HealthPack 2013, dedicated to issues and new technologies in the area of medical device packaging, will take place March 12-14 in Louisville, KY. A March 12 UPS Worldhub tour from 11:15 a.m. to 4:30 p.m will be followed by a two-day conference program combined with tabletop exhibits to provide opportunities to focus on key industry issues while addressing individual needs with leading suppliers and service vendors.
Below is a look at the Louisville agenda, as of Jan. 7, 2013, which is subject to change:
Tuesday, March 12
Attendee registration and exhibitors set-up; 11:15 a.m. to 4:30 p.m., tour of UPS World Hub and Healthcare Logistics facilities.
Wednesday, March 13
• Keynote speaker, Joyce Hansen, vp of Sterile Process Technology, Johnson & Johnson. She will provide insights on how Johnson & Johnson views and utilizes the disciplines of Sterilization Science and Packaging Engineering. She will discuss initiatives that J&J is planning and has in place to take advantage of these two vital technologies.
• Voice of the Customer—Part III: Jennifer Foreman, medical device applications specialist, Medical Applications Division, Sealed Air Corp.
• Mackenzie Lussier, Masters candidate, Clemson University. A team of Clemson University packaging students will be performing a study within the medical packaging industry and its customers regarding issues that affect packaging system design efforts.
• Voice of the Customer—Part IV, Jennifer Neid Benolken, CPP, Smith Medical. Includes Q&A with nurse panel participants and live, unrecorded, and unfiltered opinions about packaging systems submitted to a group of nurses.
• Global Standards: Hear an update of the recent activities and initiatives from representatives of ASTM International, AAMI/ISO, Healthcare Plastics Recycling Council (HPRC), and ISTA.
• A visual sterile barrier system seal correlation to ASTM F1886, Richard Brady, PhD, Oliver-Tolas. An overview of a new technology offered by a sterile packaging manufacturer with contrasting seal technology. The presentation will include a correlation to ASTM F1886 and the outcome of a simulated surgery at Michigan State University using their proprietary technology.
• Regulatory recalls for medical device packaging. Patrick Weixel, Postmarket Team Leader, Division of Radiological Health
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.