Tubing used in medical devices often has unique requirements that can push extrusion machinery to the limit. Here is what a few experts recommend you look for when sourcing equipment for making tubing in-house.
 |
|
The ability to control concentricity and wall thickness tolerance of extruded medical tubing is essential, according to Guill Tool & Engineering Company Inc.
(Photo courtesy GUILL TOOL & ENGINEERING) |
Approach the Purchase as an Investment
There is no getting around it: Extrusion equipment is expensive. So it is important to make sure the equipment you purchase can support your business for many years to come, says Luann Kupka, Director of Marketing for Davis-Standard GmbH (Erkrath, Germany). She suggests that medical device companies look for extrusion machinery that can be easily upgraded or adapted to match changing processing requirements.
Consider the Manufacturer’s Experience
The reputation of the extrusion equipment manufacturer is something else to keep in mind. You should look for a reputable firm that has been in business for a long time and is involved in every area of extrusion, Lupka advises. “Consistent equipment performance speaks louder than words,” she says.
Medical device companies also should make sure that they partner with an extrusion tool supplier that has a history of working with medical applications, says Steve Blanche, Sales Manager at Guill Tool & Engineering Company Inc. (West Warwick, Rhode Island, USA). “The extrusion tool supplier must be able to offer the medical device manufacturer experience in designing single and multiple layer tooling that provides a balanced flow of materials extruded to the face of the die,” Blanche explains. “The ability to control concentricity and wall thickness tolerance to ensure the quality and performance of extruded medical tubing is essential,” he adds.
Research Equipment Capabilities
“Do a side-by-side comparison of extrusion systems to make sure you’re getting the best value for your process,” Kupka recommends. “Consider functionality and capabilities as well as construction.” Make sure the machinery achieves the type of quality and processing rates you are seeking and that the equipment is durable enough to minimise downtime, she adds.
While extruding thin-walled products such as medical tubing, significant diameter variations can result from minimal pressure changes, notes Bruno Mülheim, spokesperson for Zumbach Electronic AG (Orpund, Switzerland). On-board data collection can help you keep track of any deviations from specifications, he says.
“You should look for machines that can handle single and multilayer coextrusion for a wide range of products,” says Bao Nguyen, product manager for medical tube extrusion at Maillefer Extrusion (Ecublens, Switzerland). “Extrusion machines should provide homogeneous melting and a precisely controlled temperature,” he adds. Nguyen also recommends checking that the machine’s extrusion head is easy to mount and dismount.
Match Extrusion Systems to Your Applications
When it comes to extrusion equipment, one size does not fit all. “Make sure your supplier has a thorough understanding of your process and the technical knowledge and expertise to support it,” Kupka recommends. Look for a company that is equipped for a range of applications including single-lumen microtubes, multilumen tubes and microcatheters using materials such as fluorinated ethylene propylene, flexible poly(vinyl chloride) and polyetheretherketone.
Consider After-Sale Support and Service
Medical device manufacturers also should consider the support that the extrusion equipment manufacturer offers. “Ideally, the company should offer international customer service that is available 24 hours a day, seven days a week,” says Kupka.