Clariant, a world leader in specialty chemicals, will share how its Mevopur and Remafin-EP products can help in ‘future-proofing’ pharmaceutical packaging and drug-delivery devices in advance of new USP<661.1> regulations at the upcoming MD&M West exhibition.
Experts from Clariant’s Healthcare Polymer Solutions will be on hand in Booth 2049 at the medical device trade show being held from February 6-8 at the Anaheim Convention Center, Anaheim, California.
An important topic at MD&M 2018 will be the need for drug makers to prepare to re-test and re-certify plastic materials used in packaging and drug-delivery-devices for all new and existing drugs per USP<661.1> by May 2020. By granting a transitional period, the FDA allows the industry to make new filings under the older <661> or the new <661.1>, but by 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,” says Eric Rohr, who recently joined Clariant as North America Segment Manager, Medical & Pharmaceutical. To that end, he adds, “We have already 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.”
Rohr says that completion of the tests for these ingredients opens new options for manufacturers contemplating changes in drug packaging. “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.”
Clariant has been appointed a distributor of the Bormed solutions of dedicated healthcare polyolefins produced by Borealis (Vienna, Austria). Under the new distribution agreement, Clariant can now sell the complete Bormed portfolio of homopolymer and random copolymer PP as well as HDPE and 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, which 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 — are a comfortable fit for Clariant. “The Bormed service package based on Borealis’ commitment, service and compliance to the healthcare industry complements Clariant’s Mevopur promise for medical devices and packaging,” says 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 notes 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.
Similar to the highly demanding applications in aerospace, medical device manufacturers can leverage the good dielectric properties, lubricity and biocompatibility of fluoropolymers to meet the demanding requirements of their devices. However, melt-processable fluoropolymers such as FEP, ETFE and PVDF require special processing equipment and manufacturing techniques.
As part of Clariant’s strategy to offer a wide range of solutions to the healthcare industry and support the demand for coloration of these high temperature resins, Clariant has commissioned a dedicated line for fluoropolymer compounds and concentrates at one if its ISO13485 sites in Lewiston Maine. 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.