Sterile Barrier Committee Meets in East Lansing, MI

The medical device industry has long struggled with the issue of what the minimum hole size is to maintain the sterile integrity of a sterile package. At present, any-size pinhole or open path in the seal is deemed to be a breach of sterile packaging integrity. Packages with any defects are subject to rejection prior to release, or recall after release to the marketplace. The costs of implementing and maintaining quality systems to effectively detect these anomalies at current sensitivity levels are significant and increase as production quantities rise.

At the request of, and in collaboration with, the Institute of Packaging Professionals (IoPP) Medical Device Technical Committee, the Michigan State University School of Packaging has developed and initiated a series of studies that explore this issue. The committee was first convened in 2003 to investigate microbial penetration in relation to hole size. Since that time, one master’s project at the school and a PhD dissertation have been completed with assistance of funding and guidance provided by the group.

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The long-term outcome of this work should be the objective definition of “potential for breach in sterility.” This knowledge may reduce potential economic losses from discarded or recalled devices that could be classified as “Defective packaging: Potential for breach in sterility.”

On November 2, 2006, the Sterile Barrier Committee met at the School of Packaging in East Lansing, MI, to discuss progress to date and plans for future research.

Attendance at the November meeting included the following companies:

• Advanced Test Concepts Inc. (ATC)

• Alcan (representing the Flexible Packaging Association)

• Becton, Dickinson and Co.

• Boston Scientific

• Cardinal Health

• DuPont Healthcare and Medical

• Medtronic

• Mocon

• Oliver Products Co.

• PACE Solutions

• Perfecseal

• Troedel and Associates

Member companies pay an annual fee to belong to the consortium that provides funding for the research. In exchange for the consortium fee, companies are invited to attend the annual meeting of the group.
The 2006 meeting provided an update of the following two student projects that were supported with this group’s help:

• The group was presented with an article that was the result of Ondrea Kassarjian’s thesis work. Kassarjian explored the effectiveness of three different techniques (optical microscopy, confocal microscopy, and electron scanning microscopy) for measuring hole size. Her findings and recommendations were presented.

• Jane Severin, PhD, provided the group with a review of her PhD dissertation, which investigated and confirmed the effect of hole size and pressure differentials on microbial penetration into lidded medical device trays. Additionally, the members of Dr. Severin’s dissertation committee, which included a statistician and a microbiologist, were available for questions and discussions with the group.

After the presented research, the group prioritized and vocalized ideas and needs for future research. Next steps will include evaluating the effects of porous lidding and secondary packaging. The group’s top priority for funding is being drafted into an experiment that will serve as the project for the next funding cycle.

For information on joining the consortium, please contact Laura Bix, PhD, at 517/355-4556 or by email at bixlaura@msu.edu.

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