Clariant MEVOPUR® and REMAFIN-EP® ingredients fully comply with 2020 USP requirements
Clariant, a world leader in speciality chemicals, has announced the completion of testing on ingredients in its MEVOPUR and REMAFIN-EP product ranges to bring them into full compliance with USP <661.1>.
The new standard for pharmaceutical packaging and drug delivery devices doesn't take effect until May 2020, when it will impact all current and future drugs on the U.S. market. Clariant is completing the testing process now to help customers "future-proof" packaging launched in the interim and, in addition, to offer data to support the ICH-Q3D guidelines for risk assessment of elemental impurities in drugs.
"The ICH-Q3D guideline strengthens the risk assessment process by evaluating not only the pharmaceuticals themselves but also the packaging to ensure it is not the source of elemental impurities in drugs," says Steve Duckworth, Global Head of Healthcare Polymer Solutions. "As part of Clariant's commitment to the continued availability of 'controlled, consistent, and compliant' packaging ingredients through our MEVOPUR and REMAFIN-EP product ranges, we initiated the required testing in 2017 and completed it early this year.
“During the transitional period, the FDA allows the industry to make new filings under the older or the new <661.1> standard, but in 2020, all existing and new drug/package combinations will need to be tested and compliant to the new standard. By completing its testing early, Clariant is helping 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,” Mr Duckworth explains.
Mr Duckworth adds that compliance to <661.1> represents a major change, involving not only a significant modernisation of test methods, but also a more robust risk assessment process: "The major consequence of this change is that in 2020, the 'food contact statements' that have long supported the use of many materials in drug packaging will be deemed 'insufficient' to support their future use.
Thereafter, packaging materials for any category of drugs, from solid oral dose to higher risk ophthalmic solutions, must be supported by data from in-vitro tests specified in USP<661.1> (e.g. for extractable metals) and USP for cytotoxicity."
Though all manufacturers must prove the compliance of their finished pharmaceutical packages and drug delivery devices to the new standard, Mr Duckworth says that customers who select MEVOPUR and REMAFIN-EP products for use in those packages or drug delivery devices can develop and test their products with an added measure of confidence and avoid the costs of testing and submission twice: "If our own tests have already indicated that there is a low risk of an ingredient in the packaging interacting with the drug, then the customer can proceed with additional tests, such as required leachable and shelf life stability testing, with a greater confidence that the package concept is going to get through these tougher regulations."
Longer term, Mr Duckworth notes that the production controls in Clariant's ISO:13485 medical manufacturing plants help to ensure that MEVOPUR and REMAFIN-EP materials and ingredients remain free of change and thus supporting continuous compliance worldwide.
Experts from Clariant's Healthcare Polymer Solutions will be present at the following tradeshows to review the implications of the new regulation and consult with customers about packaging /drug delivery device design strategies.