Medical devices are complex by nature and designed to assist in healing the human body. Therefore, these devices have the highest quality standards and are subject to stringent regulations. In addition, staying cost effective and employing sustainable manufacturing practices are emerging needs for Medical Device Manufacturers (MDM). Dukane, as a provider of assembly solutions to the MDM industry recognizes these requirements and provides its customers with the most advanced assembly solutions and plastic welding technology. Dukane’s equipment options are designed to provide the best quality welds for the most complex of medical devices and components. Dukane’s welding systems are FDA compliant and offer advance process controls, which increase repeatability, deliver consistent part geometry, and reduce scrap rates. In addition, Dukane collaborates with MDM clients to provide technical expertise in assembly method selection, assistance in joint design, feasibility studies, welding systems validation and calibration.
Dukane’s iQ Series Servo Driven Ultrasonic Welder, with patented Melt-Match® technology, has a proven track-record of delivering quality results in welding medical parts like valves, ports, filters, surgical instruments and implant devices. iQ Servo’s patented process control features like Melt-Detect™ confirms the presence of the molten material in the contact area before prompting the press to initiate downward movement. This is especially important in welding small parts and assemblies, which require a hermetic seal, as it eliminates the risk of deforming the energy director before melt is initiated, which could result in a leak path and “cold welds”.
The Melt-Detect™ also enables a user to accurately establish the necessary amplitude required by specific material properties and part configuration by using the welder’s graphic output. This authentic approach for amplitude setting allows the user to apply just the right amount of ultrasonic energy that is needed to initiate the melt, avoiding excessive heating and material degradation in the weld. This is especially important for building filter assemblies, where excessive amplitude is associated with tiny pin-holes occurring in the filter media.
|Medical Devices and Components Assembled using Dukane’s Welding Technologies|
In addition, iQ Servo technology eliminates the variability associated with pneumatic press components resulting in improved process repeatability and accuracy, which results in fewer rejects for manufacturers. The elimination of compressed air in Dukane’s ultrasonic welding systems significantly simplifies equipment installation and lowers manufacturing cost.
Dukane’s Laser welding systems are capable of welding clear-to-clear and clear-to-colored parts, including typical tube-to-tube-and tube-to-port assemblies. In general, the laser welding technique is dependent on the upper component being transparent to the laser and having the presence of an absorbing agent in the lower component. This configuration limits the process applicability for manufacturing medical devices when a “clear-to-clear” or a “clear-to-colored” assembly is required. Dukane engineers have successfully overcome this obstacle by integrating a recently developed 2-micron laser. This laser produces a beam which is greatly absorbed by clear polymers and enables a highly controlled melt through the thickness of optically clear parts. It has resulted in a greatly improved and simplified technique for laser welding of clear polymers for the medical device industry, which now can fully capitalize on the benefits of this advanced Laser assembly process.
For more information on Dukane’s Welding technology and technical expertise call 630-797-4900 or visit http://www.dukane.com/us/AP_Med.htm