Sustainability Challenges of Single-Use Technologies

Each production run produces a set of fossil fuel-derived consumables—bioproduction containers (BPCs), tubing, filters, connectors, etc.—destined for incineration or landfill, with few viable pathways for recovery. As industry leans ever further into disposability to meet global therapeutic demands, it must now confront a pressing question: can the environmental cost of convenience be mitigated without compromising the very efficiencies that SUTs were designed to deliver?

This article examines the sustainability challenge through the lens of materials and end-of-life options for single-use bioprocessing. It begins by characterizing the polymers and composites used across films, tubing, connectors, and rigid components, highlighting why multilayer structures deliver performance but resist conventional recycling. The article then reviews current recycling pathways, distinguishing mechanical recycling options (including sorting and downcycling programs) from chemical recycling approaches such as pyrolysis, gasification, and solvent-based separation, and summarizes where pilot efforts are beginning to test feasibility in healthcare-relevant waste streams.

Next, it outlines the principal barriers that limit scales (e.g., material complexity and sorting burden, hazard status), and the presence of problematic constituents (e.g., halogenated or metal-containing components) that can degrade advanced recycling methods. Finally, the discussion highlights near-term “quick wins,” such as segregating homogeneous packaging waste streams. This article sets the stage for subsequent work focused on real-world monoclonal antibodies (mAbs) case studies and scaling solutions that can move SUTs from a linear consumption model toward a more circular, sustainability-by-design future.

Table 1: Common plastic materials used in single-use systems.

Background

The biopharmaceutical industry has undergone a transformative shift over the past two decades with the increasing adoption of SUTs. These systems—encompassing disposable bioreactors, tubing, connectors, filtration units, and mixing systems—have proven to be pivotal in enabling flexible, cost-effective, and contamination-resistant biologics manufacturing. Especially for mAbs, SUTs have facilitated rapid scale-up and technology transfer, supporting global demands for therapeutic proteins. However, the growing reliance on single-use components has raised pressing questions about their environmental sustainability, given the significant use of fossil fuel‑based plastics and limited end-of-life processing options.

Although some argue that SUTs offer net environmental gains through reduced energy, water, and cleaning agent use1, others challenge this perspective, highlighting the contradiction between disposability and long-term ecological stewardship2. Stainless steel systems still carry a large environmental footprint largely due to under optimized cleaning processes. As an example, overkill cycles waste most of the energy and resources used. This highlights the need to avoid repeating the same mistake with single-use systems, ensuring sustainability by embedding optimization, circularity, and sustainability-by-design principles from the outset. Adding to the conversation, a closed-loop recycling concept for small-scale bioreactors has been proposed3, illustrating that technical solutions for plastic recovery are within reach, albeit in early stages.

Typical Plastic Materials Used in Single-Use Manufacturing

Single-use systems for bioproduction typically incorporate multilayer polymer films, tubing, and rigid components engineered for mechanical strength, pumping, temperature or pressure resistance, chemical compatibility, and barrier performance.

Multilayer structures are usually co-extruded or laminated, making them highly functional but also difficult to recycle due to the incompatibility of fused polymers in conventional recycling streams (see Figure 1).

Figure 1: Sketch of 3D hold bag.

The biopharmaceutical industry has undergone a transformative shift over the past two decades with the increasing adoption of SUTs.

Options for Recycling Single-Use Plastic Materials

Mechanical Recycling

Mechanical recycling involves shredding, melting, and reforming plastic waste into new products. This method is most feasible when dealing with single-material streams, and flexible or rigid plastics must be segregated because they do not fall into the same recycling process. Most multilayer films in SUTs typically prevent this due to material incompatibility (some films made of PE/EVOH only have been proven to be mechanically recyclable4). However, some progress has been made in separating and downcycling certain components:

• Cleanroom waste sorting: Programs have been initiated to collect and sort rigid PE and PP components for localized recycling (e.g., collection bins at biomanufacturing sites), sometimes back into laboratory consumables.
• Third-party partnerships: Companies have partnered with biopharmaceutical firms to collect and mechanically process single-use laboratory and bioprocess container film waste into plastic lumber1.

One challenge is that most available options are oriented toward downcycling, meaning that high-quality plastics (as pharmaceutical industry requires high-quality and validation standards) will end up in low-value plastic materials like lumber. Even if the closed-loop option seems unrealistic today, one can at least seek a valuable open-loop (e.g., food industry) or semi-closed-loop option.

