & Compliance
The K2A line is validated for processing USP Class VI–compliant resins, including but not limited to LDPE, LLDPE, mLLDPE, EVA, and ethylene-acrylic acid (EAA) tie layers. It supports film thickness ranges from 25 µm to 250 µm with radial thickness uniformity ≤±3.5% (measured per ASTM D374 and ISO 4593). All wetted components conform to FDA 21 CFR §177.1520 and §177.1210 for indirect food and medical device contact. The system architecture facilitates IQ/OQ/PQ documentation packages aligned with ISO 13485:2016 and EN ISO 14001:2015 environmental management frameworks.
Software & Data Management
The integrated HMI runs on a Windows-based SCADA platform compliant with FDA 21 CFR Part 11, supporting electronic signatures, audit trails, and role-based user access control. Process data—including melt temperature profiles, motor amperage, die pressure differentials, and bubble diameter—are logged at 100 ms intervals and exportable in CSV or .tdms formats for statistical process control (SPC) analysis. Optional MES connectivity enables direct integration with SAP S/4HANA or Siemens Opcenter Execution for batch record synchronization and electronic batch release workflows.
Applications
- Sterile barrier packaging for Class II and III medical devices (e.g., orthopedic implants, catheter kits).
- Flexible pouches for terminally sterilized pharmaceuticals (gamma/E-beam compatible).
- Laminated films for diagnostic test strips and biosensor substrates.
- Multi-layer tubing preforms used in extrusion blow molding of drug delivery containers.
- Custom barrier films incorporating antimicrobial masterbatches meeting ISO 22196 standards.
FAQ
Is the K2A line suitable for cleanroom installation?
Yes—the structural frame, extruder housings, and die head assemblies are fabricated from electropolished AISI 316L stainless steel and designed for ISO Class 7 (10,000) cleanroom compatibility, including provisions for HEPA-filtered air purge manifolds.
Can the system be validated under GMP guidelines?
Yes—Eurotech provides full FAT/SAT documentation, IQ/OQ templates aligned with ASTM E2500, and optional third-party validation support for FDA or MDR submissions.
What level of technical support is available post-installation?
Eurotech offers remote diagnostics, annual preventive maintenance contracts, and on-site operator training certified to VDA 6.3 process audit criteria.
Does the line support nitrogen purging for oxygen-sensitive polymers?
Yes—integrated inert gas manifolds are available at extruder feed throats, melt pumps, and die adapters to maintain O₂ levels below 50 ppm during processing of EVOH or PVDC layers.
