Clariant offers breakthrough drug packaging

Clariant is set to show off 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 Feb. 6-8 at the Anaheim Convention Center, Anaheim CA.

 

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.”

 

Mr. 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 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.