Chemical Recycling

Chemical recycling technologies—including pyrolysis, gasification, and solvent-based depolymerization—offer greater potential for mixed or multilayer plastics. These methods can break down polymers into monomers or oils that are reused in polymer synthesis or energy generation.

Pyrolysis is the process of heating plastic up to temperatures up to 900°C with a lack of oxygen. Gasification decomposes materials into simple molecules, mainly CO and H₂, and can produce synthesis gas (“syngas”) for conversion into petrochemical products, making it able to transform into oil or gas (as fuel) or to create second-life products. It has shown promise in converting mixed plastic waste into synthetic crude oil. Solvent-based separation can selectively dissolve certain polymers for recovery while removing contaminants.

Pilot programs are underway to evaluate the economic and regulatory feasibility of applying these techniques to SUTs in regulated environments. These programs have included performing feasibility for compatibility of healthcare and SUT materials of construction with various chemical recycling technologies5^, 6. Mixed-material composition of these product types can pose challenges to recycling, and these studies can inform potential improvements to help enable design that is compatible with recyclability.

Challenges to Recycling Single-Use Bioprocessing Materials

Notwithstanding technological potential, several barriers currently inhibit the widespread recycling of single-use bioprocessing materials.

Material Complexity and Sorting Procedures

Multilayer films, rigid components, and accessories that comprise multiple material types are hard to separate into individual polymers or components for recycling. It also requires labor from laboratory personnel or other staff to sort properly and prepare for recycling.

Biological Contamination

Used SUTs may be classified as biohazardous waste, depending on their use, which necessitates post-use heat sterilization that is destructive for plastic films and incompatible with further sorting and recycling processes. In many cases, single-use systems used in classified environments are, by default, directed to the biohazard waste stream, even when the materials have not had potentially hazardous biological contact, often for the sake of simplifying waste streams and applying the regulatory precautionary principle.

Industry studies estimate that only 20%–30% of waste from the biopharmaceutical industry is hazardous, whereas, in practice, it is observed that 70%–80% is treated as biohazardous by the user sites.

Lack of Infrastructure

Few facilities are equipped to handle the sterilization, sorting, and specialized recycling of bioprocessing plastics. Many waste management companies do not have SUT waste on their radar or are not considering the potential business as profitable enough to justify further investigation.

Chemical recycling technologies—including pyrolysis, gasification, and solvent-based depolymerization—offer greater potential for mixed or multilayer plastics. These methods can break down polymers into monomers or oils that are reused in polymer synthesis or energy generation.

Regulatory Ambiguity

Unclear guidelines on recycling and reuse in GMP settings may discourage companies from pursuing recycling programs.

Cost

Current recycling methods may be more expensive than incineration or landfill disposal, though this varies by geographical region, local regulations, infrastructure network, and costs for sorting, storage, and transportation of the materials concerned. Waste management companies and their recycling partners are looking for profitable businesses with large quantities of same plastic materials (e.g., tons of Polyethylene (PE) or Polycarbonate (PC)), whereas single-use bioprocessing materials are diverse and often made of different plastic materials. Given the weight of recyclable plastic material into a single-use bag, a bioprocess facility may have to store one year of sorted plastic material to reach one ton of plastic waste.

Limited Recycling Outlets

Even when recycling options exist, it may be required to transport the materials for distances of hundreds of miles to be delivered to recyclers, thereby adding to the emissions footprint.

Cross-Contamination Risks

These risks include, specifically, potential product or drug substance contamination during recycling processes. These are beyond the scope of this article and are therefore not addressed herein.

Opportunities to Address These Challenges

There is a growing recognition across the industry that addressing these challenges is essential to meeting long-term sustainability goals. Potential opportunities include the following.

• Designing for recyclability: Developing single-layer or compatible multilayer films that allow for recycling
• Standardizing materials: Harmonizing material selection across suppliers and end-users (based on their suitability to fall into identified recycling streams) can help streamline recycling processes; several key industry workstreams are working on standardized solutions for SUT applications
• Establishing takeback programs: Manufacturers can establish programs to collect used SUTs for centralized recycling or energy recovery
• Creating collaborative platforms: Industry consortia can pool resources to develop shared infrastructure and best practices
• Thoughtfully select waste management and recycling partners: It should be noted that the end user must onboard waste management companies and their recycling partners, as owners are responsible for post-use SUT recycling; supplier focus is on ensuring recyclability of their products
• Engage with regulators: Working with regulators to define safe, compliant recycling pathways for certain categories of SUT waste
• Integrating with circular economy principles: Embedding life cycle thinking into SUT design and procurement can create a shift from linear to circular production models

Several industry studies over the years have shown that SUTs have fewer negative environmental impacts than traditional biomanufacturing when assessing the full life cycle.

