Global Technical and Regulatory Experts for Tyvek® Medical & Pharmaceutical Packaging

 
 
 

Localized experts for knowledgeable support

You can count on DuPont™ to ensure product protection and sterility with proven materials and help from industry experts.

Specifically, DuPont™ packaging engineers, microbiologists and regulatory affairs experts are available globally to share their knowledge and support you with information about:

  • Materials

  • Packaging design and processing

  • First time device launches

  • Meeting worldwide regulatory and packaging standards

  • Our global network of packaging converters

All to enhance the confidence of your product regulatory submissions.

Our list of experts is sorted by region, but their knowledge can be leveraged globally. Please contact us for any specific questions or if you are interested in speaking with a specific expert. 

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Americas Experts

 
 
 

Jose Arevalo
MDM Specialist

Jose earned his bachelor’s and master’s degrees in Packaging. Prior to joining DuPont™, Jose held various technical and marketing management positions for global leaders in the packaging, healthcare and pharmaceutical industries. When he joined DuPont™ in 2005, he started as an SPM specialist to leverage his previous experience. During his 15-year tenure, he has worked globally to develop the medical packaging competence of individuals and corporations at all levels of the medical device market. He is a subject matter expert in Tyvek® and in most aspects of the packaging of medical devices.

 

Jennifer Benolken, CPPL
MDM & Regulatory Specialist

Jennifer earned her undergraduate degree in Manufacturing Systems Engineering and her master’s degree in International Management. Jen has worked in the medical device community since 1991 in a variety of packaging roles – packaging, labeling, and sterilization engineer in operations and R&D, flexible packaging sales representative, and manager of packaging engineering and labeling groups. She is currently the sub-committee chairperson for ASTM F02.50, Package Design and Development, as well as co-chair for AAMI’s ST/WG 7, Packaging Working Group. Jen is an active member of the Institute of Packaging Professionals (IoPP) where she attained her lifetime Certified Packaging Professional (CPPL) certification. She is also on the Board of Directors and is Vice Chair on its Medical Device Packaging Technical Committee (MDPTC). Jennifer is the editor for the upcoming 3rd edition of the Medical Device Packaging Handbook. She works with downstream customers at medical device and pharmaceutical organizations, providing education and answering questions about Tyvek® packaging and sterilization using her wide range of knowledge.

 

Dan Floyd
MDM & Regulatory Specialist

Dan is a registered microbiologist with the National Registry of Certified Microbiologist, American Society of Microbiology and AAMI Certified Industrial Sterilization Specialist (CISS-EO) with over 28 years’ experience in medical device testing, sterilization sciences, packaging, industry regulations, and consulting. He has also been a certified quality auditor with the American Society for Quality. Dan has validated sterilizers on-site or assisted in sterilization consulting and training in the U.S., Canada, China, Malaysia, Singapore, Thailand, Brazil, Dominican Republic, Costa Rica, Puerto Rico, and Israel to name a few. Dan is a member of ISO/TC198/WG 16, ASTM F02, and AAMI working groups including industrial ethylene oxide sterilization, biological indicators, assurance of sterility, microbiological methods, process challenge devices, sterilization residuals, and resistometers. He is currently serving as co-chair for AAMI ST/WG 16 vaporized hydrogen peroxide sterilization. His specialties include EO, radiation, dry heat, steam, VHP, ozone, and liquid chemical sterilization testing as well as microbiology testing requirements of medical devices.

 

Nick Packet
MDM Specialist

Nick brings a versed skill set and insights to the DuPont™ Tyvek® Medical & Pharmaceutical Packaging team with 15 years in the medical device packaging space. He has led the design and qualification of complex sterile packaging systems and processes. Joining the Tyvek® team in 2017, he shares his technical knowledge, experiences, and problem-solving skills in his engagement with manufacturers and Tyvek® converters. Through this collaborative support, he has been able to identify opportunities where packaging can improve its performance, lifecycle impacts and overall cost of products. As a member of the Healthcare Plastics Recycling Council (HPRC), Nick supported the Flexible Packaging Recycling Study and is currently leading HPRC’s Advance Recycling project team as he has a passion for sustainability. With medical device and pharmaceutical companies facing a variety of challenges, he strives to educate and explore with manufacturers where and how packaging can go beyond normal expectations fostering a thought process that packaging should be viewed at each point or step within the product’s lifecycle. This process may be the key to solving some of the most challenging issues facing the companies and the industry.

 

Mark Sundt
Application Development Engineer

Mark graduated with a Materials Science degree from the University of Minnesota and joined DuPont™ in 2002. Mark transitioned to the Tyvek® business in 2012 and he has been involved with several global projects that include the Tyvek® Medical Packaging Transition Project (MPTP) and the development and launch of Tyvek® 40L. He enjoys providing technical and applications development support to both Tyvek® internal and external customers. He is also an active participant in ASTM Committee F02 on Primary Barrier Packaging.

