By Erik Swain
An ASTM International (West Conshohocken, PA) task group has begun work on developing standards that could be used with FDA's upcoming guidance on packaging post-approval changes, known as PACPAC.
FDA's 1999 guidance on post-approval changes outlines reporting requirements for different kinds of postapproval changes and allows some packaging postapproval changes to be made without redoing full stability studies. PACPAC would outline what tests could be performed in lieu of stability studies. The ASTM task group aims to develop methods for tests likely to be recommended by PACPAC that do not have standards.
The task group, part of ASTM subcommittee D10.32 on Consumer, Pharmaceutical, and Medical Packaging, met in Kansas City, MO, on April 8, 2003. At that time, Julie A. Clifford, co-chair of the task group and manager of package development for Alcon Laboratories Inc. (Fort Worth, TX), presented drafts of the first five proposed methods to be considered by the task group. (See this issue's Interview with Julie Clifford, p. 30.)
Two of the proposed test methods are for evaluating package extractables; one by high-performance liquid chromatography, the other by gas chromatography. The other three are for evaluating the drop size of aqueous solutions and suspensions, determining a reclosable container's permeable surface area-to-overflow volume ratio when the seal is intact, and determining a reclosable container's permeable mass-to-overflow volume ratio when the seal is intact.
Clifford asked the task group members to review the proposals and submit comments so that the proposals may be refined for the next meeting, October 20-21, 2003, in Tampa, FL.
The task group also expects to work with the Product Quality Research Institute (PQRI; Arlington, VA) on developing a standard related to calculating moisture vapor transmission rates (MVTR). "PQRI is actively working to collect data on anything related to MVTR and formulate basic guidelines and a fundamental methodology. We will probably take that information and translate it into some sort of standard," Clifford said.