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Clariant will present future-proofing for drug packaging and delivery devices at MD&M 2018.
Clariant will present "future-proofing" for drug packaging and delivery devices at MD&M 2018.

Switzerland specialty chemicals company Clariant will present its MEVOPUR and REMAFIN-EP products for "future-proofing" pharmaceutical packaging and drug-delivery devices in advance of new USP<661.1> regulations at MD&M West 2018.

The US Food & Drug Administration (FDA) allows the industry to make new filings under the older USP<661> or the new <661.1>, but by May 2020, requires all drugs and their packaging materials to be covered by <661.1>.

"Clariant understands the impact of the USP <661.1> regulations and is already working well in advance to ensure that our customers and their packaging strategies remain well ahead of the game," said Eric Rohr, who recently joined Clariant as North America Segment Manager, Medical & Pharmaceutical.

Clariant have completed USP<661.1> compliance testing for pigment and additive ingredients in our change-controlled MEVOPUR and REMAFIN-EP product ranges for pharmaceutical packaging applications.

"The availability of compliant and change-controlled ingredients today means we can help pharmaceutical customers get out in front of these regulatory changes and avoid the potential for last-minute problems with <661.1> testing as the 2020 deadline approaches," said Rohr.

Clariant has been appointed a distributor of the Bormed solutions of dedicated healthcare polyolefins produced by Borealis. Under the new distribution agreement, Clariant can now sell the complete Bormed portfolio of homopolymer and random copolymer polypropylene (PP) as well as high density and low density polyethylene (HDPE, LDPE) resins.

Besides the natural resins, Clariant can offer Bormed resins as ‘ready to use’ MEVOPUR compounds, combining the change control and compliance attributes of both product ranges.

Bormed solutions are used in a range of medical devices, diagnostics and pharmaceutical packaging – including syringes, inhalers, IV bags dialysis filters, pipette tips, and packaging such as bottles and Blow-Fill Seal (BFS) vials.

"The Bormed service package from Borealis complements Clariant's MEVOPUR promise for medical devices and packaging," said Rohr. "They are change-controlled, produced to consistently high standards, and tested for assured compliance with relevant European and US Pharmacopeia and ISO standards."

He noted that customers who select Bormed solutions for use in MEVOPUR compounds or a Bormed resin for self-coloration with a MEVOPUR concentrate will receive change notification and regulatory support and compliance documentation from both Clariant and Borealis, based on the materials involved.

Apart from polyolefins, medical device manufacturers can leverage the good dielectric properties, lubricity and biocompatibility of fluoropolymers to meet the demanding requirements of their devices.

Clariant has commissioned a dedicated line for fluoropolymer compounds and concentrates at one if its ISO13485 sites in Lewiston Maine, the US. The site is now supporting developments in applications such as tubing used for minimally invasive surgical devices, and acts as a global competence center supporting customers both inside and outside North America.

MD&M West 2018 will be held from February 6-8 in Anaheim, the US.

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