Exploring Future Innovations in Sustainable SUT Design

Material Innovation for Sustainability

As the bioprocessing industry seeks to balance performance, reliability, and environmental responsibility, material innovation emerges as the cornerstone of sustainable SUT design. Future progress depends on rethinking how materials are sourced, processed, and reintegrated into circular systems. This includes developing polymers tailored for recyclability, optimizing formulations for waste processing, and conducting robust life cycle assessments (LCAs) to quantify and minimize environmental impacts across the product’s entire lifespan.

By integrating these principles with frameworks such as International Sustainability and Carbon Certification (ISCC) PLUS certification, manufacturers can ensure traceable, responsibly sourced materials that support both regulatory compliance and sustainability commitments. The following material-focused strategies illustrate key pathways toward achieving these goals:

• Mono-material films: Replacing complex multilayer films with mono-material polymers—such as recyclable PE or PP—can greatly enhance recyclability while retaining key functional properties through coatings or additives
• Mono-material accessories: Making accessories out of materials that are similar to the films can allow for recycling all components together without requiring physical separation for processing. There is acknowledgement that there is likely to be a mix of materials of construction (MOCs) between connectors, tubing, and flexible and rigid SUTs
• Bio-based plastics and renewable feedstocks: The incorporation of bio-based, renewable, second-generation feedstocks from biomass waste for the manufacture of plastic resins and subsequent incorporation into bioprocessing products can reduce the upfront carbon footprint while still resulting in the same quality and specification materials
• Additive-free formulations: Minimizing the use of stabilizers, adhesives, and pigments simplifies recycling and reduces chemical burden in post-use waste

In a true circular economy, recycled feedstocks are the primary enabler, as they keep materials in continuous use and minimize the need for new inputs. Bio-based feedstocks play a complementary role by providing renewable, non-fossil resources where recycled options are insufficient.

International Sustainability and Carbon Certification (ISCC) PLUS certification

ISCC PLUS is a globally recognized certification system for sustainability and carbon reduction. It is widely applied in the chemical, plastics packaging, and food industries to ensure transparency and traceability of sustainable materials along the value chain. A key element of ISCC PLUS is the mass balance approach, which allows certified companies to mix sustainable and conventional raw materials in their production while keeping strict accounting of inputs and outputs. The mass balance system ensures that the share of sustainable materials put into the process is accurately allocated to specific products. This approach makes it feasible to gradually replace fossil fuel‑based resources with renewable or recycled alternatives, thus allowing de-fossilization while maintaining existing infrastructure and product quality. It supports the transition to a circular economy.

Circular (Semi- or Closed-Loop) Recycling Systems

Circularity is a transformative approach to sustainability, where products are designed, used, and recycled continuously, reducing waste and conserving resources. SUTs historically have been difficult to recycle. Some studies show that approximately 14% of the SUT waste generated in the manufacturing process is actually hazardous, whereas the remaining 86% is nonhazardous. Addressing challenges associated with this nonhazardous majority would therefore yield significant overall impact7. When deemed hazardous or regulated medical waste, SUTs may not be eligible for traditional recycling programs.

In addition, SUT bags are made of multilayer film and contain attachments constructed of various materials; it can be difficult to find recyclers willing and able to disassemble these. In some cases, manufacturers use SUTs that are larger than 5,000 liters. This can hinder the user’s ability to fold down bags to fit in pallet boxes for recycling, which creates a need for onsite waste processing. Industry modeling estimates SUT waste to be about 2,000 tons per year7, making the waste less appealing due to the lower volumes and mixed plastics. Recycling solutions that do exist are available by country and not globally.

Several industry studies over the years have shown that SUTs have fewer negative environmental impacts than traditional biomanufacturing when assessing the full life cycle that encompasses resource extraction, processing, product manufacturing, and end of life. Still manufacturers and suppliers are concerned about the ability to recycle SUT bags and avoid landfill and incineration. It should be noted that the evaluation is scenario dependent, based on both scale and run rate compared to stainless steel and SUT sustainability benefits. As an industry, we must acknowledge and accept our shared responsibility to address the waste that these products leave behind.

