Drug Delivery Device Design: Finding Environmental Hotspots Through Lifecycle Assessment

Drug delivery device manufacturers face increasing pressure to reduce their environmental footprint, particularly when it comes to drug device combinations, which rely heavily on single-use plastics and complex supply chains and generate significant waste. Given the growing market for such devices, essential for the efficacy of many novel drug modalities such as biologics and nucleic acids, it is crucial that they are made as sustainable as possible if industry net-zero targets are to be met.

Lifecycle assessment (LCA) has emerged as a critical tool for identifying environmental impact across the entire product lifecycle, from raw material sourcing to disposal. Unlike isolated initiatives that focus on one element of sustainability, LCAs provide a holistic view, allowing manufacturers to make informed decisions and design choices that balance environmental benefits with safety, regulatory compliance, and functionality.

As a structured methodology for evaluating environmental impacts throughout a product’s lifecycle, LCA is a powerful, data-driven tool for driving sustainability across a range of industries. Globally recognised standards like ISO 14040 and 14044 set out not only a general framework but also detailed guidelines and requirements for conducting an LCA, ensuring consistency, comparability, and credibility for companies that apply them. As per ISO 14040, the four key stages of LCAs are:

1. Goal and Scope Definition: Establishing objectives, system boundaries, and sustainability metrics.
2. Lifecycle Inventory: Compiling data on relevant inputs and outputs.
3. Lifecycle Impact Assessment: Evaluating environmental impacts in different categories, such as climate change, human toxicity and water use.
4. Interpretation: Assessing the results in relation to the defined goals and scope.

To streamline the use of this powerful yet complex methodology, Owen Mumford Pharmaceutical Services has worked with a leading consultancy to develop a lifecycle-based eco-design tool that covers 17 potential impact categories and provides an estimated impact score to facilitate understanding and communication of results across the company.

Using the baseline impact score established with LCA, it is possible to pinpoint environmental hotspots—moments in the product lifecycle where the most significant environmental impacts occur. In drug delivery device manufacture, these hotspots often include aspects occurring upstream or downstream in the company’s value chain that are outside the manufacturer’s direct sphere of influence, including raw material sourcing, distribution & logistics, and end-of-life disposal.

Regulatory constraints, for example, mean that virgin materials, in particular single-use plastics, are overwhelmingly dominant. The production of these materials contributes significantly to carbon emissions and resource depletion. Further downstream, long-distance transportation, complex supply chains and storage requirements (cold chain) increase emissions, while packaging generates additional waste. And finally, multi-material construction, hygiene risks and regulatory barriers mean that many drug delivery devices are difficult to reuse or recycle.

Once an LCA has revealed the environmental hotspots of a product system, it is then possible to build scenarios to analyze how best to address these areas. The resulting data makes it possible for manufacturers to evaluate multiple options, such as different material choices or changes to the manufacturing process, and determine the overall impact of these potential modifications.

As an example, a single-use disposable auto-injector currently has a carbon footprint of approximately 400g CO₂e. By transitioning to a reusable, remanufacturable device, this figure could be reduced to 19g CO₂e. However, obstacles remain; there is currently no process or industry methodology in the UK or globally to facilitate the return, disassembly, and reintegration of these devices into manufacturing and supply chains, including the pharmaceutical industry and healthcare systems.

Although LCAs provides a framework for evaluating environmental impacts, the decision-making process in the drug delivery device field is particularly challenging due to complex global supply chains and the multiple factors involved. Not all sustainability choices lead to clear-cut improvements, and seemingly obvious changes may introduce unintended consequences elsewhere in the supply chain.

Striking a balance is not always easy: increasing robustness may help prolong a product’s useful life, but it has knock-on effects on transportation weight and emission factor per unit mass, potentially outweighing the expected environmental benefits. And conversely, lightweighting can lower manufacturing and transportation emissions but may compromise device durability, negating initial sustainability gains.

The strict regulatory context of the drug delivery device industry means that substantial changes to the materials used to manufacture devices remain unlikely. Nevertheless, transitioning to bioplastics could offset industry reliance on fossil-based plastics and boost sustainable product design. Careful analysis remains essential, however, given the potential trade-offs associated with bio-based plastics, including negative agricultural impacts, competition with food production, unclear end-of-life management and higher costs. The allocation of sequestered carbon (CO2 absorbed by the feedstock material) must also be taken into account.

To bring about meaningful reductions in environmental impact, sustainability must be embedded in every stage of the product design process. Where an LCA approach is adopted, it should be integrated at the earliest stages of development, ensuring that sustainability considerations are not an afterthought. This also means that circularity can be built in from the very start of a project, designing for longevity and highest-value reuse by minimizing device complexity to make them cheaper and easier to recycle.

Flexible drug delivery devices, which allow for compatibility with a variety of formulations, fill volumes, needle sizes and primary containers, can also offer advantages in terms of streamlining manufacturing, with efficiency gains and a reduction in the environmental impact of combination products at the manufacturing stage. Other disruptive approaches, such as rethinking device briefs according to the state of the drug product—one example is to lyophilize (freeze-dry) the drug and then recombine it through the device at the point of administration—can have a significant impact in terms of increasing drug stability and shelf life.

As increasing emphasis is placed on environmental, social, and governance (ESG) reporting and sustainability requirements (e.g., in the EU MDR), LCA is becoming an indispensable tool for guiding the industry towards more sustainable drug delivery device design. By identifying environmental hotspots and enabling data-driven decision-making, LCAs can help manufacturers make smarter, more sustainable choices while navigating the trade-offs and challenges inherent in the process.