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The Green Imperative Part Two — Engineering for Sustainability in Single-Use Technologies

Magali Barbaroux, Brian Horowski, Sade Mokuolu, Mark A. Petrich, Mitchell Snyder, and William Whitford, with the BPSA Sustainability Subcommittee

n BPI’s June 2020 issue, the first Plastic and Healthcare installment of this series introduces Even though SU applications in the study and implementation of healthcare are rarely criticized — and single-use (SU) technology to provide despite the fact that plastic packaging aI more sustainable manufacturing used in healthcare products represents environment (1). We presented evidence under 2% of total plastics produced each showing that the economic and social year — circularity guidelines for benefits of SU systems currently packaging do not exclude outweigh the residual environmental pharmaceutical packaging from their risks. Not only is SU technology often a scope (4). As the World Health better environmental choice than Organization has stated, “Of the total traditional biomanufacturing options, it amount of waste generated by also is sometimes the only choice for healthcare activities, about 85% is rapid process design and facility general, nonhazardous waste” (5). A start-up. In situations such as the HTTPS://STOCK.ADOBE.COM significant amount of plastic used in current pandemic, SU systems are healthcare can be reclaimed through instrumental to developing new drugs industry to transition from a linear- to a standard recycling means. and vaccines quickly and safely. circular-economy approach that will In the business-to-consumer market, Below we outline current thinking on recover value from plastic materials and the pharmaceutical industry is how to design materials, systems, and help protect the environment. The new addressing the use of plastic responsibly processes to support the “rethink, plastics economy initiative (Figure 1) and creatively by introducing circular- reengineer, reduce, reuse, and recycle” encourages manufacturers and marketers design principles for final packaging. paradigm of the circular-economy to foster innovation in the plastic For example, Boehringer Ingelheim’s concept for plastic and packaging. industry by adding “rethink” and reusable inhaler and Huhtamaki’s Through engineering efforts to improve “reengineer” stages to the traditional recyclable blister packaging for tablets sustainability, SU technology will “reduce–reuse–recycle” waste reduction both received awards during become an even better manufacturing strategy. “Rethink” and “reengineer” Pharmapack Europe 2020. technology option in the future. In an actions should be applied at all stages of In the biopharmaceutical industry, upcoming issue, the final installment of the lifecycle for these products: from SU facilities increasingly are recognized this series will describe current and conceptual design to the end of life. The to be more ecofriendly than traditional future “end-of-life” handling methods report encourages manufacturers, facilities. However, the rising use of SU and reprocessing technologies for SU industries, and national organizations to technology is expanding the quantity of systems and components. set and document ambitious goals in a plastic waste generated in “plastic pact” (3). As public concerns biomanufacturing. Managing that The New Plastics Economy about environmental issues such as material according to circular-economy In January 2016, a report on “the new global warming and waste have principles is becoming more important plastics economy” was published by the increased in recent years, governments as SU consumption continues to grow. World Economic Forum and the Ellen and policy makers have begun to draft Below, we present concepts and MacArthur Foundation with analytical laws and guidelines for pushing the practices that can help the SU and support from McKinsey and Company (2). plastic industry to adopt strategies biopharmaceutical industries move The report invited the plastic-packaging outlined in the report. toward that circular economy. Product

18 BioProcess International 19(1–2) January–February 2021 Figure 1: New plastic economy circularity guidelines (1, 2) design, selection of raw materials with 1) Create an eective after-use plastics economy. Other material streams an eye toward recyclability, reduction of materials, reuse opportunities, Recycling improved SU production practices, and Radically improved economics and quality improvements in process design and biomanufacturing use of SU are addressed. Postuse processing of SU 2) Drastically waste and reprocessing opportunities Reuse reduce leakage will be covered in our third and final of plastics into installment in this “Green Imperative” natural systems series. and other negative Circularity in Design externalities. Design and g Use in and Manufacturing Production st po It is important to include entire SU m co fill, systems when considering how to move Renewably Sourced Land toward a circular-economy paradigm. Virgin Feedstock Energy recovery The main objective of product design is Leakage 3) Decouple plastics from fossil feedstock. to guarantee that a product functions as intended at every step of its lifecycle. SU technologies