Tuesday, October 21, 2008
9:00 AM - 4:00 PM (Lunch 12:00 PM - 1:00 PM)
| Session 102 - Medical Device Packaging |
Chair: Randall Troutman, Oliver Medical
Welcome and IoPP Medical Device Packaging Technical Committee Update: Randall Troutman
Part I - Materials Review and Applications
- Laboratory Practices for Optimal Thermal Gel Design and Specification: Karen Greene, DDL
- Tensile Testing Gerry Gunderson, Vice President, Engineering, Quality Tech Services, Inc.
- The Art and Science of Thermoforming: Jason Crosby, Plastic Ingenuity, Inc.
Part II– Real World Techniques and Applications
- GREENBOX – Re-usable Packaging:Eric Lindquist, Entropy Solutions Inc.
- Using and understanding statistical sample sizes for sterile barrier system validations: Nick Fotis, Cardinal Health
- Root Cause Package Failure Analysis: Lora Keena, Oliver Medical
- ASTM Standard: Karen Polkinghorne, North American Market Manager, Dupont Medical Packaging; Paul F. Herman, Application Consultant, DuPont Nonwovens
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Welcome and IoPP Medical Device Packaging Technical Committee Update
About the Chair
Randall Troutman, Technical Director, Oliver Medical
Randall Troutman, Certified Packaging Professional holds a B.S. from University of Wisconsin-Stout in Packaging and a MBA from Christian Brothers University in Memphis, TN. He has worked for Kimberly Clark, Medtronic, and Smith & Nephew. He is currently employed at Oliver Medical working in the Medical Engineering Department specializing in medical packaging material technologies. He is a member of the Institute of Packaging Professionals Medical Device Packaging Committee as well as the Association for the Advancement Medical Instrumentation packaging working group.
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Part I - Materials Review and Applications
Laboratory Practices for Optimal Thermal Gel Design and Specification
Abstract
This presentation will outline well reasoned and laboratory challenged practices for optimal thermal gel design and specification for the biotechnology and combination products market sector. The focus is the shipment of temperature sensitive products.
The presentation will provide laboratory studies which illustrate the thermal performance of critical design inputs for gel refrigerants. The presentation will educate the audience to the important design considerations when evaluating competing refrigerant designs and will provide you with information on how to set up laboratory studies which can more precisely demonstrate temperature controlled packaging performance in the field.
About the Instructor
Karen Greene, Technical Director, DDL
Ms. Greene is a tenured package engineering professional with 18 years of experience in the medical device and pharmaceutical packaging industries. The first 7 years of her 25 year career were in the food packaging industry where she held professional positions with Nabisco Brands and Thomas J. Lipton Company.
Her medical device and pharmaceutical packaging experience has included leadership positions with IMED Corporation(now Cardinal Health), Ohmeda Medical, Edwards Lifesciences and Allergan. She has led teams of individuals responsible for medical device and pharmaceutical package development, validation and production implementation and solved many tough problems related to sterile barrier package integrity, package design, test method development and quality related issues. Ms. Greene has worked extensively with off-shore manufacturing operations, facilitating packaging operations transfers and the establishment of packaging lines. She has also led teams responsible for documentation, configuration management and label development and control.
Ms. Greene is currently the Technical Director for DDL West, a package and product testing services provider. She is the Vice President of the southern California Chapter of the Institute of Packaging Professionals, a certified packaging professional(CPP) and an active member of the IoPP Medical Device Task Force Group. Ms. Greene is a member of the ASTM F02, Flexible Barrier Packaging committee. She is a graduate of Holy Cross College, Worcester, MA and holds a professional certificate in engineering management from the Univ. of California, San Diego.
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Tensile Testing
Abstract
To be updated shortly
About the Instructor
Gerry Gunderson, Vice President, Engineering, Quality Tech Services, Inc.
erry Gunderson is a Partner and Vice President of Engineering for Quality Tech Services (QTS), located in Edina MN, provides contract design, packaging and assembly services to the medical device industry. His experience in the packaging industry spans 21 years, with positions at Pillsbury, Medtronic, Pfizer and seven years as a Principal at G2 Design, Inc., a contract medical package design firm. Gerry holds B.S. degrees in Computer Engineering and Business Management, both from the University of Minnesota. He is a member of the Education and Labeling Task Groups for the IOPP Medical Device Technical Committee.
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The Art and Science of Thermoforming
Abstract
This thermoforming case study follows a medical packaging project through its development cycle. The unique perspective of this presentation will be the analysis of how art and science interact during product development and thermoforming, ultimately resulting in a flawlessly executed thermoformed product. Complicating all projects are the constraints assigned by the MDM, typically these constraints can create road blocks for execution. This case study will explore these constraints and ultimately the impact on the outcome of the project.
About the Instructor
Jason Crosby, Medical Business Manager, Plastic Ingenuity, Inc.
Jason Crosby is the Medical Business Manager for Plastic Ingenuity, Inc., located in Cross Plains, Wisconsin. Plastic Ingenuity, a custom thermoforming manufacturer, has formed its reputation in the industry by providing innovative packaging solutions, being customer focused and flexible. Mr. Crosby is responsible for all facets of Plastic Ingenuity''''s medical packaging business; dealing daily with operations, business development, package engineering and validation issues. He has a bachelor''''s degree from the University of Wisconsin-Whitewater and an MBA from the University of Wisconsin. He has 10 years of thermoforming industry experience with Plastic Ingenuity. He is a member of the Society of Plastic Engineers and Institute of Packaging Professionals. Additionally, Mr. Crosby has presented nationally on various topics related to medical packaging and thermoforming.