 
 
 
 
 
 
 
 
 

EMEA Experts

 
 
 

Nicole Kaller
Application Development Leader

Nicole graduated with a Packaging Technology degree and has worked for DuPont™ Medical & Pharmaceutical Packaging since 2008. She is currently responsible for new application development in Europe and contributes to related global projects and quality benchmarking. In addition, she provides technical and application guidance to sterile packaging, medical device, and pharmaceutical manufacturers. She is regularly writing technical white papers and contributing to DuPont™ medical packaging knowledge sharing with expertise in packaging design, solutions, and testing; process validation; and application guidance. 

 

Thierry Wagner
Global Director of Regulatory & Standards

Thierry Wagner has spent over 30 years working for DuPont in its polyester films and nonwovens businesses and is currently the Global Director, Regulatory & Standards – Healthcare, DuPont – Safety & Construction. He is convenor of ISO/TC 198/WG7 “Sterilization of Health Care Products—Packaging” and CEN/ TC 102/WG4 “Sterilizers and associated equipment for processing of medical devices – Packaging”, chairman of the Sterile Barrier Association (SBA), member of the Parenteral Drug Association (PDA) and actively involved in various ISO and CEN technical committees on medical and pharmaceutical packaging, sterilization and aseptic processing. Thierry is also a member of ISO/TC 210 in charge of ISO 13485 and medical device symbols (ISO 15223 series), ASTM Committee F02 and of the CEN Advisory Board for Healthcare Standards - Europe (CEN ABHS). He earned a master's degree in mechanical and process engineering from ETH Zürich in Switzerland.  He is a featured speaker at international conferences and seminars on medical and pharmaceutical packaging regulatory aspects.

 

Bart Zeedzen
MDM Specialist

Bart has a proven track record within the medical packaging industry and experience with MDM’s and pharmaceutical companies. He started his packaging career in 2008 at Oliver Healthcare Packaging and was commercially responsible for the DACH and Nordic regions. Later, responsibilities were added to include the UK and Benelux. In 2018, he started at DuPont™ as an MDM Specialist for the EMEA region. He can provide high level commercial, technical and regulatory support with expertise in the areas of converting, coating, and life cycle value.  

 
 
 
 
 
 
 
 
 

AP Experts

 
 
 

Boon See Eng
AP SPM & MDM Specialist

Eng started his medical packaging career in 2009 at SteriPack Medical Packaging and was commercially responsible for ASEAN market. He joined Dupont™ in 2018 as an MDM specialist to leverage his medical packaging knowledge and experience formerly. In 2019, he became responsible for both MDMs and SPMs in ASEAN. He has a good relationship with all of the value chain partners in ASEAN for medical packaging. He can provide his expertise in most aspects of the packaging of medical devices.   

 

Rin Kawano
Japan Regulatory & Standards Specialist

Rin earned her master’s degree in applied polymer engineering. She has over a decade of technical experience in DuPont™ with polyvinyl fluoride film and perfluoroelastomer parts businesses in the electronics industry in a variety of assignments ranging from process development to application development to manufacturing and quality management. She currently serves as regulatory and standard specialist for DuPont™ Medical & Pharmaceutical Packaging in Japan. She is a member of the Japanese mirror group of ISO/TC 198 “Sterilization of Health Care Products”. She conducts seminars on Tyvek® as well as Medical & Pharmaceutical Packaging regulatory aspects in Japan.

 

Kaori Nakamura
Japan Segment Leader

Kaori is one of the leading experts in Tyvek® in the Japanese market. She has an extensive background in the regulatory arena and more recently has become a subject matter expert in Tyvek®. She leads the medical packaging team in Japan and understands the medical device market in Japan as well as the greater Asia market. She has been involved in the development and launch of 40L, customer adoption of all Tyvek® styles, and in advising on the optimal use in the medical device market. Her abilities to provide regulatory, technical, and marketing knowledge make her the person to know in Japan. She is a member of the Japanese mirror group of ISO TC/198 “Sterilization of Health Care Products” and the convener of ISO TC198/WG7 “Sterilization of Health Care Products—Packaging” in Japan since 2015. 

 

Darren Oh
AP SPM & MDM Specialist

Darren has worked in the chemical industry for over a decade. After joining DuPont™, he has worked in various sales roles for a variety of segments, including medical device and pharmaceutical packaging, active packaging, graphic and printing as well as the safety solution business including personal protective garments. He also has worked in a business development role for pharmaceutical applications. He is a member of the Korean mirror group of ISO TC/198 “Sterilization of Health Care Products” and conducts several seminars and workshops annually. 

