HealthPack 2013 Louisville preview
Office of In Vitro Diagnostics Devices, CDRH, US FDA. An FDA officer presents audit findings and recall data related to medical device packaging and labeling.
• IoPP Medical Device Packaging Technical Committee (MDPTC) meeting. (Follows 15 minutes after the final conference session in same meeting room.)
Thursday, March 14
• Case studies and practical interpretations of ISO 11607: Gerry Gunderson, Todd Engelken, QTS. Case Studies on the effects of the medical device packaging process relative to ISO 11607-1:2006. It will include real life comparisons of various customer issues and how their decisions were impacted by applying this standard. It will include a discussion of the rationale behind different interpretations of methods and guidelines written within the standard.
• Counterfeiting practices within the medical device industry—benchmarking and state of the industry, Karen Greene, Life Packaging Technology.This presentation includes a non-statistically significant survey of various medical device companies regarding their current corporate strategies to combat product fraud. Included will be a summary of research into anti-counterfeiting strategy—Trends and Regulation and highlights of anti-counterfeiting and product fraud technologies and strategies available and in development for the medical device packaging professional.
• Can Your Sterile Barrier System Be Your Label? Russell Darley—new technology in labels for your packaging components to include a non-statistically significant survey of various medical device companies regarding their current corporate strategies to combat product fraud. Included will be a summary of Dr. Spink’s research into anti-counterfeiting strategy—trends and regulation and highlights of anti-counterfeiting and product fraud technologies and strategies available and in development for the medical device packaging professional.
• My SBS material just changed—what now? Dr. Henk Blom, director of technical services, Rollprint. What tests, evaluations, and considerations should packaging engineers use when they are confronted with supplier, resin, or processing changes in sterile barrier system materials?
• Optimization of Tyvek® for EtO sterilization, Denise Dacey, sterilization scientist, Johnson & Johnson. An algorithmic method has been created to evaluate the sterilization potential of various size Tyvek header bag/sterile barrier systems in a defined EtO cycle. It considers the volume of the SBS, area of Tyvek in the system, porosity, and cycle specifications.
• Test method correlation, Jordan Montgomery, Medtronic. Considerations regarding test methods, intervals, and frequencies for inspection and process controls for SBS sealing operations.
• Impulse heat sealer validation, Jan Gates, Packwise Consulting. What should you look for in equipment and what are the issues and challenges involved with the validation process for impulse heat sealers?
• Conference farewell, John Spitzley and Curtis Larsen. Includes announcement of 2014 location and prize drawings.
















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