Partly finished extrusions are the specialty of a company that works primarily with medical-grade plasticized PVC. Serving the medical disposables market, the extruder offers a PVC product range comprising medical-grade compounds, tubing, and lay-flat tubing, along with lay-flat tubing made of EVA. The PVC compounds for extrusion and injection moulding are available as standard and special formulations with hardness ranging from 50 to 95 Shore A and include gamma radiation–resistant, DEHP-free, and radiopaque versions. Clear and frosted PVC tubing is supplied in coils and cut to lengths of 10–2500 mm for use in infusion, blood, haemodialysis, catheter, peristaltic pump, drainage, nutrition, and other applications. The PVC lay-flat products are suited for the manufacture of various biological liquid bags, while the EVA lay-flats serve for total parenteral and enteral nutrition. All production takes place in a cleanroom environment, and extrusion processes are under statistical dimensional control. Hospital Tubing S.r.l., Marnate (VA), Italy.
Medical-Grade Plastic Tubes and Films
A range of medical-grade plastics consists of PVC-, polypropylene-, and EVA-based flexible films and tubing developed for a variety of critical medical device and packaging applications. Suitable for steam, EtO, and gamma sterilization, Solmed materials can be welded via high-frequency and radio-frequency methods or heat-sealed to produce flexible containers for blood products, IV solutions, enteral feeding systems, dialysis systems, and cell culture and biopharmaceutical applications. The products are manufactured under strict cleanroom conditions in a variety of formulations designed to comply with international standards and pharmacopoeial requirements. The Solmed line comprises PVC tubular film and tubing; polyolefin tubular film, flat film, and tubing; PVC film for blood bag systems, in DEHP and non-DEHP versions; EVA tubular film, flat film, and tubing; and high-barrier tubular film. Highly transparent and flexible Infuflex barrier films based on polypropylene or polyethylene also are available. Renolit Nederland B.V., Enkhuizen, Netherlands.
The latest in a line of electrochemical grinding (ECG) tube cutoff machines is well suited for trimming bent or swaged tube ends and performing trim cuts on catheters, guidewires, long cannulae, and various other medical device components. A company offers the TC3A as a machine to supplement its traditional automatic cutoff system. The TC3A can handle applications involving short lengths, low volumes, bevels, or endcut requirements for which an automatic-feed machine would not be practical. The self-contained cutoff machine is easy to use, rugged, compact, and designed for the production environment. Because its power supply, control system, and electrolyte tank are integral elements of the system, it consumes a minimum of floor space. The machine is offered to provide an economical entrée into burr-free ECG tube-cutting technology. Everite Machine Products Company, Inc., Philadelphia, PA, USA.
Tubing adapters feature a bore design that provides flow consistency. The inner diameters of the BioBard adapters facilitate drainage and reduce turbulence, while oversized singular barbs provide strong adhesion to the tubing. Compression between the tube and fitting eliminates bypass of media to potential entrapment areas. Permanent moulded lot and size identification on the adapters ensure traceability and prevent incorrect use. Part number, size, date of manufacture, and lot number are printed on the packaging for simple identification. The propylene units comply with US FDA and USP Class VI test protocols. Biopurtech, Havant, Hants, UK.
Thermoformed Tubing Assemblies
Thermoformed tubing assemblies can be custom designed with bends and coils to fit snugly without kinking into tight spaces. Samples, reagents, and other fluids pass smoothly through the tubing, which has been engineered to maintain the desired flow rate. The tubing has a one-way-fit design, ensuring that assemblies can only be installed in the correct orientation. A proprietary flaring process combined with appropriate hardware produces a leak tight seal. Materials such as FEP, PTFE, PFA, ETFE, PVC, TPU, and PEEK can be processed, and tight tolerances can be achieved on tubing measuring 0.010 to 0.875 in. ID and 1 in. OD. Diba Industries Inc., Danbury, CT, USA.
Crossheads and in-line dies can be used to produce precise, low-volume medical tubing with an inner diameter as small as 0.000508 cm. A proprietary distribution system eliminates potential manufacturing problems by achieving 95% or better concentricity, holding precise tolerances while reducing polymer use. Engineered for medical applications, the components can be used to produce tubing from a variety of compounds as well as resin and polymer combinations. The units offer a patented feather-touch adjustment mode that enables precise concentricity adjustment. All crossheads and dies include a multiport splitter with an optional Taperlock feature that provides a reduced extrudate memory set, low material inventory, balanced material flow distribution, and the elimination of dead spots. Guill Tool & Engineering, West Warwick, RI, USA.
Thermoplastic Tubing Welder and Sealer
Welding and sealing instruments have been introduced for connecting or disconnecting thermoplastic tubing in biopharmaceutical manufacturing processes. The BioWelder and BioSealer accommodate various types of thermoplastic tubing with outer diameters ranging from 1⁄4 to 3⁄4 in. They are designed for use in the manufacture of disposable products. The instruments feature automated operation and short cycle times. They allow users of disposable bag assemblies, for example, to intervene between the process steps without compromising process sterility. The thermal welds and seals ensure stability and sterility. The underlying technology, developed by Wave Biotech Switzerland with whom the manufacturer has a strategic alliance, will be integrated into the Gammasart BioSystems line of disposable sterile fluid–handling products. Sartorius AG, Göttingen, Germany.
A manufacturer of extrusion machinery suited for producing technical and precision tubes offers a line specialized for medical tubing. The PML line is designed to provide a stable and linear extrusion flow for a variety of compounds. All parts in contact with process water are made of stainless steel or other US FDA–compliant materials. The line feature coreless coiling at high speeds and is engineered not to cause deformation of tubes made from soft PVC. Tubes of one to three layers can be extruded in sizes of 1–12 mm OD, and can be striped or frosted. The line is suited for extruding thermoplastic urethane and FEP as well as PVC. Maillefer S.A., Ecublens, Switzerland.
A company supplies high-precision cold-drawn metal tubing from stainless steel, gold, platinum, titanium, copper, aluminium, and other implantable alloys. Outer diameters are offered from 0.1 to 10.0 mm and wall thicknesses from 0.015 to 1.00 mm. Medical device applications include stents, endoscopes, marker bands, implants, and diagnostic and biopsy equipment. The company is certified to ISO 9001:2000. Medelec, Puidoux, Switzerland.
Thermoplastic extrusions are produced in pyrogen-controlled Class 100,000 cleanrooms. The company’s capabilities include, SPC documentation, online measurement, an inhouse wire EDM CAD/CAM system, multilumen tubing, reinforced high-pressure tubing, co- and tri-extrusions and thermobonding. The PEXglide dual-layer tubing allows easier insertion and removal of guidewires, says the company. Filtrona Extrusion, Northborough, Massachusetts, USA.
A company produces a soft, high-pressure tube with high strength fibre braiding. The tubing is manufactured from thermoplastic polyurethane with nylon fibre reinforcement. The outer diameter is 3.65 mm and inner diameter is 1.85 mm. The tubing can be used as the main part of angiography extension lines and connects the contrast medium injector syringe to the angiography catheter. Maximum pressure is 84 bar, and the tubing has reportedly good softness and transparency. MS Techniques, Pompey, France.