 

Park Qian
China Regulatory & Standards Leader

Park earned his bachelor’s in Textile Engineering and his master's degree in Textile Material Science. He has 25 years working experience in DuPont™ nonwovens businesses, medical accessary, and medical packaging. He is a member of the Chinese Society of Biomaterials, member of SAC TC106 “National Technical Committee for standardization of medical infusion equipment”, SAC TC200 “National Technical Committee for standardization of sterilization technology and equipment”, China Medical Materials and Dressings Technical Committee, Medical Packaging Committee and High Molecular sub-Association of CAMDI (Chinese Association for Medical Device Industry). He has been involved in local medical packaging standard set up and promotion in Chinese medical packaging industry. 

 

Selena Qin, MD
China Regulatory and Standards and Hospital Outreach Leader

Selena joined DuPont™ in 2011 with over 25 years of experience in the medical industry. She received her M.D. degree in 1995 and practiced medicine as a radiologist and a surgeon for seven years. She also got her MBA degree in 2002. She has worked for two global medical device companies, Tyco Healthcare and GE Healthcare in product and business management for 10 years. Now she is responsible for driving regulatory and standard development for DuPont™ Medical & Pharmaceutical Packaging in China. She also serves as General Secretary of China Medical Devices Packaging Committee under China Association of Medical Device Industry (CAMDI) since 2016.

 

Billy Su
China Pharmaceutical Specialist

Billy has over 8 years of experience in DuPont™ with multi-functional roles across different industries. He has spent 5 years in Tyvek®, currently focusing on business development for pharmaceutical and medical device packaging. By deep-diving into the pharmaceutical industry, he has developed a wide network of customers and suppliers as well as in-depth experience with innovative solutions for the pharmaceutical industry.

 

Vishnu Vyas
AP Regulatory & Standards Leader

Vishnu Vyas has spent over 15 years working in Medical Device Industry in Regulatory, Standards and public policy function in a variety of assignments ranging from country regulatory affairs head to AP regional regulatory affairs. He joined DuPont™ in 2017 as Regulatory & Standards Leader for India/ ASEAN for DuPont™ Medical & Pharmaceutical Packaging business. Vishnu is packaging expert nominee to ISO TC198/WG7 “Sterilization of Health Care Products—Packaging” (ISO 11607) representing India. He has been an active member of RA committees of Medical Devices Industry associations like AMMI, Malaysia; MTaI, FICCI, AMCHAM in India. He is a featured speaker at regional and international conferences and seminars on medical and pharmaceutical packaging regulatory aspects.

 

Hanson Zhang
China MDM Specialist

Hanson has more than 15 years’ experience in the chemical industry with LG Chem, BASF, INEOS and DuPont™. In his previous role before joining DuPont™, he was the healthcare and diagnostic industry leader for medical plastics. He is currently responsible for business development for MDMs with a focus on comprehensive medical packaging solutions. He has rich market intelligence and technical experience from medical copolymer to packaging.

 

Lynn Zhang
China MDM Specialist

Lynn has over 15 years’ experience in the industry in various roles that includes on-site inspections & quality assurance consulting for a global pharmaceutical consulting company as well as working in a third notified body as a sales manager focusing on medical device testing in the life science department. She joined Dupont™ in 2017 as an MDM specialist for key account management and is currently serving as MDM business development manager for DuPont™ Medical & Pharmaceutical Packaging. She can provide her expertise in quality assurance, inspection, and testing.

 

Yunxia Zhang, PhD
AP Application Development Specialist

Yunxia earned her PhD degree in environmental chemistry and was a visiting scholar in Chemistry at University of Illinois at Urbana-Champaign from 2008 through 2010. She has over 9 years of technical working experience in aseptic pharmaceutical production and medical device and medical packaging. Yunxia currently serves as AP Application Development Specialist for DuPont™ Tyvek® Medical & Pharmaceutical Packaging. Her focus is to provide technical and applications development support for packaging solutions, application guidance, and related testing guidance for the medical device and pharmaceutical industry.

 

Nancy Zhu
China Application Development Specialist

Nancy earned her master’s degree in Polymer Materials. She has over 16 years of technical experience in global material companies in Lyondellbasell and BASF with in-depth technical expertise on packaging knowledge including package design, film configuration and process and package converting. She joined DuPont™ in 2014 and currently serves as an application development specialist for DuPont™ Medical & Pharmaceutical Packaging. She is responsible for application development and technical support of Tyvek® in medical device packaging. Her focus is in packaging material selection and study, package design, and applications.