| Conference — Monday, February 8
9:00 AM - 4:00 PM (Lunch 12:00 PM - 1:00 PM)
ABOUT THE CHAIR Kevin Zacharias, Engineering Program Manager, Oliver-Tolas Healthcare Packaging Kevin Zacharias is an Engineering Program Manager at Oliver-Tolas Healthcare Packaging and is responsible for managing the Product Development Department as well as the OnSite package engineering services program. He has worked in medical packaging for over 17 years and his areas of expertise include package design and validation, process validation, simulated distribution testing, in-line printing systems, ISO 11607 and cost savings analysis. Before joining Oliver-Tolas, Kevin worked as Manager of Packaging Development at Baxter Healthcare and as a Packaging Engineer at Boehringer Mannheim (Roche) Diagnostics. Kevin holds a BS in Packaging from Michigan State University and an MBA from Butler University. He is a member of IoPP. MDPTC Update ABSTRACT Within the IoPP, the institute of packaging professionals, a medical device packaging technical committee MDPTC, exists to help serve the medical device packaging industry. A brief committee update will be presented. My role is as the Task Group Chairperson. ABOUT THE SPEAKER Karen Greene, CPP, Vice President Sales and Technology, Life Packaging Technology LLC Ms. Greene is a tenured package engineering professional with 21 years of experience in the medical device and pharmaceutical packaging industries. The first 7 years of her 28 year career were in the food packaging industry where she held professional positions with Nabisco Brands and Thomas J. Lipton Company. Distribution Testing — What is the industry doing? ABSTRACT Distribution Simulation is a uniform way of evaluating shipping units through the use of laboratory equipment that subjects the packaging system to specific hazards that may occur within the anticipated distribution environment. Understanding the methodologies behind the processes is vital for medical device manufactures to get their product to market. This presentation will examine the most common methodologies being utilized by medical device manufacturers including ASTM and ISTA procedures. It will also expose the benefits and drawbacks of certain methodologies and offer valid solutions. The presentation will cover significant steps that need to be considered when designing your shipper for distribution simulation and review the problematic scenarios that may arise during the process. ABOUT THE SPEAKER Scott Levy, Packaging Engineer, Distribution Dynamics (DDL) Mr. Scott Levy has been the lead packaging sales engineer at DDL for the last twelve years. He is responsible for training and managing five other sales engineers throughout the United States. He takes responsibility to work one on one with clients to ensure their packaging project complies with industry standards and regulations the first time.
He specializes in ISO 11607 and also has an extensive background in shock and vibration testing that crosses all barriers in a vast number of industries. Panel Discussion — Simulated Distribution Testing. Lessons Learned from a Panel of Industry Experts ABOUT THE PANEL Scott Levy, Packaging Engineer, Distribution Dynamics (DDL) Mr. Scott Levy has been the lead packaging sales engineer at DDL for the last twelve years. He is responsible for training and managing five other sales engineers throughout the United States. He takes responsibility to work one on one with clients to ensure their packaging project complies with industry standards and regulations the first time. He specializes in ISO 11607 and also has an extensive background in shock and vibration testing that crosses all barriers in a vast number of industries. Michael L. Troedel, President Troedel & Associates, Inc Mike has over 35 years of experience in the high volume consumer foods, medical device and flexible packaging industries with such companies as Baxter Healthcare, General Mills, Kraft General Foods, Milprint and Pactiv Corporation. Since starting his own consulting business, he has worked with Cardinal Healthcare, Boston Scientific, Zimmer, Coors-Molson Brewing, Mocon and Gerber Products. Mike has served on a number of university advisory committees, the Board of Directors for the Packaging Education Foundation, the Consultants Council of the Institute of Packaging Professionals (IOPP) and has served six years as Chairman of ASTM Committee F-2 on Flexible Packaging. Mike received the 1996 Baxter Corporate Annual Outstanding Technical Contribution Award and the 1997 Baxter Distinguished Technical Achievement Award. In 2007, Mike received the ASTM Award of Merit, an honorary title of Fellow, for his long term service, leadership and technical contributions to Committee F-2 and the Flexible Packaging Industry. Jennifer Goff (Rees), Supervisor, Packaging Laboratory, Edwards LifeSciences Jennifer holds a B.S in Packaging from Michigan State University. Her past experience includes positions with Wyeth Consumer Healthcare and Edwards Lifesciences. Jennifer's responsibilities at Edwards Lifesciences have included: Operations/manufacturing support for equipment validations, cost saving initiatives and material changes. Jennifer manages the Packaging Laboratory for the Packaging Development and Packaging Operations group within Edwards Lifesciences. She is an active member on the ASTM D10 and F02 committees. Attended the international ASTM Committee Meeting last fall. Certified packaging professional (CPP) and a member of IoPP. Medical Device Packaging International Standards Update — A Review of Recent ASTM International Workshop and Other New Standards Activities ABSTRACT This presentation will cover recent ASTM International Standards activities including a brief overview of ASTM Committee F-2 and a recent International Workshop held in Prague, CZ.  