Medical Device Link.

Originally Published PMPN April 2005

NEWS

Medical device packagers attending this year's MD&M East show in New York City will have no shortage of new information at their disposal. The trade show, presented by PMP News parent company Canon Communications LLC, will feature a wide range of conferences and presentations in its medical device packaging track. Package and process validation, seal-strength testing, and risk assessment for sterile packaging are among the hot topics on this year's list of talks, led by a wide array of industry experts and professionals.

Package validation presenters will focus on the hierarchy of transportation and distribution testing protocols, their applicability to medical packaging, and the pros and cons of different approaches. Presentations include "Virtual Package Design: Reducing Development Time through Simulation," led by Peter Schmitt of Montesino Associates LLC; "How to Determine Minimum Seal Strength Requirements," led by Curt Larsen of DuPont; "Shelf Life Qualification: Accelerated and Real Time," led by Scott Levy of DDL; and "Physical Testing of Packaging Performance: Test Protocol Selection and Implementation," led by William Kipp of ISTA.

The package process validation track will be highlighted by a session entitled "Determining Optimum Sealing Parameters," by Don Barcan of DBI Inc. Barcan will discuss the scientific process for bar sealers, tray sealers, and form/fill/seal equipment. In addition to covering common packaging materials and methods for testing seal quality and strength, Barcan will talk about the one-pound minimum seal strength "myth" and its inaccuracies.

Another session, "IQ/OQ and Packaging Equipment Validation," led by John Abraham of Atlas Vac, will compare existing equipment, review calibration techniques, and help attendees understand operator-induced variables and validation equipment features. "Seal Strength Testing: Techniques, Effects, and Measured Values," led by Marie Tkacik of Tolas Health Care Packaging (Feasterville, PA), focuses on the findings of the analysis behind the new precision and bias statement of ASTM F88–Standard Test Method of Flexible Barrier Materials. Tkacik will discuss the evolution of the design, the analysis, the effect of technique on measured values, and the observations that helped form the appendix of the document.

Finally, Hal Miller of PACE Solutions will present a "Risk Assessment Program for Sterile Packaging." This newly-developed program provides packaging professionals with a tool to assess level of risk in the areas of material qualification, supplier quality, package design, testing, equipment and systems, and process design and control.

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