MARCH 2004








18 MARCH 2004



The meeting of the Medical Device Packaging Technical Committee (MDPTC) was called to order and opening remarks were made by the co-chairs, Curt Larsen (DuPont) and John Spitzley (Medtronic). There were 47 attendees.


Brief updates were then given by the chairs of the MDPTC task groups.


Sterile Packaging Integrity (Dr. Laura Bix – MSU):


The Committee on Sterile Package Integrity is currently proceeding with the idea of conducting a series of four experiments to examine microbial

penetration into thermoformed trays lidded with Tyvek.


-"Experiment zero" examines four different types of self-sealing septums

through which sterile agar is filled to determine which, if any, are viable

For use in the future experiments.


-In "Experiment one" the self-sealing septum that was determined to be best during the course of experiment zero is used to "aseptically" fill sealed, sterilized trays with agar in order to test the hypothesis that filling

technique does not have an effect on microbial growth.  In other words, this experiment will examine whether or not the filling technique results in

microbial growth.


-Experiment two exposes sterilized packages filled with agar to known

concentrations of microbes to determine what hole size allows microbial

penetration when pressure differentials are ‘low’.


-Experiment three exposes sterilized packages filled with agar to known

concentrations of microbes to determine what hole size allows microbial

penetration when pressure differentials are comparable to those that would be induced by air transport.


Other investigations will be conducted as questions arise, and members of the general committee (and subcommittee) are still providing input and

insight as to how experiments 2 and 3 should be designed.


Materials Specification Worksheet (Nick Fotis – Cardinal Healthcare):


Nick passed out copies of the latest draft template and examples of specifications which met the template guidelines. Copies of the guideline and sample specification sheets are posted on the MDPTC website for review and comment via the Material Specification task group link. The draft is in it’s final stages, so Nick would like to receive any inputs by June 1st. You can contact him at Nick.G.Fotis@cardinal.com


Industry and Regulatory Update (Hal Miller – PACE Solutions)


Hal Miller provided an industry and regulatory update which is also posted on the MDPTC website via the Industry and Regulatory task group link.


Industry Benchmark Study (Dennis Young – Dennis Young & Assoc.)


Dennis Young presented the complete results of the Industry Benchmark Study completed in 2002. The entire presentation is now available on the MDPTC website via the Benchmark Study task group link. Also indicated that it was still too early to consider a follow on study and that at least another year should pass before we begin working on it.


Labeling Task Group (Dave Olson -   Web Graphics)


Dave Olson introduced Elizabeth Kempen of Alquest who gave us an overview of regulatory requirements for medical device packaging. She took us to the FDA website and provided navigational tips about the site and where to find the information that you need to developing labeling which meets FDA requirements. Her presentation can be found at the MDPTC website via the Labeling task group link.


Lastly, we had a brief discussion about the time and place for the next MDPTC meeting. All indications are that it will be at Pack Expo this fall. Details will follow by E-mail and the MDPTC web site.


The meeting was adjourned.


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