Sterile Packaging: Start Sterile, Stay Sterile With Tyvek®
Tyvek® medical and pharmaceutical packaging provides durability, compatibility with a wide range of sterilization methods, and the highest microbial barrier of any breathable sterile packaging material.
DuPont™ Tyvek® medical and pharmaceutical packaging materials are an integral part of sterile packaging that helps protect drugs and medical devices—and the health of millions.
Tyvek® provides tear resistance, durability, breathability and superior microbial barrier to make sterile packaging which helps ensure medical devices that start sterile, stay sterile throughout their lifecycle.
Unlike medical-grade papers and films, Tyvek® is compatible with all of the most commonly used sterilization methods, including: ethylene oxide (EO), gamma, electron-beam, steam under controlled conditions and low temperature oxidative sterilization. The material science of Tyvek® enables sterilant gases and steam to penetrate and escape quickly.
Tyvek® has been a trusted choice for medical device and pharmaceutical manufacturers and specialized sterile packaging suppliers worldwide for decades. Because Tyvek® is produced according to ISO 14001, it can also be recycled, according to local regulations.
Tyvek® Medical Packaging Transition
The Tyvek® Medical Packaging Transition Project is a plan to transition Tyvek® 1073B and Tyvek® 1059B to the latest technology to help ensure greater continuity and flexibility of future supply. Global industry collaboration is making this possible.
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THE FACES OF DUPONT™ TYVEK®
Meet the Healthcare ExpertsMENU
Exceed healthcare standards through inclusive innovationCodes & Standards | Innovative Technologies | Package & Process Validation | Production Efficiency | Regulatory Compliance | Safety & Testing | Sterilization Compatibility
Roseann C. Salasin
Global Marketing Director
Packaging Engineer & MDM Specialist
Selena Qin, M.D.
Senior Technical Marketing Specialist
Jane E. Severin, Ph.D.
North America Regulatory Director
Packaging Engineer – Europe, Middle East, and Africa
Design with the future in mind.
New medical device technologies and growing global demand are expanding the need for effective sterile barrier systems. Building on its history as a leader, DuPont is working closely with sterile packaging manufacturers, device makers and regulatory bodies to understand future production, compliance and supply needs. How can DuPont help you solve your future challenges?
Michael H. Scholla, Ph.D - Global Regulatory Director
Dr. Michael H. Scholla engages global regulatory agencies responsible for setting sterile barrier system standards and helps medical device clients interpret these complex documents. With a Ph.D. in microbiology, Dr. Scholla is credited with six U.S. patents, chairs several healthcare advocacy groups, and has written over 60 white papers and articles.
Anticipating future supply needs.
DuPont is transitioning two key medical packaging materials: Tyvek® 1073B and Tyvek® 1059B, to manufacturing lines that use the latest flash-spinning technology. The Medical Packaging Transition Project is a global collaborative effort, intended to ensure greater continuity and flexibility of future supply to sterile packaging manufacturers, device makers and the healthcare industry.
Roseann C. Salasin - Global Marketing Director
As the global leader of DuPont’s Medical and Pharmaceutical Protection business, Roseann Salasin connects the science of DuPont to the industry, helping meet the needs of the value chain and improve patient outcomes.
Strengthen package integrity and product security.
Testing shows that DuPont™ Tyvek® provides superior puncture resistance and tear strength compared to medical-grade papers. The tough, continuous filaments of Tyvek® help maintain package integrity against sharp edges from within and rough handling from without. It's designed to support a high standard of protection, while providing “breathability” for valuable medical and pharmaceutical products.
Bruce A. Yost, Ph.D. - Global Technical Director
As Global Technical Director, Dr. Bruce A. Yost is chiefly responsible for helping to develop new applications. He partners closely with customers around the world to bring DuPont science to bear on the specific challenges facing healthcare packaging
Create packages that protect.
To successfully protect drugs and devices, there's a long list of criteria to meet, including compliance with regulations, ease of use, compatibility with sterilization methods, and efficient manufacturing. The DuPont™ Medical and Pharmaceutical Protection Team provides knowledge and tools to help you meet these critical criteria, along with global design and manufacturing support.
Karen Polkinghorne - Packaging Engineer & MDM Specialist
An expert in package design, equipment qualification, and package-and-process validation, Karen Polkinghorne works with manufactures to optimize their medical packaging. Her consultative approach provides options for package configurations and materialsto enhance sterilization, product security, and manufacturing efficiency.
Find working solutions for real-world issues.
