New USP Requirements for Pharmaceutical Packaging Materials and International Standards for the Measurement of Material Permeability Indexes

This year, the USP has already published many new requirements for pharmaceutical packaging systems in the Pharmacopeial Forum (PF). For instance, the revision of the following two General Chapters was proposed:

Container Performance Testing - New Proposal for USP General Chapter <671> (also see GMP News from 18. September 2013)

In the Pharmacopoeial Forum 39 (2) a proposal for the revision of USP General Chapter <671> was published. It was proposed that this chapter will be revised to include a new permeation method for determining barrier protection for packaging systems. In addition definitions and moisture vapour transmission rates were given for low-barrier blister, high-barrier blister and ultra-high barrier blister.

A very good overview over Material Permeability Indexes can be found at the Labthink^® Website which gives a detailed introduction to this topic and includes the items

Material permeability
Gas permeability coefficient and permeation mass
Water vapour permeability coefficient and transmission rate

(Please see the Detailed Introduction to Material Permeability Indexes)

The related literature addresses Drug Packaging Materials and contains a huge list of applicable standards (ISO, ASTM, TAPPI, GB, DIN, etc.) that could be used for the determination of such permeability values.

In the Pharmacopeial Forum No 39(4), the USP has published a proposal for the revision of Chapter <659> on "Packaging and Storage Requirements", which provides definitions for the different types of packaging as well as storage conditions. See our GMP News dated 11.September 2013 for more details.

Besides the definition of storage conditions this draft also addresses the following terms as associated components: