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Clariant's healthcare solutions.
Clariant's healthcare solutions.

Clariant recently announced the completion of testing on ingredients in its MEVOPUR and REMAFIN-EP product ranges in order to bring them into full compliance with United States Pharmacopeia chapter 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 US 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.

“Because of Clariant’s commitment to the continued availability of ‘controlled, consistent, and compliant’ ingredients through our MEVOPUR and REMAFIN-EP color concentrates and compounds, we initiated the required testing for the USP661.1, ICH-Q3D elemental impurities and the European Pharmacopeia in 2017 and completed it early this year,” said Steve Duckworth, Global Head of Healthcare Polymer Solutions, Clariant Business Unit Masterbatches.

Duckworth pointed out that for Chinese pharmaceutical companies wishing to export to USA or Europe, having packaging materials that fulfil the future requirements will help save time and significant costs.

During the transitional period, the FDA allows pharmaceutical companies to make new drug application filings with packaging materials tested 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 explained.

He added that compliance to <661.1> represents a major change, involving not only new requirements but a significant modernization of test methods.

“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. For higher risk classes, additional tests such as USP<88>biocompatibility are also needed.”

Though all manufacturers must prove the compliance of their finished pharmaceutical packaging and drug delivery devices to the new standard, Duckworth said that customers who select MEVOPUR and REMAFIN-EP products to provide the color for plastics used packaging or drug delivery devices can develop and test their products with an added measure of confidence knowing that the Clariant products have declarations that support both US and European requirements.

In the longer term, Duckworth noted that the GMP 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.

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