need to meet a number of and handling from the end of SU processing components and their requirements (6): They must withstand manufacturing to the point of use. SU packaging. Evaluating plastic gamma irradiation, maintain integrity components typically are shipped in consumption through a product lifecycle during transportation and storage, serve cardboard boxes and often are packaged highlights opportunities for reducing their function as bioprocessing system within two heat-sealed plastic pouches. plastic waste. Some examples of how to components, and be manageable as One pouch is removed as the SU is apply that evaluation process process waste. Trade-offs between transferred through an airlock into a (“rethinking” and “reengineering”) are bioprocess performance and biomanufacturing clean room, and the listed in the “Evaluating Consumption” recyclability must be identified and other is removed at the point (and time) box. assessed. Material engineers’ goal is to of use. Recycling has a two-part impact on meet both sets of requirements, but Note that packaging materials can be material selection: Products can be achieving that goal is a challenge. collected without biocontamination and designed with recyclable materials and/ Biopharmaceutical industry users are recyclable in standard collection and or integrate recycled materials. Briefly expect attributes such as mechanical reprocessing streams. Additional described herein to help understand robustness and chemical resistance to packaging items such as bubble wraps, their impact on materials selection, meet process needs across a wide range foam sheets, tape, and cable ties used to these methods will be detailed further of conditions. Material choices are organize and protect subcomponents of in the conclusion of this series. influenced by the need to operate from complicated assemblies such as The new plastic economy strategy –80 to +60 °C. Product-contact bioreactors and mixers also may be encourages use of recycled materials and materials must be designed to minimize recyclable. For some applications, (when that is not possible) manufacture extractables, and particular attention packaging must be resistant to cleaning of plastics from renewable feedstocks has been given to the material agents such as isopropanol, aqueous such as sugar cane. An example of chemistry of bag films for SU containers disinfectants, and sporicides. Resistance plastic made from renewable feedstock is (7). Minimizing extractables is not to vaporized hydrogen peroxide (VHP) is plant-based polyethylene terephthalate necessarily compatible with optimizing important for SU components used in (PET) used in some beverage containers. other performance attributes or with the isolators. Cleaning and disinfection Most SU products (and their plastic goal of recyclability. Some material requirements could force designers to packaging) used today are manufactured selections are tied directly to select less-commonly recycled materials from virgin material (first-use, not performance of SU systems in mixing, such as multilayer film bags. The ratio recycled) that comes from fossil-fuel draining, filtration, and other process of plastic weight involved in packaging feedstock. Opportunities to integrate applications. And customers are to that of the product is usually ~10%. recycled materials and/or plastics made interested in long shelf lives of SU “Reduce” and “Recycle” Circular from alternative feedstocks in SU components, which puts further Goals: From material-design and products should be explored. demands on material engineers. management perspectives, reducing the Material Selection: The generic term Packaging is part of a SU product. It amount of material while meeting plastic covers many materials designed is intended to protect the processing specifications without compromising to meet very different needs for components from mechanical stress and product functionality is part of design thousands of customized user-defined contamination during transportation best practices. That applies to both SU applications. Plastics are synthetic

January–February 2021 19(1–2) BioProcess International 19 Figure 2: Overview of different loops for plastics in a circular economy (11) by consultant Mats Linder (MLSH Consulting AB) In addition to patient safety, SU designers must consider bioprocess Closed-Loop performance. For example, after cell Pathways growth issues were reported by users of SU bags, a new generation of film was

