Although SUSs offer increased flexibility, reduced contamination risk and lower operating costs compared with traditional stainless-steel systems, they also bring potential safety concerns related to extractables and leachables (E/L) — chemical substances that can migrate from plastics into drug products.
Sandi Schaible (pictured), Executive Director, Analytical Chemistry and Regulatory Toxicology at NAMSA, reports.
With the impending implementation of the United States Pharmacopeia (USP) chapter <665> in 2026, drug manufacturers worldwide must take note.
These standards are shaping global regulatory expectations and could have broader implications as regulators in Europe and beyond look to harmonise their guidelines. Here’s how the industry can prepare for this evolving legislation.
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