6 Feb 2018
Clariant MEVOPUR® and REMAFIN-EP® Ingredients Fully Comply With 2020 USP<661.1> Requirements
- Ingredients testing completed ahead of USP<661.1> 2020 deadline
- Tests support ICH-Q3D risk assessment process for drugs and packaging
- Dedicated ISO:13485 production plants assure consistency, change control
Muttenz, February 6, 2018 – Clariant, a world leader in specialty chemicals, announces completion of testing on ingredients in its MEVOPUR and REMAFIN-EP product ranges in order 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 <661> 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, Duckworth explains.
He adds that compliance to <661.1> represents a major change, involving not only a significant modernization 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<87> for cytotoxicity.”
Though all manufacturers must prove the compliance of their finished pharmaceutical packages and drug delivery devices to the new standard, 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, 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.
- Pharmapack at Booth E14 – The Pharmapack 2018 even is being held in Hall 7.1 at Porte De Versailles, Paris, France, from Feb. 6-8.
- MD&M West at Booth 2049 – The Medical Design and Manufacturing show is being held at the Anaheim Convention Center, Anaheim, CA from Feb. 6-8.
- PlastIndia in Hall 2, Booth H2A12 – The PlastIndia 2018 event is being held at the The Exhibition Centre, Gandhinagar, Gujarat from Feb. 7-12.
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Notes for editors
Clariant is a globally leading specialty chemicals company, based in Muttenz near Basel/Switzerland. On 31 December 2016 the company employed a total workforce of 17 442. In the financial year 2016, Clariant recorded sales of CHF 5.847 billion for its continuing businesses. The company reports in four business areas: Care Chemicals, Catalysis, Natural Resources, and Plastics & Coatings. Clariant’s corporate strategy is based on five pillars: focus on innovation through R&D, add value with sustainability, reposition portfolio, intensify growth, and increase profitability.