Dec 16, 2008

While drug products must be tested for chemical and physical stability in their market packages, the testing process can be long and expensive. A proposed new ASTM International standard under the jurisdiction of Committee D10 on Packaging will provide a quick and accurate method to minimize the necessary package testing. The proposed standard, WK21601, Test Method for Measuring Water Vapor Transmission Rate of Bottles and Blisters by Gravimetric Method, is under the jurisdiction of Subcommittee D10.32 on Consumer, Pharmaceutical and Medical Packaging.

“WK21601 will provide the means to determine comparative data to evaluate water vapor barriers,” says Hugh Lockhart, professor emeritus, School of Packaging, Michigan State University, and a member of the container closure working group of the Pharmaceutical Product Quality Research Institute. Lockhart, a longtime member of D10 and chair of the task group working on WK21601, says that the proposed standard will enable accurate, precise evaluations quickly at minimum cost and will allow for greater discrimination of results for high barrier formed and sealed packages.

Lockhart notes that WK21601 will be used by those involved in the manufacturing, packaging and marketing of both prescription and over-the-counter medications. “When fully instituted the proposed test method will become a part of the common protocol for assurance that the drug supply is pure, safe and effective,” says Lockhart.

Interested parties are invited to participate in the activities of the WK21601 task group. In particular, the ASTM group would be interested in help with evaluating the proposed standard for applications beyond drug packaging. In addition, Subcommittee D10.32 welcomes participation in its other standards developing activities.

For technical Information, contact Hugh Lockhart, Michigan State University, East Lansing, Mich. (phone: 517-394-2642; lckhrt@msu.edu). Subcommittee D10.32 meets at ASTM International headquarters in West Conshohocken, Pa., on May 12, 2009. For ASTM meeting or membership information, contact Kevin Shanahan, ASTM International (phone: 610-832-9737; kshanaha@astm.org).

Release #8128/Dec08