Extrusion lines for medical products

Complete systems compliant with international standards

Extrusion lines for medical tubing, bags and film sheets

Bausano is internationally recognized as a reference manufacturer of complete medical extrusion lines, designed to ensure geometric precision, repeatable results and compliance with international regulatory standards, including European Pharmacopoeia, ISO 10993 and USP Class VI. The systems are developed for the production of flexible tubing and bags used in infusion, ventilation, dialysis, drainage and fluid management devices for healthcare applications. The lines are compatible with the extrusion of materials certified for medical use, including medical-grade PVC, TPU, TPE, PE, PP, EVA and fluoropolymers, selected for their biocompatibility, sterilizability and dimensional stability. Every solution is designed to ensure a high level of plant asepsis, preventing contamination along the material path and guaranteeing complete traceability of batches and process parameters.

Consistent performance, full control and certified compliance

Bausano medical extrusion lines are available in E-GO single-screw and MD parallel twin-screw configurations, selected according to the material characteristics and required production profile. Each system is equipped with extrusion heads designed to ensure uniform flow and geometric control of the tube, stainless steel tanks for calibration and cooling, high-precision pneumatic haul-offs, CNC cutters up to 3,000 cuts per minute and automatic winders with continuous reel change. Laser and ultrasound measuring systems enable real-time monitoring of diameter, ovality and wall thickness across the entire line. Extrusion speeds can reach up to 120 metres per minute, while maintaining tight tolerances and dimensional stability, even with multilayer materials or radiopaque filled compounds. All systems can integrate IoT technologies for remote monitoring and automatic adjustment of process parameters. Thanks to its vertically integrated project management, Bausano acts as a single partner for complete, reliable solutions compliant with the requirements of the medical sector.

Applications and requirements for the healthcare sector

Bausano extrusion lines for the medical sector are designed to produce flexible tubing, bags and technical sheets for infusion, drainage, dialysis, ventilation, enteral nutrition and sterile packaging devices. These applications require systems able to ensure not only high dimensional precision, but also absolute repeatability of process parameters, which is essential to guarantee consistent quality in the finished product. In the healthcare sector, it is essential to comply with the main international standards, including European Pharmacopoeia, ISO 10993 and USP Class VI, which regulate biocompatibility, traceability, sterilizability and the absence of contaminants. Medical tubing, bags and sheets must have smooth and uniform surfaces, regular sections, no inclusions and strict control of wall thickness, concentricity and optical transparency, depending on the application. The materials used, medical-grade PVC, TPU, EVA, TPE, PE, PP and fluoropolymers, must also maintain their chemical and physical properties after sterilization, transport and storage. The goal is to ensure patient safety, device functionality and compliance with validation procedures, in line with the requirements of quality systems in the medical sector.

Medical tubing

Medical tubing is a flexible conduit used for the safe transfer of fluids and gases in clinical applications such as infusion, ventilation, drainage and dialysis. Made from medical-grade materials such as PVC, TPU or polyolefins, these tubes must ensure transparency, flexibility, chemical resistance and compatibility with the main sterilization processes. They are available in different configurations, including single-layer, multilayer or radiopaque solutions, with very tight dimensional tolerances and compliance with sector standards.

Medical bag

A medical bag is a flexible container designed for the storage, administration or transport of sterile solutions, biological fluids and drugs in healthcare applications. These bags are available in different sizes and volumes, using materials that meet Pharmacopoeia requirements and medical regulations for contact with liquids intended for patients. The multilayer structure can provide functional barriers, reliable sealability and mechanical resistance, ensuring consistent performance after sterilization and during clinical use.

Medical sheet

A medical sheet is a technical plastic film suitable for producing primary and secondary packaging components for medical and pharmaceutical devices. The finished product stands out for flatness, controlled thickness, optical transparency and protection against external agents: essential features to preserve content integrity until final use. Medical sheets are used in applications such as blisters, sterile pouches and barrier membranes, where surface quality and compliance with production parameters are critical requirements.

Medical lines with single screw extruder: direct processing from certified pellets

In the medical sector, Bausano E-GO series single screw extrusion lines are the ideal solution when the production process starts from pre compounded pellets certified for healthcare use. In this scenario, the raw material has already passed biocompatibility and sterilizability tests according to standards such as USP Class VI and ISO 10993, simplifying the following stages. The E-GO extruder ensures melt stability, accurate thermal control and continuous processing up to 120 metres per minute, with consistent performance even on high intensity batches. Bausano lines are designed to ensure energy efficiency, waste reduction and integration with digital measurement and control systems. Each system can be configured according to production requirements and can also be purchased through operating lease solutions. The overall value of the line ranges from 100,000 to 300,000 euros, depending on layout, processed materials and automation level. Bausano’s approach, focused on customization and reliability, is a solid choice for manufacturers oriented towards quality and regulatory compliance.

Twin screw extrusion lines for the medical sector: direct processing from powder with certified compliance

For the production of PVC medical tubing from powder raw material, Bausano MD series parallel twin screw extrusion lines offer maximum control over the transformation process. The system accurately manages every stage, from dosing and plasticization to degassing and tube forming, ensuring material homogeneity, no degradation points and compliance with the strictest dimensional tolerances. The final product is fully compliant with biocompatibility and traceability standards, ready for use in regulated healthcare applications. This configuration gives manufacturers greater autonomy over raw material management, helping optimize costs and reduce dependence on external supplies. MD extruder lines are developed to ensure low processing temperatures, improving PVC thermal stability and extending system service life. The overall cost of the line can range from 200,000 to 500,000 euros, depending on the level of customization and the selected downstream accessories. Bausano also supports customers with tailor made financial solutions, acting as a reliable partner for the certified production of high performance medical tubing.

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Regulatory compliance

Regulatory compliance in the medical sector requires not only adherence to technical standards, but also the ability to document every stage of the process. Bausano supports customers in preparing the documentation required for plant validation, providing complete component traceability, technical manuals, testing protocols and support for IQ/OQ documentation. The lines can be configured to operate in environments regulated by GMP, ISO 13485 or FDA, supporting integration with the customer’s quality systems. This approach reduces audit times and accelerates device production start up, ensuring real regulatory compliance, not just declared compliance

Certified quality

For Bausano, quality is not an abstract concept, but an engineering approach that involves the entire supply chain: from material selection to mechanical design, through to functional testing of the line. Each system is built with certified components and assembled according to rigorous procedures, ensuring structural strength, wear resistance and long term operational continuity. This attention results in reliable, durable systems that exceed industrial standards. It is a quality model that goes beyond tube production: it is a performance guarantee, designed for highly critical applications such as medical extrusion.

Minimum tolerances

In the medical sector, tube dimensional control is essential. Even minimal deviations in outer diameter, wall thickness or concentricity can compromise device functionality or compatibility with standardized connection systems. Bausano lines are designed to maintain tight and constant tolerances, even at high extrusion speeds and on small diameter geometries. Integrated laser or ultrasound measurement systems monitor critical parameters in real time, ensuring process stability and reducing the risk of non conformity. This precision makes it possible to obtain a perfectly repeatable medical tube, compliant with healthcare standards and ready for validation in regulated environments.

Technical consulting for advanced medical lines

Do you need technical consulting to design an extrusion line dedicated to the production of medical tubing and components, optimized for energy efficiency, process precision and hourly productivity? The Bausano team is available to analyze the specific requirements of medical applications and configure a tailor made solution, compliant with the quality standards and production goals of your plant.

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A starting point to define the right solution together

By filling in the form below, it is possible to describe specific technical or production requirements. The technical team will carefully evaluate the request in order to propose the most suitable extrusion line or extruder.