Abstracts

Catalyzing Circularity: A Case Study in Adopting Certified Advanced Recycled Materials for Medical Packaging

As advanced recycling technologies continue to rise to commercial scale, medical device manufacturers have an opportunity to enable circularity by driving demand for recycled plastics with certified, sustainably-sourced materials that are indistinguishable from those used today. But how do we implement these materials into the packaging value chain? This case study will explore the first adoption of Eastman EastarTM Renew to produce sterile barrier packaging by allocating recycled plastic waste using an ISCC PLUS certified mass balance process. Prepare yourself for a unique, collaborative, and engaging presentation that will be entertaining, educational, and enlightening!

Unlocking the Potential of Advanced Recycling: Today’s Technology Landscape and Opportunities for Medical Packaging

Advanced recycling technologies offer an important piece to the circularity puzzle, complementing mechanical recycling by solving for the most difficult to recycle plastics and unlocking a source of sustainable feedstocks. By sourcing plastic waste as a feedstock, these technologies divert difficult-to-recycle plastics from landfills, leaving fossil resources in the ground, and potentially lowering greenhouse gas emissions, while allowing for the creation of plastics with recycled content that are chemically and physically identical to those made with virgin fossil feedstocks. Although these processes are not new, technology providers are applying them in innovative ways to address plastic waste and close the loop on plastic supply chains. Leveraging the potential of these technologies will require unprecedented value chain collaboration, flexible technology platforms that evolve over time, and enabling broader understanding of how these technologies apply to various plastic supply chains.

Join experts from the field as they discuss today’s advanced recycling technology landscape, the role these technologies can play in bridging the circularity gap, and how they apply to commonly used medical packaging materials.

Creating a Business Case for Advanced Recycled Materials:
Critical Questions from the MDM Perspective – A KiiP Collaboration

As circular materials powered by advancing recycling technologies enter the market, medical device packaging engineers seeking to integrate these sustainably-sourced materials face many questions from their stakeholders. To address these questions, the KiiP Sustainability and End-of-Life team is breaking down value chain silos from advanced recycling technology providers to medical device manufacturers, regulatory stakeholders, end users, and beyond. The mission: Develop and socialize foundational knowledge around advanced recycling, common frameworks and terminology, industry consensus on acceptance, and a business case for adopting certified circular materials for sterile packaging.

This crowd-sourced, engaging session will highlight critical questions raised from the MDM perspective, the journey to effectively satisfy these questions, and how the industry can collaborate to accelerate the path to circularity.

Sterile Packaging Recycling Pilots: A Journey to Circularity

Recycling can be difficult and recycling sterile barrier packaging comes along with even more challenges and barriers. Tackling this challenge head on, the DuPont™ Tyvek® Healthcare Packaging team leveraged learnings and relationships made through involvement in the Healthcare Plastics Recycling Council to help set up and execute healthcare plastics recycling pilot programs. We’ll take you through this journey from planning, education, implementation, and bumps along the way as we strived to collect and redirect healthcare plastics away from landfill and incineration to advanced recycling processes to help drive circularity.

End-of-Life Journey of Medical Packaging: What You Should Know as a Packaging Engineer

Historically, medical packaging and product systems were designed for a linear lifecycle while prioritizing safety, product performance, sterility, and profit without equally valuing the impact on people and the environment. As the medical industry moves to embrace a more sustainable, circular future, packaging engineers — who typically focus their efforts on the upstream journey and use of packaging by medical professionals within hospitals — must re-think the end-of-life journey for medical packaging and innovate in entirely new ways that can serve both patients and the environment.

Do you know where medical packaging waste goes? What is truly recyclable and what is actually being recycled today? How are recycling capabilities evolving globally and how does this impact the healthcare industry? Join this panel of experts as we answer these questions and more while examining the end-of-life journey for medical packaging.

Packaging Groundhog Day: How Do We Challenge the Status Quo?