Focus areas

The following is a noncomprehensive list of focus areas that will need to be more fully explored for existing approaches and solutions. This includes methods such as onsite disassembly, sorting, and cleaning, as well as an assessment of the substantial portion of emissions from single-use systems (SUS) that arise solely from handling and transport within the recycling and disposal chain. These aspects will be explored in greater depth in an upcoming article dedicated to evaluating current practices and identifying opportunities for improvement in SUS sustainability.

• Onsite waste processing units: Development of modular, GMP-compliant sterilization and plastic reprocessing units can enable management of biohazardous wastes directly within manufacturing facilities, decreasing the overall impact (financial and environmental) of such activities. Several companies offer such units with both large and small footprints to meet the needs of different facility space constraints8^, 9.
• Design for disassembly: New SUT products can be engineered for easier separation of components at end of life, allowing sorting by polymer type.

Digital Waste Tracking and Life Cycle Analytics

These activities should focus on waste stream mapping, LCA, and material flow analysis (MFA). Waste stream mapping is real-time data collection on usage, sterilization status, and material type, and it can optimize recycling logistics. Embedding LCA into process design allows manufacturers to select materials with lower overall environmental footprints. MFA is a data-driven method used to quantify the flows of materials over a specific time. It tracks materials from extraction through production, use, and disposal, commonly using Sankey diagrams to visualize resource efficiency, bottlenecks, and environmental impacts10.

Policy and Industry Standardization

Standardization around these should focus on two primary areas: global recycling standards and incentivized takeback programs. Establishing harmonized guidelines for acceptable materials and recycling methods can accelerate adoption across geographies. And regulatory or industry-led incentives can support the development of SUT recovery programs by offering economic benefits for returned materials.

Case Study: MOCs Used in mAb Manufacturing

This case study’s objective is to determine the volumes of plastics used across the industry and to characterize the materials that comprise the waste stream. The classification, quantification, and characterization of waste streams provide the input for developing a waste management strategy.

In the original study, mAbs were taken as the dominant product class representing the large bulk of the biomanufacturing capacity, standing at about 98% in volume terms and representing a significant (85%) percentage of products in development. Understanding the nature of the waste stream, its composition, and the relative amounts allows informed decisions to be made regarding waste management in the short and long term.

This data allows recyclability assessments to be made, identifying the quick wins and enabling the prioritization of key components and materials to improve their recyclability or reuse. Given the complexity of the SUS and the different makeup of the many suppliers, the approach to conducting this assessment is described next.

The focus is on monoclonal antibodies for the reasons outlined previously. By analyzing the manufacturing processes at a variety of scales and identifying the common technologies deployed, it is possible to build up a list of bill of materials (BOM) and identify the standard components used in biomanufacturing. Table 2 lists the typical types of single-use components used to manufacture mAbs.

Table 2: Typical types of SUS.

The following approach is used to analyze the materials and assess their recyclability based on the component and the BOM associated with a batch. This approach is illustrated by considering the material analysis of a 3D hold bag.

1. Identify the key manufacturers’ product range based on types and sizes.
2. For a given type and size, classify the materials within the assembly in terms of the weights used in the individual product.
3. Based on the classification, determine the average material composition and weights that represent that product type and size based on the composition and weights of all the products of that type and size from the different vendors.
4. For each product type and size, assemble a list of typical compositions and weights and use this as a reference point for the BOM. Assemble a batch breakdown of product types and sizes classified in terms of the material.

A typical 3D bag from all the manufacturers would have the following components: clamps, various tubing lengths and sizes, multilayer film, connectors, and miscellaneous.

To provide an understanding of approaches to recycling components, the weights of each product type and size were averaged across the leading vendors. An example of this is given for hold bags in Figure 2. By classifying components in terms of the construction materials for the various sizes, the actual amounts of each material can be determined and associated with the exact components.

Figure 2: Average weight of 3D hold bags.

Classification by material type allows for standardizing the categorization of materials across suppliers, providing a simplified approach to analyzing these waste streams. In the case of the 3D hold bags, the analysis of components is given in Table 3. Combined with the weights shown in Figure 2, this allows an estimation of the typical quantities of materials associated with each bag size. Analyzing across vendors makes identifying standard components and materials and their key differences possible.

Table 3: Breakdown of the materials in typical hold bags.