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Part II– Real World Techniques and Applications
GREENBOX – Re-usable Packaging
Abstract
To be updated shortly
About the Instructor
Eric Lindquist, Entropy Solutions Inc.
As President of Entropy Solutions Inc., Eric Lindquist oversees the company''s overall strategic direction, leads the development of major business partnerships and manages the company''s day-to-day business operations. Under Eric''s leadership, Entropy Solutions launched GREENBOX, the company''s patented thermal management packaging system in December 2007. GREENBOX is currently being used by some of the largest pharmaceutical and biological product manufacturers in the world.
Prior to joining Entropy, Eric served as Vice President and General Manager of a division of Contech Inc., General Manager for Polaris Snowmobile Division, Director of Sales, Americas Region for Nike Inc., and General Manager of Africa/Middle East for Wilson Sporting Goods Company.
Eric holds a Bachelor of Science from the Kelley School of Business at Indiana University, and completed graduate work at the St. Gallen School of Business in St. Gallen, Switzerland.
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Using and understanding statistical sample sizes for sterile barrier system validations
Abstract
Proper selection of sample sizes for sterile package validation is a critical decision that the packaging engineer is often asked to make. If too few samples are selected a wrong conclusion can be reached and a false sense of security will be generated. Too many samples to be tested is just a waste of time, energy and resources. A rational approach to this problem is to utilize statistical software tools to create a balanced experimental design. This talk will provide a foundational understanding of the terms and concepts associated with sample size selection. After a fundamental understanding is obtained, an approach utilizing a software package will be briefly demonstrated.
About the Instructor
Nick Fotis, Director, Cardinal Health
Currently the Director of the Packaging Technology Center at Cardinal Health’s Clinical and Medical Products segment, Nick spent 10 years with Baxter Healthcare in positions of increasing responsibility within their Corporate Packaging and later I.V. Systems packaging groups. From 1995-97 Nick was the Engineering Manager at Rexam Medical Packaging (later Amcor) in Mundelein, IL and then R&D Director for RMP before joining Cardinal Health.. Nick also taught undergraduate Package Engineering courses at the University of Wisconsin-Stout and is a member of the Institute of Packaging Professionals, AAMI and ASTM. Nick holds a Bachelor's and Master's degree in Packaging from Michigan State University. Nick is currently a Co Chair of the US Delegation to ISO TC198/WG7.
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Root Cause Package Failure Analysis
Abstract
A brief discussion on general problem solving methods for determining Root Cause Package Failures followed by three (3) case studies surrounding common, yet critical, package failures.
About the Instructor
Lora Keena, Director of Quality / Regulatory, Oliver Medical
Lora Keena is Oliver Medical's director of QA/RA and is responsible for FDA and ISO registration, inspection, and compliance for US and European facilities. Lora's areas of expertise include international auditing; quality systems; and suppliers, product, and process validation.
She has extensive experience and proficiency in FDA cGMP, QSR, MDD, FDA and ISO 13485 registration and inspections, 510(k) pre-market notification, international medical device registrations, supplier management and related regulatory affairs.
Lora was previously president of Regulatory Consulting Services; director of QA/RA at Inrad, Inc.; and director of QA/RA at LMI Medical.
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ASTM Standard
Abstract
DuPont colleagues Paul Herman and Karen Polkinghorne present information on the newest ASTM test method for medical packaging, ASTM F2638-07 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier. Topics covered include: the basics of filtration methodology, insight into the evolution of microbial barrier test methods, examples and interpretation of data generated by ASTM F2638 and, most importantly, the relevance of this test method to medical packaging engineers.
About the Instructors
Karen Polkinghorne, North American Market Manager, Dupont Medical Packaging
Karen Polkinghorne is currently the North American Market Manager for DuPont® Medical Packaging. During her career in the medical packaging industry, she has also worked as a packaging development engineer for an orthopedic implant company, quality manager for an entrepreneurial medical packaging converter and as a business development manager for a major sterile packaging manufacturer. Karen has specialized in medical package design, equipment qualification, package and process validation, and medical packaging sales and marketing. She is a member of the Institute of Packaging Professionals Medical Device Packaging Committee and holds a BS degree in Packaging from Michigan State University and an MBA from the University of Colorado.
Paul F. Herman, Application Consultant, DuPont Nonwovens
Paul F. Herman is presently an Application Consultant for DuPont Non Woven (NOW) businesses as well as a Technical Representative for DuPont’s Active, Industrial, and Medical packaging business segments.
During his twenty plus years of DuPont service he has been assigned to various roles within Central Research and Development (CR&D) and Advanced Fiber Systems (AFS). While assigned to AFS he managed a state of the art electrical testing facility for the Nomex® electrical applications research group.
Herman studied electrical engineering at Delaware Technical and Community College and the University of Delaware. Prior to joining DuPont in 1986 he performed technical service work for Bell & Howell and Flight Safety International. He was also employed as an engineer by Optical Crosslinks (OXL) where he developed prototypes for their fiber optics connector products and managed OXL’s small lot manufacturing group.