As engineers in the medical industry, we face a great deal of barriers when bringing a product to market. The largest challenge we face is short timelines due to packaging being the last thought prior to launch. How can we be innovative as an industry while facing these challenges? During this presentation, we will walk through challenges the SDC has faced through implementation of new material combinations and the path to execution.

Can your Package “Take a Licking” and “Keep On Ticking”? How to Tackle Human Nature and Mother Nature with Robust Package Design

You’ve probably heard of Murphy’s Law, “Whatever can go wrong, will go wrong.” But how can you prevent Murphy from ruining your Medical Device Packaging? The answer is Robust Design! Come join Brian Farison for this engaging session where he will show how Robust Design principles can keep Murphy away and elevate your package performance to be World Class.

In this session you will learn:
· The case for Robust Design. What it is and what it’s not.
· The true costs of poor package performance.
· What “Worst Case” means and how it differs from “Armageddon.”
· The tale of two mindsets: Passing the Test vs Understanding the Design.
· How feasibility testing can save your design and your career!
· Discussion of failure modes (Material / Design / Process).
· Understanding Sources of Variation / Principles of Variation Transmission in design and testing.

Connected Combination Devices Elevate User Experience

Drug-delivery devices are in so many hands these days, as they help deliver convenience, compliance, and safe care — especially for chronic diseases. While the drug might be the star, the delivery device often determines the product’s success. As popularity of and demand for combination devices skyrocket, packaging innovations are vital to meet functional and marketing needs. Next-generation devices will leverage our “connected” society for various patient benefits, like information sharing to ensure compliance and intuitive administration. How likely will these emerging products succeed — considering human factors engineering issues, sustainability concerns, and ecommerce challenges?

In this Q&A presentation, veteran journalist Lisa Pierce elicits insights and advice from drug-delivery device expert Mathias Romacker. Now a consultant, Romacker has more than 30 years of experience in injectable drug-delivery devices at drug-device manufacturers Pfizer, Becton Dickinson (BD), and Amgen, and packaging supplier Gerresheimer.

Takeaways will include:

What smart “connected” packaging can add to a patient’s positive outcome;
Where human factors engineering shines;
Why sustainability influences initial device design as well as disposal;
How e-commerce shifts attention to secondary packaging and more effective Instructions for Use.

Wicked Stability: Project Progress and Workstream Updates

As this team continues on the journey of changing how our industry thinks about material stability, we are learning new ways to reveal and test for degradation. We’ll discuss these learnings as well as the addition of several new project workstreams focused on bringing in additional information to support our hypothesis. These include evaluation of Medical Packaging Transition Project data (one of the largest industry experiments ever conducted) and collaboration with multiple MDMs to learn how they might share sterile barrier material stability observations.

What is SBS Package Performance Testing 1, 2, 3 …

ISO 11607 requires performance testing for sterile barrier systems. Performance testing is often referred to in various ways: ship testing, transit testing, distribution testing, shake and bake (though the ‘baking’ has to do with aging). This talk will discuss applying the intricacies of ISO 11607 performance testing in the laboratory to simulate the distribution environment and successfully validate the packaging.

Comparing Impact of Distribution Hazards on Similar Packaging Systems – Adopting Bracketing Approaches to Meet Compliance

In our industry, it is challenging to incorporate even minor changes to product-package systems. It typically requires risk assessments, extensive testing, resource allocation from cross functional teams, and complex project management. What if, in certain scenarios, a bracketing approach could be adopted? A technical rationale could allow projects to proceed at accelerated timelines while continuing to maintain compliance. In this talk, we discuss a framework for establishing a rationale to leverage like-validation.

Using Damage Boundary Theory as a Tool for Sustainability

In this talk, we are going to expand beyond the sterile barrier system and look at larger capital medical equipment which requires a specifically engineered cushion design. We will explore the Damage Boundary method using the guidelines of ASTM D3332, which is used to characterize product fragility. When product fragility testing has been conducted, the cushion system can then be designed to optimize packaging. More specifically, when damage boundary is conducted, it eliminates both over and under packaging. When excess packaging is eliminated, it leads to waste reduction and an optimized supply chain. This methodology, which is universal to many industries and products, provides another tool in your sustainability toolbox.

