Novel Ideas and Data-Driven Methods at Kilmer Conference 2022



Kilmer Conference

Last week I had the pleasure of attending the Kilmer Conference, a 3-day conference dedicated to the disciplines of sterility assurance, microbiology, and chemistry. This year was the first time packaging played a prominent role in the agenda. Thanks to the Kilmer Innovations in Packaging Executive Committee, multiple KiiP groups presented on projects, findings, and significant contributions to the healthcare packaging space. In addition, discussions generated novel ideas around continuity and challenging the status quo. Here are a few presentations that stood out.  

Wicked Stability: Modeling material aging mechanisms presentation given by Rod Patch (Sr Director, Package Engineering Johnson & Johnson Vision and Henk Blom (VP, Research & Technology, Paxxus)  

With additional support from Jordan Montgomery – Medtronic and Dan Burgess – Boston Scientific who were not in attendance, this presentation offered compelling scientific rationale for eliminating stability testing in commonly used packaging materials. The evidence-based approach is being explored with regulatory officials to study options for industry-wide implementation of this practice. Initial benefits of the implementation would reduce resource needs, speed up launch timelines, remove redundant efforts, and eliminate unnecessary packaging waste used for testing.

Kilmer conf 2022

Reducing EO Fugitive Emissions from PKG & Shipping Materials, presented by Stacy Bohl (Technical Lead, Global Sterility Assurance, Boston Scientific).  

This presentation explored data showing that wood pallets absorb a significant amount of EO during the sterilization process. By moving to HDPE reusable pallets, EO fugitive emissions decreased by 90 percent. The example scenario of 50,000 HDPE pallets per year (replacing the same number of wood pallets) undergoing EO sterilization would result in a reduction of 600,000 g or 1322 lbs less EO contributing to fugitives. Depending on the supply chain logistics within your organization, this could be low-hanging fruit to meet sustainability goals. 

Long Term Implantable Medical Devices Sterilized with VHP: The Impact on Material Stability given by Kim Chaffin, VP corporate Technologist  

Medtronic shared how using a novel window of VHP can achieve optimal sterilization conditions while improving cycle time, temperature, and residual levels of devices. One main concern of VHP has been the inability to penetrate devices in a way that covers all nooks and crannies. This novel window has proven effective in initial research, raising confidence in the goal to successfully convert 74,000 legacy devices to new sterilization chemistries.  

If you are interested in additional work the Kilmer Innovations in Packaging is doing to solve problems in the healthcare packaging space, you can find more information here.   


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