The United States Pharmacopeial Convention (USP) and the Product Quality Research Institute (PQRI) are cosponsoring a workshop to address a proposed new USP method for measuring moisture vapor transmission rate. The workshop will be held May 20–21 at USP’s headquarters in Rockville, MD. Regulators and manufacturers use the moisture-permeation standards to determine the barrier protection afforded to medicines by their packaging.
“The ability to accurately assess the degree to which packaging shields a product from moisture is an important USP testing requirement for packaging systems,” said Dr. V. Srini Srinivasan, executive VP and chief science officer of USP, in a press release. “New changes to these standards are being proposed and are expected to have high impact. At this workshop, we will seek input from stakeholders (manufacturers, packagers, repackagers, regulators, and others) on new methods for measuring moisture permeation as well as related issues that may result in far-reaching changes to the standard in the near future.”
Package moisture permeation is a critical quality attribute for solid oral-dosage forms, and moisture uptake is a common cause for product-package failure. Current permeation methods in USP General Chapter <671> Containers—Performance Testing were developed for pharmacists in the 1970’s and are not robust, but the chapter is being revised to include a new permeation method for pharmaceutical manufacturers that is more reproducible and may be better suited for modern applications.
The USP–PQRI workshop will also consider USP’s classification system for pharmaceutical packaging, which at present is based on the categories of “well-closed” and “tight” containers. Certain drug products require protection beyond “tight,” which is one of the reasons an open discussion on the topic is necessary, noted USP.