DUPONT
DD]

Everyone would agree that a medical device packaging industry’s primary objectives are to design solutions for the most effective sterile barrier packaging. So, the professionals of the field always research and brainstorm about technologies and advanced materials, create a design, put it through rigorous testing, and upon passing tests, voila—a sterile barrier package is born. End of story for sterile barrier packaging, right?

Not so fast…

It is indeed true that the main goal of the sterile barrier package is to get the product to the end user in a sterile, usable, and sustainable manner. But, another, albeit important objective of sterile barrier packaging is to think about end-user perception and opinion of the packaging. It can get a bit tricky, but it is where one can tap into the hidden value packaging brings to a product.
End-user perceptions are developed through the first sight of the package. Consequently, opinions are formed through their use of the package. Between perception and opinion are assumptions and expectations. End users may be aware of some of their expectations, like for instance, assume the packaging meets required tests and it provides a sterile barrier to the device within. And then there can also be some expectations of which they are consciously unaware of, which aren’t realized until they are met or not fulfilled.

So how does a company unravel this Gordian Knot between usability and user perception of sterile medical device packaging?

DuPont Tyvek® medical and pharmaceutical packaging solutions are the answer. The perfect confluence of sustainable and well-designed packaging solutions, Tyvek has been a trusted choice for medical device and pharmaceutical manufacturers as well as specialized sterile packaging suppliers worldwide for decades.

What further backs Tyvek’s quality assurance in the medical device packaging and sterilization industry is its parent brand, DuPont [NYSE:DD], which needs no special mention when it comes to fostering innovation. For more than 200 years, DuPont’s name has been synonymous with life-changing discoveries and scientific know-how. The company’s wide-ranging community of scientists, engineers, visionaries, and partners works steadfastly every day to turn possibilities into real world answers that help humanity thrive and shape a better world. Under the leadership of Edward Breen, executive chairman and CEO of DuPont, the company has been constantly steering its value across industries, including healthcare, by unlocking the full potential of DuPont’s technological capabilities, innovative portfolio, and application expertise. Built on this heritage of scientific innovation and driven by collaborative spirit, DuPont Tyvek is proudly helping people live longer and healthier by advancing sustainability in healthcare packaging as an important extension of that role.

DuPont Tyvek is proudly helping people live longer and healthier by advancing sustainability in healthcare packaging an important extension of that role

Offering Unrivalled Aseptic Packaging Performance

Now, more than ever, medical device packaging and sterilization have turned into a dynamic market on account of the COVID-19 pandemic, changing healthcare demands, unstable supply chains, and tougher regulations. There is still a lot of change to contend with in the medical device manufacturing realm, but for now, Tyvek is focused on cautiously settling into the new normal when it comes to packing and sterilization of medical products.

To that end, Dan Floyd, microbiologist, and medical device and regulatory specialist for DuPont Tyvek medical and pharmaceutical packaging, notes, “Designing the product, as well as the packaging, with the mode of sterilization in mind will become even more in the future critical than it is today, considering the limitations of some of the alternate sterilization methods.” For example, he explains many gaseous methods do not penetrate nearly as well as ethylene oxide (EO). So, changes may need to be incorporated to the packaging to increase the breathable area and allow for more efficient sterilant penetration. “To make that happen, the product must be designed to ensure the sterilant can penetrate to all the hard-to-sterilize locations on the device.

Modifications to the device configuration or even materials of construction may be needed.”
Notably, Tyvek takes all these aspects under critical consideration to address the diverse range of medical and pharmaceutical packaging needs. The company, as a result, provides packaging solutions with the ultimate tear resistance, durability, breathability, clean peel, and superior microbial barrier to keep medical equipment and pharmaceuticals sterile throughout their lifecycle— protecting the health and well-being of millions without compromise. On top of that, Tyvek is also compatible with almost all the commonly used sterilization methods, including, EO, radiation (Gamma and electron beam), steam under controlled conditions, and low-temperature oxidative, making Tyvek’s solutions easy to include in any kind of medical packaging processes.

Packaging and Sterilization for Demanding Applications

Made of high-density polyethylene (HDPE), Tyvek offers exceptional protection against damage for sharp or heavy products, outperforming more fragile alternative materials, such as medical-grade paper. Even under the most rigorous conditions in highly contaminated environments, Tyvek 1059B is highly resistant to penetration by bacterial spores and other contaminating microorganisms.

Microbial barrier test data consistently prove that all styles of Tyvek for sterile medical packaging—Tyvek 1073B, Tyvek 1059B, and Tyvek 2FS—hold out bacterial spores and test particles better than other commercially available porous medical packaging materials, including medical-grade papers. While Tyvek 1059B provides robust protection for medium-risk, sterile medical packaging applications, Tyvek 1073B protects and maintains the sterility of high-risk medical products, from artificial hips to heart valves. Both these products have tough, continuous filaments that help protect package integrity from product breakthrough inside and rough handling outside. Compared to medical-grade papers, Tyvek 1059B and 1073B have superior tear strength and puncture resistance. In addition, a long-term shelf life study proves that Tyvek 1059B and 1073B can maintain sterility for at least five years if package integrity is not compromised.

Tyvek 2FS, on the other hand, is recognized as a standard of excellence for form-fill-seal and less demanding packaging applications. Another distinct advantage of Tyvek 2FS is its ability to endure the significant temperature and pressure changes commonly encountered during shipping. And since it is breathable, Tyvek 2FS can also easily minimize the formation of condensation due to temperature extremes, which can occur during transportation.

Proactive Collaboration toward a Circular Economy

As a leader in healthcare packaging, DuPont Tyvek also actively seeks ways to enable companies along the value chain to adopt recycling methods that divert healthcare packaging waste. And to make that happen, the company understands the need for better understanding of the barriers across the value chain. Thus, by leveraging its partnerships with advanced recyclers and industry organizations and collaborating with leading sterile packaging manufacturers (SPMs), medical device manufacturers (MDMs), and healthcare facilities, DuPont guides the entire value chain toward a circular economy as quickly as possible.

Driven by these competencies, DuPont Tyvek is quickly gaining worldwide presence and renown for its highest-grade packaging and sterilization solutions. Moving forward, the company will focus more on bolstering its role in raising awareness regarding the importance of a broad range of sustainable sterile medical packaging. Needless to say, through all these endeavors, DuPont will keep promoting safer medical products and help the people in need of these products.