Balancing Safety and Sustainability in DDC Product Packaging

As the world increasingly embraces environmentally responsible practices, pharmaceutical companies are under pressure to drive change across their supply chain.

While sustainable features are more easily adopted by oral solid dose formulations, applying the same principles to medicines for Drug Device Combination Products (DDCPs) has been a challenge due to strict safety and regulatory standards. Choosing a CDMO partner who can offer advice in container closure selection and provide sustainable solutions and design support for DDCPs can help pharmaceutical companies meet their environmental goals, without compromising on speed to market. The sustainability of DDCP packaging should be considered in the early stages of the product lifecycle during human factor studies and package design and development.

Understanding Sustainable Packaging Challenges for DDCPs

Pharmaceutical companies encounter several unique challenges when implementing sustainable packaging for injection devices, given the sector’s stringent regulations, patient safety concerns, and the nature of drug device combination products.

Regulatory Compliance and Safety Standards

Packaging for injection devices must meet rigorous regulatory standards for safety and efficacy, and maintain the sterility to prevent contamination. These standards require high-barrier materials that can protect against moisture, oxygen, and light. Sustainable alternatives, such as biodegradable or recyclable plastics, may not provide the necessary barrier properties or they may interact with the drug product itself, risking degradation, chemical leaching, or reduced efficacy.

Patient Centricity: Ease of Use and Disposal

As the self-injections market is projected to reach USD 97.36 billion by 20311, patient-centricity is of utmost importance as pharma companies aim to improve the user experience. Biodegradable plastics or paper-based alternatives may feel different in the hand than traditional plastics. This is important to consider for patients with reduced dexterity, arthritis, or other motor challenges if the device lacks sufficient grip. Another challenge we face when it comes to the end-user is the perception of lightweight sustainable materials as less durable or effective, which could affect their confidence in using the device.

Achieving Sustainability Goals with DDCPs

Selecting a device that aligns with your goals

The global rise in self-administered injections, with 16 billion injections worldwide annually for chronic diseases like diabetes, has led to a surge in disposable medical products2. Manufacturers face the challenge of creating eco-friendly solutions while maintaining product safety and effectiveness. Ypsomed is a company that recognized its responsibility and took action to reduce their environmental impact. In an effort to achieve net-zero carbon emissions across the company’s entire value chain by 2040, they introduced YpsoMate in NetZero Program, a prefilled autoinjector designed to emit fewer greenhouse gas emissions. By calculating a Life Cycle Assessment, a method for determining the environmental impact of a product, the hotspots of a conventional Ypsomed device were analyzed. In this initial step, Ypsomed has prioritized the most effective levers that can be implemented immediately to deliver early improvements. Already now, bio-based materials certified under the ISCC+ standard using the mass balance approach and optimized packaging are available. These innovations lower the carbon footprint of medical devices without affecting their quality or functionality.

This pioneering effort with YpsoMate in NetZero Program is just the beginning. Ypsomed has expanded its approach with the Ecodesign Guideline, providing clear strategies to embed sustainability into all aspects of product development. These principles shape not only the YpsoMate platform but also any new innovation project ensuring that Ypsomed’s next generation self-injection devices are designed to minimize their environmental impact and advance sustainability across the industry.

As sustainability becomes an increasingly important part of everyday life, it is crucial to be able to offer an environmentally friendly device as a more sustainable option for the end user.

The Impact of Lifecycle Assessments

The nature of DDCP’s make the development of sustainable solutions both challenging and rewarding. In the pharmaceutical industry, drug delivery devices and packaging are crucial areas that significantly impact environmental sustainability. By assessing the lifecycle of the product in its entirety from the materials of device components and packaging to distribution to the end-user, companies can identify key areas of improvement that will have the greatest impact. According to Victor Gherdan, Associate Director of Package Design at PCI Pharma Services, “The ultimate goal is to champion sustainable packaging initiatives for injection devices by helping clients discover, evaluate, test, and ultimately launch new eco-friendly packaging solutions.”

The ability to conduct comprehensive Life Cycle Assessments (LCA) and sustainability analyses is essential in providing data-driven insights that benefit both companies and the environment. Many pharmaceutical companies have made ambitious commitments to become carbon neutral by 2050, or sooner. By utilizing these advanced tools and processes, companies can leverage the data to make informed business decisions that will not only help them meet, but possibly exceed, their carbon neutrality goals.

