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I am new to medical device packaging. Why do so many products have porous windows in their packaging even though they are not gas-sterilised?

There are legacy PVC medical device products on the EU market that have been used in large volume over at least the past three decades with, presumably, no deleterious effects. They would be expected to fail the current 10993 testing (as PVC is used as a

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Published: May 14, 2010

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Compounder Expands Line of Transparent Medical TPEs

New easy-flow grades have been added to a line of oil-free thermoplastic compounds for medical applications. Part of the VTC TPE Group’s Mediprene OF series, the grades are currently available in hardnesses of 60 to 90 Shore A. Harder and softer formulations can be accommodated on demand. The new grades are transparent and contain a minimum of potential extractables and leachables like all Mediprene OF compounds, but they have a higher melt-flow rate than other materials in the family. This property makes them suitable for moulding thin-walled parts.
VTC TPE Group
Amal, Sweden +46 5 32 607 500
www.elastotpe.com

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