Medicinal product lines

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Description

Medical tubing is generally composed of 3 layers: a base polymer on the outside, an adhesive layer in the middle and an inner layer. Medical tubes are extruded and are medical devices. Therefore, the quality of the materials must be medical grade.

The medical extrusion lines produced by Bausano for tubes, pouches and foils are very high precision equipment.

The medical industry requires safe, reliable and custom-designed tools for processing PVC and other non-toxic health care materials permitted by industry regulations. Thanks to the technology of single and double-shank extrusion, as well as the wide range of accessories, Bausano offers various solutions, all customizable, for the construction of plants characterized by maximum production and efficiency.

In making these products, not only the material is important, but also the high-precision machining of extruded medical devices, especially for multi-lumen, microbore, coextruded or cross-extruded tubes, where diameter tolerances can be as low as ±5 µm. Catheter tubes also receive a lot of attention in the extrusion market, with tight tolerances on tube size.

To ensure that medical tubing maintains precise flow levels, the extrusion process must ensure consistency in all dimensions of the tubing. A typical tolerance for the medical tubing range is ±1%, which means that for a medical tube with an internal diameter of 1.6 mm, the accuracy is ±10 µm.

The outside diameter is controlled by vacuum calibration. Most Bausano extruders are equipped with precise low-level vacuum control, which keeps the outer diameter of the tube stable.

Internal lumens should also be checked carefully. In multi-lumen tubes, each lumen has a defined end use; the cross-sectional area controls the flow rate, the minimum internal diameter required for guide wire insertion and the characteristics for postforming operations.

Thanks to Bausano extrusion technology and related extrusion accessories, tubes can be produced with internal diameters ranging from 0.8 mm to 17 mm. All tubular products are manufactured to customer specifications in terms of material properties, measurements and tolerance requirements.

Bausano also produces medical extrusions for extruded medical bags made of various plastics such as PVC and PP. Bausano medical bags are medical grade plastic bags ranging from 80 mm to 420 mm wide and 0.1 mm to 0.65 mm thick. Despite polypropylene's excellent moisture barrier properties and high purity level, packaging designs for intravenous solutions rely heavily on polyvinyl chloride (PVC), glass and plasticised polyethylene. The finished product must be temperature, impact and corrosion resistant to withstand the high wear and tear and repeated sterilisation cycles that plastic medical devices are subjected to. For example, PVC bags are designed for parenteral nutrition, packaging of rehydration solutions (sodium chloride, glucose, lactated Ringer's solution, etc.) and some antibiotics and analgesics for hospital and veterinary use.

The flow of the medical film extrusion process is similar to that of medical bags, but the difference is that the extruded film is unique and a medical bag is not created immediately, but only later, when at the end of the extrusion, the films are wrapped with a calender. Most medical film production is made of PVC. This is because transparent PVC film has many advantages, including fire resistance, high quality, low cost, high transparency, good surface, no stains, less water ripples, high impact resistance and ease of shaping.

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