The DuPont Medical and Pharmaceutical Protection Team includes regulatory affairs experts, technical specialists and packaging engineers. The Team works with medical device manufacturers and pharmaceutical companies to help develop a total solution, not just a packaging material.
Marc Bandman, Ph.D. - Market Application Development Manager
Dr. Marc Bandman provides technical support for the DuPont Medical & Pharmaceutical Packaging team. Drawing on his background developing specialty polymers, coatings, and films, Dr. Marc Bandman connects DuPont science to customer applications. He works closely with customers applying his knowledge to create innovative, cost-effective sterile barrier systems.
Source one material for a range of sterilization methods.
Sterilization is the unseen technology at the heart of much of medical packaging. Commonly used methods include ethylene oxide (EO), gamma, electron-beam, steam, and low-temperature oxidative sterilization. Unlike medical grade papers or non-porous packages made of film, DuPont™ Tyvek® is compatible with them all, and is specially engineered to enable sterilization gases and steam to penetrate and escape quickly.
Selena Qin, M.D. - Senior Technical Marketing Specialist
A practicing physician before joining DuPont, Dr. Selena Qin applies her professional perspective on the criticality of product sterility, helping to improve the quality of care for the growing patient population in Asia.
Help products that start sterile, stay sterile.
Superior microbial barrier packaging for sterilized medical instruments and devices helps keep contaminants out. From manufacturing to the operating room, the unique structure of DuPont™ Tyvek® helps block pathogens which might penetrate a package, threatening the sterility of a medical device and the health of patients.
Thierry Wagner - EMEA Regulatory Director
An expert on regulations and compliance standards for sterile barrier systems in Europe, and the Middle East, Thierry Wagner helps guide safety validation and testing protocols. He is a board member for the Sterile Barrier Association, and a member of ISO TC198 Committee, and CEN TC102 Committees.
Make infection prevention a patient and business priority.
Healthcare-Associated Infections (HAIs) result in billions of dollars a year in healthcare costs, and cause tens of thousands of deaths in the United States alone. The Patient Protection and Affordable Care Act of 2010 includes provisions that will penalize hospitals with the highest HAI rates. So improving sterile barrier systems to help reduce HAIs is both a patient care and business priority.
Jane E. Severin, Ph.D. - North America Regulatory Director
Dr. Jane E. Severin joined DuPont in 2013, bringing with her years of engineering and management experience. As a Certified Packaging Professional, Dr. Severin contributes to the development of medical packaging standards throughout North America, demonstrating how the science of microbial barrier technology can enable better healthcare outcomes.
Meet increasing standards with state-of-the-art compliance.
As the medical device market develops and expands in China, regulatory standards for packaging are developing as well. DuPont China was named as deputy leader of a new medical packaging working group, created to help device makers understand and meet current standards.
Park Qian - Standards & Regulatory Affairs Manager
Park Qian plays a pivotal role in new healthcare regulations for China. His experience and guidance to can help you adopt and adhere to China’s changing regulatory standards.
Print specialized packaging on standard equipment.
Pharmaceutical and medical packaging materials have unique printing requirements, such as 4 point Kanji characters. Tyvek® medical and pharmaceutical styles can meet these needs and be printed using standard commercial equipment. Our detailed printing guidelines are part of a broader focus on driving higher quality and efficiency in medical packaging applications.
Nicole Kaller - Packaging Engineer – Europe, Middle East, and Africa
Focused on technical and application support, Nicole Kaller provides a liaison between clients and DuPont product engineers, helping them identify relevant sterile packaging materials and technologies to support innovative, safe and cost-effective medical or pharmaceutical applications. Kaller frequently speaks at international conferences and seminars on the topic of packaging and technical studies for the healthcare industry.
Specify for compliance as well as performance.
Designing efficient, effective packaging requires specifying materials that meet regulatory standards. DuPont™ Tyvek® medical and pharmaceutical packaging styles comply with the materials portion of ISO 11607-1, as well as other regulatory requirements. We can help you meet compliance standards right from the start.
Ichiro Ikeda - Asian Regulatory Director
DuPont veteran, Ichiro Ikeda provides expert insight into a broad range of regulatory standards across the Asia-Pacific region. Over his career, Ikeda has worked on served on multiple standards developmental organizations and trade associations, including leader of Asia’s Sterilization Committee.
DuPont offers a broad range of healthcare products and high-performance materials that help create safer healthcare environments, contribute to innovations in medical devices and help protect the health of patients and healthcare providers worldwide.