The US Pharmacopoeial Convention (USP) and its co-sponsor Product Quality Research Institute (PQRI) will organise the Pharma Packaging Workshop on May 20 & 21, 2013 at Rockville Maryland. The recently proposed changes to widely used pharmaceutical packaging standards will be the focus of the workshop.

The standards will be addressed are specifically relied upon by regulators and manufacturers to determine the barrier protection afforded to medicines by their packaging from outside moisture permeation.

“Moisture permeation through the packaging of medicinal products can affect the quality of the final product for the patient, and is therefore a critical issue in the area of pharmaceutical packaging,” said Dr V Srini Srinivasan, executive vice president and chief science officer, USP.

“The ability to accurately assess the degree to which packaging shields a product from moisture is an important USP testing requirement. New changes to these standards are being proposed, and are expected to have high impact. At this workshop, we will seek inputs from stakeholders covering manufacturers, packagers and 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,” he added.

The USP and National Formulary compendia, provide the standards for the functional properties of packaging systems used for solid oral dosage forms for pharmaceuticals and dietary supplements via monographs. The general chapter is broadly used for more than compendial purposes as well, as it is referenced in the US Food and Drug Administration’s (FDA) 'Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologics'.

Through the general chapter, USP provides tests to determine the moisture vapor transmission rate (also referred to as water vapor permeation rate) of plastic containers. The method currently in place was originally developed in the 1970s for use by pharmacists dispensing medicines, as opposed to manufacturers. Additionally, the method utilises an older permeation test that is not very robust which can lead to inconsistent results. Given these factors, USP proposed revisions to General Chapter 671 via Pharmacopeial Forum (PF) 39 (2) [March–April 2013]. PF is the vehicle through which USP accepts public comments on proposed new standards. The revision proposes a new method for measuring moisture vapor transmission rate that is more reproducible and may be better suited for modern applications. Much of the method development work that formed the basis for this revision was conducted by PQRI over the course of the past decade.

In addition to the new method, the USP-PQRI Workshop will consider a second principal issue of 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” and this is one of the reasons conducting an open discussion on the topic is necessary.