Depolymerization developed (8). An antioxidant is required to protect polymers during film Mechanical Virgin recycling manufacturing, gamma irradiation, and Solvent- Noncircular feedstock Feedstock based pathways storage. A legacy antioxidant was recycling purification Reuse identified as the cause of the cell growth Refining Polymerization Formulation Processing Packaging Use difficulties. In response, alternative antioxidants were evaluated and their Monomer Polymer Plastic Application Packaged Product concentration optimized to achieve the necessary film properties for cell culture Table 1: What is a biopolymer? The word must be used cautiously and is not specific use. Next-generation films can be used enough to describe the “bio” aspect properly. Indeed, the same wording covers the origin without releasing harmful byproducts of the carbon that constitutes the polymeric backbone (biologically sourced) as well as during their lifecycle, and they can be degradation processes of polymers (biodegradable). Don’t confuse biosourced with biodegradable polymers (10). produced with batch-to-batch consistency (9). Change-control Biosourced Polymers Biodegradable Polymers procedures are in place with all Definition The qualificative bio refers to the origin of The qualificative bio refers to the stakeholders along the supply chain to the carbon that constitutes the polymeric degradation process of the polymer and its backbone. These are made partly or fully ability to break down into simpler substances ensure that impurity profiles remain from organic matter (from plants and through the action of microorganisms under unchanged and that harmful animals), often combined with fossil sources. specific conditions. ingredients are absent. Disposal Under 40% of biobased plastics are There are different types: industrially The new designed to be biodegradable. compostable, home compostable, soil Plastic Recycling Methods: biodegradable, and marine biodegradable plastic economy defines two recycling plastics. methodologies: mechanical and chemical Example Biobased plastics such as polyethylene (PE), Polylactic acid (PLA) is an aliphatic polyester recycling (Figure 2). Neither is “better” polyethylene terephthalate (PET), and synthesized from fermented plant starch. It is than the other; they complement each polyamide (PA) made of sugar cane are not compostable, but nonbiodegradable biodegradable. according to American and European other, and each is used when and where standards because it does not biodegrade it makes the most sense to do so. outside of artificial composting conditions. Mechanical recycling of plastic is a multistep approach. For best results, the materials made from a wide range of When designing SU products, plastic must be as pure as possible. It is organic polymers such as polyethylene manufacturers often distinguish collected, sorted, shredded, and cleaned (PE), polypropylene (PP), polyvinyl between product-contact and non– — then melted, extruded, and pelletized chloride (PVC), polycarbonate (PC), and product-contact materials (e.g., external to be used again as a raw material. Not many others. Those are mixed with components layers, packaging, and other all plastics can be recycled this way. The additives, chemical compounds that external parts). Designers must consider two main categories of polymers are protect polymers and improve material bioprocess risks to select the best thermoplastics and thermosets. performance. Oxidation and UV light materials that will contact bioprocess Thermoplastics (e.g., polyethylene) are resistance, fire-retardant properties, and fluids. For example, priority must be polymers that can be melted when physical properties such as puncture given to materials with low extractables heated and hardened when cooled. Those resistance all can be adjusted with and an absence of harmful additives. characteristics are reversible and suitable additives. A complete chapter of Materials used in the bioprocess repeatable, allowing for mechanical the MacArthur Foundation report is industry are selected carefully to comply recycling to convert used plastic into new dedicated to plastic materials safety in with pharmacopoeias and regulations plastic products. By contrast, thermosets all product lifecycle phases, including such as REACH (Registration, (e.g. silicone) are polymers that undergo removal of all substances of concern (2). Evaluation, Authorization, and a chemical change when heated. After Removing additives that are unsuitable Restriction of Chemicals) in Europe. The they are heated and formed, thermosets for use in the biopharmaceutical latter prevents plastic-containing cannot be remelted and reformed. industry has been a focus of much effort impurities such as bisphenol A (BPA), Primary mechanical recycling of in development of industry-specific phthalates, melamine, and so on from plastics converts thermoplastic materials such as bag films. Bag-film being used in the manufacturing of polymers into products with equivalent engineering has produced a number of drug products. By design, the REACH properties. Such closed-loop processes plastics and combinations thereof regulation aligns with plastic material can be applied only for plastics that designed to meet the specific safety as stated in the circular economy have not been used at all or that have requirements of bioprocessing. guidelines (2). been decontaminated thoroughly before

