Right now, manufacturers of drug and packaging combinations have the option of filing with FDA under USP 661, Plastic Packaging Systems and Their Materials of Construction, or the new USP 661.1, Plastic Materials of Construction. Starting in May 2020, however, “all drugs marketed in the United States and their packaging will need to be in compliance with 661.1,” said Stephen Duckworth, Head of Segment, Healthcare Polymer Solutions, at specialty chemicals company Clariant (Muttenz, Switzerland). To help its customers get in front of these regulatory changes—and they are considerable, stressed Duckworth—Clariant began testing its MEVOPUR and REMAFIN-EP materials last year to the USP 661.1 requirements, a process that it has now completed. Duckworth spoke with PlasticsToday about Clariant’s initiative to help customers future-proof packaging before the May 2020 deadline from the company’s booth at the co-located MD&M West and PLASTEC West event in Anaheim, CA, this week.
“As of December 2017, those materials have been tested to the new 661.1 standard, and we can provide all of that data to customers now,” Duckworth told PlasticsToday. Compliance to the new standard is more rigorous, he added, as it involves a modernization of test methods as well as a more robust risk assessment process. It is especially important to know that food-contact statements, which long supported materials used in drug packaging, are no longer sufficient. Packaging materials for any category of drugs, from solid dose to higher risk ophthalmic solutions, will have to be supported by data from in vitro tests specified in USP 661.1 and USP 87 for cytotoxicity, according to a news release from Clariant.
Data captured from the tests also support the guideline for risk assessment of elemental impurities published by the International Council for Harmonisation. “The ICH-Q3D guideline strengthens the risk assessment process by evaluating not only the pharmaceuticals, but also the packaging to ensure it is not a source of impurities in drugs,” explained Duckworth. As stated in the ICH-Q3D guideline, “the identification of potential elemental impurities that may be introduced from container closure systems should be based on a scientific understanding of likely interactions between a particular drug product type and its packaging. When a review of the materials of construction demonstrates that the container closure system does not contain elemental impurities, no additional risk assessment needs to be performed.” The document singles out liquid and semi-solid dosage forms as having a “higher probability that elemental impurities could leach from the container closure system during the shelf-life of the product.”
While manufacturers must prove compliance of finished pharmaceutical packages and drug-delivery devices to the new standard, using MEVOPUR and REMAFIN-EP in those products provides them with an added measure of confidence that the package concept will comply with the new regulation, said Duckworth.
Clariant also recently announced the start-up of a high-throughput twin-screw compounding extruder at its facility in Lewiston, ME. The upgrade enables the Lewiston plant to more rapidly produce larger batch sizes of MEVOPUR pre-colored medical plastic compounds. “People know us for our master batches and concentrates, and not as much as a compounder,” said Duckworth. “Customers often buy concentrates from us and send them to a compounder. We want to give them the choice of going through a single source.” To learn more about the company’s U.S. compounding capabilities, read “Clariant increases capacity for medical-grade compounds at Maine plant.”