Multilayer extrusions are used to fabricate specialised packaging film and
tubing that is compatible with therapeutic agents.
as well as US FDA and CE marking. The CE mark, for instance,
confirms that a product has met EU consumer safety, health
or environmental requirements. Furthermore, additional legal
requirements must be considered such as a quality management
system that allows product recalls in case of a safety issue.
Consider current extrusion trends
A medical device manufacturer also should ensure that the supplier is up to speed on current trends in medical extrusion and
that it possesses the appropriate technology and expertise. “Many
extrusion companies now offer added value in terms of further
processing,” Ziembinski says. “Few medical device companies
purchase tubing on reels or as coils for further processing in their
own assembly processes,” he says. “Especially in catheter applications, the provision of [additional] assembly processes is expected
from tubing suppliers.” He explains that this includes technologies
such as printing, cutting, stamping drainage holes, thermoforming, tip-forming and special packaging.
Another trend is the demand for ever-tighter tolerance require-
ments, according to Kenneth Koen, Director of Extrusion Opera-
tions at Creganna-Tactx Medical. “Our customers have asked for
tubing walls to be as thin as 0.0007 in. with a tolerance of 0.0003
in.,” he says. “This has really pushed extrusion engineers to ‘think
outside the box’ by designing precise tooling and implementing
new processing steps to assure the customer that the project will
be a success.”
According to Ziembinski, there is also a growing demand for
micro-tubes for the fabrication of catheters used in minimally
invasive surgery, life support devices for neonates and microfluidic
systems. “And there is an opportunity to [achieve] even tighter
tolerances on certain tubing,” he adds. “This is a result of greater
precision in extrusion technology but also in improvements of the
corresponding in-line measuring equipment.” 1
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