In the case of the 3D hold bags, if just the film is considered, the following observations can be made. All film systems use EVOH as the primary barrier layer and incorporate polyethylene variants (e.g., linear low-density polyethylene (LLDPE), polyethylene (PE), ultra-low-density polyethylene (ULDPE)). They tend to differ in terms of structural complexity, which varies significantly from 3×10 layers, film thickness, and product enhancement.

By applying this approach to all the components in the BOM (see Table 4) associated with a manufactured batch of mAbs, it is possible to provide a standard overview of all the components and materials used. This holistic approach allows a consistent, standardized approach to evaluating recycling options. This can be considered for multiple scenarios, such as disassembled and non-disassembled. This provides the basis for prioritizing options for the current and future operations.

In the case of the 3D hold bags, it would be concluded that disassembly is required, and the segregation and recycling of the thermoplastics should be considered, as the recycling process is relatively simple and cost-effective. Future work and evaluations will focus on evaluating the handling and manufacturing of multilayer films.

Table 4: Sample partial BOM.

The sustainability of SUS in biopharmaceutical manufacturing remains a complex but critical issue.

Advanced Recycling Techniques

Advanced recycling techniques often require an inert environment, posing a challenge for highly heterogeneous waste streams. Oxygenated and nitrogenated plastics introduce reactive species to the inert environment, posing risks for continuous recycling processes. The products of pyrolysis, for example, need to be an acceptable feedstock for steam cracking and in addition to corrosion and health concerns, nitrogen, sulfur, oxygen halogens, and metals can cause fouling, increased coke formation, and poison downstream catalysts11. These unfavorable byproducts restrict composition of recycling feedstocks, making waste stream sorting or filtering necessary for efficient pyrolysis.

Although all contamination presents risks, not all contamination poses the same risk. Oxygenated plastics are undesirable, but the byproducts produced can be managed if kept under critical levels. Conversely, halogenated materials need to be more closely regulated, as the acidic byproducts cause significant damage to process equipment and pose a risk to human health even at low concentration12. The following bioprocessing materials may pose challenges to recycling efforts:

• Metal components: Built-in sensors, single-use impeller housing, tubing fasteners
• Halogenated components12^, 13
• Polyvinylidene fluoride (PVDF): Filter membranes and oxygenated, nitrogenated, sulfonated plastics

Although bioprocess equipment and consumables use complex materials for their novel properties and have justifiable application in complex bioprocess, the packaging used to ship these materials is homogeneous and standardized. Double poly bags and bubble wrap make up much of the packaging outside of cardboard boxes and are both made from LDPE, a desired pyrolysis feedstock. Because cardboard boxes are discarded in the warehouse and recycled in their own waste stream, outer packaging poses an opportunity for an easily separated homogenous waste stream. In operations, packaging is removed before operations, whereas consumables are discarded after. This means there is a natural separation of packaging and consumable products on the floor. If production suites have two waste vessels, one for strictly packaging and another for process waste, manufacturing could capture the full 33% of plastic waste that comes from packaging without any sorting and implied interruption to operations7^, 14.

The exploration of problematic materials, from heavy metals and nylon cords to steel inserts and embedded subcomponents, underscores the complexity of recycling SUTs. Each nonconforming element complicates waste segregation and also diminishes the viability of high-value material recovery. The next logical step is to tackle the question of how these mixed-material systems can be effectively separated and reprocessed at scale.

A forthcoming article will delve into real-world case studies, emerging sorting technologies, and collaborative opportunities between biopharmaceutical manufacturers, recycling innovators, and waste management companies. By examining current industry pilots and commercial recycling partnerships, we will illuminate pathways that can transform today’s waste challenges into tomorrow’s sustainability successes.

SUTs have transformed biopharmaceutical manufacturing by enabling sterility, flexibility, and cost efficiency, especially in mAb production. However, their increasing use has created a mounting sustainability challenge: large volumes of petroleum-based, multilayer plastic waste that is typically incinerated or landfilled due to limited recycling options.

Conclusion

The sustainability of SUS in biopharmaceutical manufacturing remains a complex but critical issue. Although these systems deliver clear operational and cost benefits, their environmental impact cannot be overlooked. A balanced approach, leveraging design innovation, advanced recycling technologies, and industry and regulatory collaboration, is essential for aligning the benefits of disposability with the imperatives of sustainability. The path forward lies not in discarding SUTs altogether, but in reimagining their life cycle to support both scientific progress and environmental responsibility.