Reducing Sealing Variability and Increasing Process Capability

Understanding the inputs and the impact to the corresponding outputs is essential to reducing variability and increasing capability within a sealing process. This session analyzes the major inputs to a sealing process, including equipment, materials, test methods, and human factors. The session will discuss how reducing the variability of these process inputs yields a high capability and ensures business success. The session will conclude by summarizing ongoing best practices to maintain capability post completion of validation activities.

Packaging – It’s More Than Meets The Eye: Putting the “Ability” Back in Usability

Is there more to Packaging than containment and protection? We all know the answer is “Yes.” A package needs to maintain sterility to the point of use and communicate critical information, then it needs to be opened so the product can be aseptically presented to the sterile field.

But is it more than that? What other customers of Packaging and the Packaging function are there within the sterility assurance value chain?

Join us to empathize and understand how there is more than meets the eye so that we can put the “Ability” back in Us-Ability!

Building a Plane While Flying is Not Easy – Learn How ASTM is Developing a Guide to Help the Industry Meet or Exceed Requirements of ISO 11607 Section 7

Practical usability assessments in medical packaging: just how good does your simulation really need to be? This interactive and engaging presentation covers a practical approach of using the ASTM Usability Guidance to meet the mandatory minimums and enhance the quality of usability studies with suggested best practices.

This panel of experts will describe usability assessments in a variety of use environments, including home healthcare, surgical, vascular, and ambulatory, to aid packaging engineers in executing effective usability assessments.

Human Factors Engineering: How to Incorporate Usability Principles and Practices to Packaging Design to Create Safe and Effective Product-Packaging Systems for Your Users

Is Packaging just a container? Learn how human factors engineering (HFE) and usability principles and practices can be applied to packaging design to satisfy user requirements beyond regulatory requirements.

Human Sustainability Through Connection and Vulnerability

Step into a new mindset with the panel as they break down intimidating barriers and common misconceptions in industry. This high energy Q&A will pull from panelist’s personal experiences and reveal the benefits of human sustainability through personal and professional development. Join the conversation, transform your thinking (or “find your voice”?), and dare to do mighty things.

Medical Packaging From the Patient’s Perspective

When I was 13 years old, I was diagnosed with a large cancerous brain tumor. I will be telling my story with emphasis on the packaging I experienced. While in the hospital, something that I did not like was how loud the packaging was, especially pouches being torn open. This tearing sound classically conditioned me to expect pain just like Pavlov conditioned his dogs to salivate when they heard a bell ring. Whenever I heard the sound of a pouch or tray being opened, I would tense up and become really anxious. This would actually cause the needle stick to hurt much more than if I had been relaxed. There was even a few times when I was woken up from a deep sleep by a pouch being opened. The goal of my presentation is to bring awareness about sound caused by medical packaging. I also wish to form a research team to find ways to make medical packaging quieter and I’m sure that there is someone that will be attending the[PACK]out that could help me.

ASTM F02 Primary Barrier Packaging Committee

Back by popular demand – the Industry Power Hour! Have you ever wanted to get ahead of major changes that are happening in our industry or get a better understanding of what’s to come with consensus on standard changes? Maybe you wanted to get involved to help address tough industry challenges that impact your day to day, but struggled to find everything available to you. The Industry Power Hour will be an action–packed session on the[PACK]out agenda with representatives from MDPTC, HPRC, KiiP, ASTM, and more! Each representative will have 10 minutes to give a brief overview of the organization, working items currently being addressed, and how to get involved. It will be fast-paced, engaging, and educational — leaving you informed and ready to take action.