Gherdan elaborates, “Recyclable, paper-based secondary packaging solutions for injection devices can provide the necessary functional performance while meeting high-quality standards and delivering a positive end-user experience.”

Reducing Environmental Footprint

In addition to paper-based solutions, it can be possible to optimize rigid and flexible packaging formats. For instance, thermoplastic trays, which are traditionally used for protective packaging for DDCPs, can often be resized, downgauged, or formed using more eco-friendly materials. LCA reports have also shown that shifting from a plastic tray to a molded paper fiber tray can maintain strength and durability, but at the same time, reduce its global warming impact by 50%. Even when sterilization or specific user needs still require the use of thermoplastic trays, more sustainable alternatives can be sought.

Balancing sustainability with commercial needs is one of the most pressing challenges facing the industry today. Companies must find ways to implement sustainable practices without compromising on cost-effectiveness or speed to market. “Our clients are faced with having to weigh these decisions often, and our role is to provide them with viable solutions for rapid and cost-effective implementation while offering them insights and data to help drive their selection,” Gherdan said.

An illustrative example of this balance can be seen in the recent optimization of a secondary packaging solution, where the size reduction and reconfiguration led to a 30% reduction in the overall packaging size. This change not only improved the sustainability of the packaging but also enhanced the efficiency of shipping and pallet design, resulting in lower storage and distribution costs particularly for cold chain products. By quantifying the environmental benefits – such as saving over 228,000 gallons of water or 1,825 liters of gasoline each year – companies can make informed decisions that align with their sustainability goals.

When to start

Integrating lifecycle assessments into the development process with human factor studies to ensure patient compliance and product performance is the most efficient way to integrate sustainability into your packaging. This can help identify potential issues with regards to sustainable materials selection and guide necessary design modifications. Human factors and usability engineering are integral components of regulatory submissions, essential for demonstrating the product’s usability and ensuring user comprehension.

Indeed, the successful integration of a drug and delivery device requires meticulous design control elements to address the unique challenges of combination products. Bill Welch, Executive Director Market Development at PCI explains, “Compatibility between the drug product, drug container and the device, as well as the potential impact on the product’s stability and performance, must be thoroughly assessed during the development phase.” Thorough testing of sustainable materials under various storage and usage conditions helps to confirm that the materials perform well and protect the product over its shelf life.

Additionally, establishing a robust risk management plan is critical for identifying and mitigating potential issues that may arise during product development. Such a plan should address not only traditional concerns related to drug stability, device functionality, and adverse component interactions but also sustainability-specific factors, like the recyclability of materials, potential for contamination in reusable parts, and environmental impact of disposal.

Whether managed internally by pharmaceutical companies or through Contract Development and Manufacturing Organizations (CDMOs), it is imperative for multi-disciplinary teams to collaborate, aligning on goals for sustainability, compatibility, and performance. This cross-functional approach ensures that sustainable design is integrated across drug product development, packaging design, and the supply chain, maximizing environmental benefits without compromising product safety, efficacy, or user experience.

Conclusion

As the pharmaceutical industry continues its journey toward sustainability, responsible packaging for drug-device combination products (DDCPs) will continue to evolve as new innovations are introduced. While the industry faces unique challenges due to strict regulatory requirements, patient safety, and the complexity of combination products, these obstacles also open up opportunities to innovate in ways that reduce environmental impact while maintaining product quality and functionality. By integrating lifecycle assessments, human factors, and comprehensive risk management early in the development process, pharmaceutical companies can create packaging solutions that meet both regulatory standards and sustainability goals.

Collaboration across multi-disciplinary teams and partnerships with experienced Contract Development and Manufacturing Organizations (CDMOs) will be crucial for optimizing packaging design and ensuring alignment with commercial objectives. Sustainable packaging for DDCPs not only fulfills environmental responsibilities but also addresses patient-centric needs by improving usability, reducing waste, and supporting companies in meeting ambitious carbon neutrality targets. Through these efforts, the industry is well-positioned to drive meaningful change and contribute to a greener future, without compromising on product safety, effectiveness, or market readiness.

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Published as part of PharmaPack Showcase feature in Manufacturing Chemist | February 2025

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