EQUIPMENT NEWS
Balloon-forming equipment is suited for R&D and high-volume production
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A company that specializes in automating various catheter-manufacturing processes has announced the introduction of balloon-forming equipment. The system, which produces plastic catheter balloons from extruded tubing, is designed to improve productivity and product uniformity compared with conventional methods.
Balloons are blown by applying high-pressure nitrogen gas to the inside of balloon tubing, a section of which is inside a heated mould. The tubing stretches in such a way that the section of tubing inside the mould expands to conform to the mould’s shape. The system developed by Machine Solutions Inc. (MSI; Flagstaff, AZ, USA) allows the use of split or tubular glass or metal moulds. It is suited for use in R&D as well as production applications, according to the firm.
MSI has adapted its unique heating controls to the system to promote flexibility during process development. Spot heating along the mould length, uniform heating of the entire mould, or a combination of the two techniques can be accommodated. Simultaneous adjustable tube tensioning and/ or stretching produces balloons with optimal wall and shaft thicknesses. The user interface is designed with process development and operational ease in mind.
Catheter integrity inspection system is based on pressure generation
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An electropneumatic test device for inspecting performance aspects of catheters and similar medical products operates by measuring the rate of airflow through the piece under test and the pressure generated by the test. Available from Tecna S.r.l., headquartered in Mirandola (MO), Italy, the microprocessor-based Delta system can be used manually or can be controlled via a programmable logic controller or a personal computer. The latter capability enables the tester to be integrated into automated industrial processing lines.
This flow-rate tester features an output-pressure control that helps ensure that every test is conducted under the same conditions. Upon request, it can be programmed to perform special test cycles.
Tube-cutting machine handles jobs where automatic feed is impractical
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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. Everite Machine Products Company, Inc. (Philadelphia, PA, USA), 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 end-cut 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.
Flexible tubing can be cut at various feed rates
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A rotary-blade tubing cutter can be used to cut a wide variety of flexible tubing materials, including polyurethane, PVC, nylon-reinforced hose, and rubber hose having an outside diameter within the operational range of 12.7–28.5 mm. Manufactured by The Eraser Company, Inc. (Syracuse, NY, USA), the WC601D cutting system features a choice of feed rates to optimize productivity and accuracy. The operator can select which of five different feeds will be most appropriate for the application at hand.
The tubing cutter sections tubes according to the very tight specifications medical device applications require. Its belt feed prevents tubing material from being crushed either along its length or at the cut ends, and the rotary cutting head consistently produces clean, square cuts. A programmable batching feature enables as many as 99 processing programs for frequently run jobs to be stored in memory for recall as needed.
Functional testers check catheter performance against standards
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A company provides measuring and testing equipment designed to perform tests on medical disposables in accordance with the guidelines given in applicable ISO standards. Among the instruments Melab GmbH (Leonberg, Germany) offers for the testing of catheter systems in particular are the Dremo luer torque tester, Deka penetrometer, Kadi leakage tester, and Aqua-Flow flow-rate testing station. In addition, the company can itself conduct mechanical and functional tests of catheters as needed for product files, including in these laboratory services a record of protocols and a report of test results.
The luer torque tester and the luer reference gauges that also are available test the luer-lock fittings of catheters against ISO 594 and EN 1707. Other tests required by the catheter standard ISO 10555, including those for penetration force (DIN 13097), separation and bonding forces, and leakage and fluid-application force, can be performed using the penetrometer. This device is even suitable for high-pressure applications such as catheters for the administration of contrast fluid. The leakage tester is specialized for testing multilumen catheters.
The equipment supplier additionally offers 100% in-line testing equipment such as image-processing systems and a test instrument for checking leakage or the degree to which flow is blocked.