HPRC (Healthcare Plastics Recycling Council)

Back by popular demand – the Industry Power Hour! Have you ever wanted to get ahead of major changes that are happening in our industry or get a better understanding of what’s to come with consensus on standard changes? Maybe you wanted to get involved to help address tough industry challenges that impact your day to day, but struggled to find everything available to you. The Industry Power Hour will be an action–packed session on the[PACK]out agenda with representatives from MDPTC, HPRC, KiiP, ASTM, and more! Each representative will have 10 minutes to give a brief overview of the organization, working items currently being addressed, and how to get involved. It will be fast-paced, engaging, and educational — leaving you informed and ready to take action.

IoPP MDPTC (Medical Device Packaging Technical Committee)

Back by popular demand – the Industry Power Hour! Have you ever wanted to get ahead of major changes that are happening in our industry or get a better understanding of what’s to come with consensus on standard changes? Maybe you wanted to get involved to help address tough industry challenges that impact your day to day, but struggled to find everything available to you. The Industry Power Hour will be an action–packed session on the[PACK]out agenda with representatives from MDPTC, HPRC, KiiP, ASTM, and more! Each representative will have 10 minutes to give a brief overview of the organization, working items currently being addressed, and how to get involved. It will be fast-paced, engaging, and educational — leaving you informed and ready to take action.

KiiP (Kilmer Innovations in Packaging)

Back by popular demand – the Industry Power Hour! Have you ever wanted to get ahead of major changes that are happening in our industry or get a better understanding of what’s to come with consensus on standard changes? Maybe you wanted to get involved to help address tough industry challenges that impact your day to day, but struggled to find everything available to you. The Industry Power Hour will be an action–packed session on the[PACK]out agenda with representatives from MDPTC, HPRC, KiiP, ASTM, and more! Each representative will have 10 minutes to give a brief overview of the organization, working items currently being addressed, and how to get involved. It will be fast-paced, engaging, and educational — leaving you informed and ready to take action.

SPMC (Sterilization Packaging Manufacturers Council)

Back by popular demand – the Industry Power Hour! Have you ever wanted to get ahead of major changes that are happening in our industry or get a better understanding of what’s to come with consensus on standard changes? Maybe you wanted to get involved to help address tough industry challenges that impact your day to day, but struggled to find everything available to you. The Industry Power Hour will be an action–packed session on the[PACK]out agenda with representatives from MDPTC, HPRC, KiiP, ASTM, and more! Each representative will have 10 minutes to give a brief overview of the organization, working items currently being addressed, and how to get involved. It will be fast-paced, engaging, and educational — leaving you informed and ready to take action.

Answering the FDA Ethylene Oxide (EtO) Sterilization Innovation Challenge

The Problem: According to the FDA, over 20 billion medical devices sold in the U.S. every year are sterilized with ethylene oxide (EtO), accounting for approximately 50% of the sterilization market. For many medical devices, ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process. Despite its efficacy, safety concerns have arisen over its use due to being a carcinogen and harmful to sterilization workers and nearby communities. For years, the FDA and EPA have challenged the medical device community to develop effective sterilization technologies that do not rely on ethylene oxide.

The Innovation: In an answer to this challenge, we have created a packaging system that directly sterilizes medical products with a safe and effective alternative to EtO while still providing the benefits of gas sterilization. The primary packaging material contains a polymer that stores and releases nitric oxide (NO) – the body’s natural antimicrobial/antiviral agent that is produced by nearly every cell in the human body. We will present evidence that demonstrates this technology is safe and effective against spore forming bacilli, Gram (+), Gram (-), and antibiotic resistant bacteria. NO does not damage devices and this material innovation is safe for those handling packaging during manufacturing and for end users removing devices from packaging. This system does not require special handling, aeration, or disposal because NO is non-toxic to mammalian cells and tissues. Simply place a medical device into a pouch, tray, etc. converted with this polymer, and the device will be sterilized by the packaging itself. This system is currently before the FDA.