why is there new emphasis on moisture permeation in pharmaceutical packaging? Moisture permeation is a common problem that can impact the quality of the drug product, so having a more accurate and reproducible method to determine how effective the packaging is at keeping moisture out will be a benefit to industry. USP is revising General Chapter <671> Containers-Performance Testing to include a new method for determining moisture permeation for high and low-barrier pharmaceutical packaging. The current method in the general chapter, which is gravimetric, is well entrenched-used by FDA and widely by manufacturers, packagers, and repackagers-so the changes will have an impact. USP is also considering changing the USP classification system for packaging, which now is limited to "well-closed" and "tight" containers.
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