ASTM International Overview Upcoming Revisions to ISO 11607 ASTM Seal Strength(F88) Test Method Revisions Case Study on Validation of Test Methods Upcoming Dye Penetration Test Method Improvements Climatic Stressing of Packaging Systems in the Distribution EnvironmentABOUT THE SPEAKER Michael L. Troedel, President Troedel & Associates, Inc Mike has over 35 years of experience in the high volume consumer foods, medical device and flexible packaging industries with such companies as Baxter Healthcare, General Mills, Kraft General Foods, Milprint and Pactiv Corporation. Since starting his own consulting business, he has worked with Cardinal Healthcare, Boston Scientific, Zimmer, Coors-Molson Brewing, Mocon and Gerber Products. Mike has served on a number of university advisory committees, the Board of Directors for the Packaging Education Foundation, the Consultants Council of the Institute of Packaging Professionals (IOPP) and has served six years as Chairman of ASTM Committee F-2 on Flexible Packaging. Mike received the 1996 Baxter Corporate Annual Outstanding Technical Contribution Award and the 1997 Baxter Distinguished Technical Achievement Award. In 2007, Mike received the ASTM Award of Merit, an honorary title of Fellow, for his long term service, leadership and technical contributions to Committee F-2 and the Flexible Packaging Industry. ISO11607 Update ABSTRACT Information to come. ABOUT THE SPEAKER Michael Scholla, Senior Consultant, Dupont Protection Technologies Dr. Michael H. Scholla is Director, Global Regulatory and Standards within DuPont Medical and Pharmaceutical Protection located in Wilmington, Delaware where he is a member of the medical packaging, medical fabrics and pharmaceutical protection businesses. Mike has a diverse research background with more than 60 publications and six patents to his credit. He is actively involved in several industry groups including: Treasurer and member of the Executive Committee of the Association for the Advancement of Medical Instrumentation (AAMI), member of the Sterilization Standards Board and Committee on Standards Strategy. Mike is also the Convener of ISO TC198 WG7 on Medical Packaging responsible for the harmonized standard ISO/EN 11607. Mike is a member of the editorial board for “Pharmaceutical and Medical Packaging News” and a thirty year member of the American Society for Microbiology. Prior to joining DuPont, he was a member of the faculty at the University of Memphis. Dr. Scholla was awarded the BS and MS degrees in Microbiology from the University of Central Florida and the Ph.D. from North Carolina State University. In 2006, Mike was awarded the Alumni Professional Achievement Award from the Burnett College of Biomedical Sciences at UCF. The Challenges of Implementing Biopolymer Packaging Materials in the Medical Device Industry ABSTRACT This presentation addresses the unique challenges of utilizing sustainable packaging materials in the Medical Device industry and also discuss initiatives that you can create in your organization to improve its environmental impact. Biopolymers 101 Medical Industry Challenges Opportunities for Biopolymers in the Future Other Opportunities for SustainabilityABOUT THE SPEAKER Don Krebs, CPP, Sr. Packaging Engineer, Edwards LifeSciences Don Krebs is Senior Packaging Engineer of Global Packaging Operations for Edwards Lifesciences in Irvine, CA. He specializes in manufacturing engineering for a variety of Edwards' medical technologies and is currently focused on the company's production of devices at its facility in the Dominican Republic. During Don's time at Edwards he has led and contributed to many "green" packaging initiatives in the Caribbean and is an active participant on Edwards' internal employee-volunteer environmental team, called "Project Green." General Effects of EO and Radiation Sterilization on Devices and Packaging ABSTRACT The effects of EO and Radiation on healthcare materials and components must be examined by the manufacturer. Previously AAMI TIR 17 (1997), Radiation Sterilization - Material Qualification, provided guidance on these effects, but only examined radiation sterilization. AAMI TIR 17 (2008) has been updated to provide guidance on the effects of EO and other sterilization methods on materials and components. The material constraints and other obstacles will be reviewed regarding EO and Radiation sterilization as they relate to healthcare products. Effects of Radiation on materials and components Effects of EO on materials and components Highlights of AAMI TIR 17 (2008)ABOUT THE SPEAKER Lisa Foster, V.P. SteriPro Services, Sterigenics Lisa Foster began her medical device career at Sterigenics International in 1989. Throughout her tenure, she has held Quality Assurance positions at the facility and the corporate levels. In 1997, Ms. Foster was named Vice President of Quality Assurance for Sterigenics, the world's leading supplier of sterilization and ionization services for the medical devices industry.
In 2004, she was promoted to her current position as Vice President of SteriPro® Services. This division of Sterigenics International includes two value-added service offerings, SteriPro Consulting and SteriPro Labs. The Importance of Seal Integrity and Verification for Sterile Medical Device Packaging ABSTRACT This presentation will cover:
Introduction: Medical Device Packaging ‘The basic challenges facing medical device manufacturers remain fairly constant while the complexity of the challenges increases constantly.’ This talk will highlight the current state of these constant issues and focus on the increased complexity associated with seal integrity. Issues Facing Sterile Medical Device Packagers What is Package Integrity? Focus on Seal Integrity Challenges Always important…why even more important now? Conclusion: An Example of a Potential Multi-Level SolutionABOUT THE SPEAKER Jane Severin, Director of Technology, Oliver-Tolas Healthcare Packaging Dr. Jane Severin is a Director of Technology at Oliver-Tolas Healthcare Packaging. She leads Oliver-Tolas’ team of technical experts and is responsible for the company’s technology strategy, product development and maintenance, and design control. She also oversees Oliver-Tolas’ technical compliance with regulatory standards, test method development and process validation. |
||||||||||