20 BioProcess International 19(1–2) January–February 2021 Figure 3: The ASTM International Resin Identification Coding (RIC) system facilitates recycling of plastics (12). between competing design requirements (recyclability being just one of those). Materials of construction are key to the 1 2 3 4 5 6 7 recyclability of a product. Plastics are PETE HDPE V LDPE PP PS Other classified into seven categories according to resin identification codes (RIC), a system described in ASTM D7611 Evaluating Consumption (12). Based on their RICs, products can Plastic-component manufacturing plays a important reduction of food spoilage and be recycled properly while preserving large role in plastic reduction. Technologies waste, the food industry increasingly is using their value. ASTM D7611 provides codes such as injection molding or additive films that are not recyclable in standard for six commonly used resin types, with manufacturing are better material-saving collection and reprocessing streams. a seventh category created for all other options than machining, which requires Packaging material use can be optimized by types. The categories are polyethylene removal of material that becomes waste. increasing the number of products contained terephthalate (PETE); high-density Controlled and optimized plastics within the same package. Bulk packaging polyethylene (HDPE); polyvinyl chloride manufacturing also decreases plastic waste. serves not only to reduce the amount of (V); low-density polyethylene (LDPE); Scrapless manufacturing processes (e.g., hot- packaging per product, but also to decrease runner injection molding) are preferable to polypropylene (PP); polystyrene (PS); a product’s footprint during shipping and those that generate waste (e.g., cold-runner and others, including materials made storage. Design of standard SU modules injection molding). with more than one resin from categories would enable packaging optimization. 1–6. Most plastics used in SU systems for Designers need to solve conflicting When new components are integrated into a biomanufacturing are polyolefins such requirements and make trade-offs. The manifold, the handling ability of integrators as LDPE (4 in Figure 3) or PP (5 in Figure struggle to optimize protective films for food and end users should be considered, along packaging is a good example. By reducing 3). Bag films and filters are significant with inclusion of multiple materials and their the amount of plastic — the primary goal of a contributors to plastic weight. impact on postuse processing. The number circular economy — food-packaging films Although thermoplastic items are of connection points that could be damaged have evolved from relatively thick single recyclable in theory, few of them are during shipping and handling should be layers to thinner multilayer films that improve recycled in practice. Most have not been limited and components incorporated that the shelf life of foods. In exchange for designed for compatibility with the address multiple packaging scenarios. lowered material consumption and the current recycling infrastructure. The products that are most easily recycled are those produced from a single-grade recycling. Secondary mechanical be confused with biosource (Table 1) — thermoplastic. That is relatively recycling generally yields products of plastic waste and produce stabilized straightforward for single-component lower mechanical properties than those organic residues or methane. As items, but most users of industrial of the starting materials. Mixed mentioned above, this emerging products have more complex geometric thermoplastic wastes and multilayer recycling method fits into a circular and functional requirements that cannot films used in packaging sometimes can economy only through the idea of be fulfilled by just one material. be mechanically recycled and reused in closing the cycle if biological feedstock Complicated SU products such as lower-value applications such as is used. However, because of unproven bioreactors and mixers have multipiece building and construction. robustness and concerns about and multimaterial constructions. For Chemical recycling breaks down sterilization and shelf life, using such applications, design approaches for polymers into individual monomers or biodegradable polymers for SU product- simplified disassembly should be other hydrocarbon products that serve contact components raises concerns considered provided that they do not as building blocks or feedstock to about validation and risk. compromise assembly safety. Reuse and produce new polymers. This includes Implementation of biodegradable recycling of pinch clamps can be easy to solvent-based purification, materials has low priority for the SU imagine, but simple disconnection of depolymerization, and feedstock and biopharmaceutical industries. tubing from hose barbs after use can be a recycling. The latter describes thermal Designing for recycling has been a challenging design task. The requirement processes that convert polymers into long-time goal of the automobile industry to maintain a tight, sterile, leak-free simpler molecules by either pyrolysis or (11). Efforts there have resulted in connection during filling, draining, and gasification. Theoretically, chemical vehicles that are easy to dismantle, thus pumping seems to be contrary to an easy- recycling can process mixed materials facilitating material separation. The new to-disassemble junction. Recyclability of to generate virgin-quality polymers. plastics economy is pushing designers to plastics is improved by limiting their Organic recycling applies aerobic integrate design-for-recycling concepts special-additives content. Use of natural (composting) or anaerobic into the biopharmaceutical industry, (unpigmented) thermoplastics is (biomethanization) treatment under especially for SU products and packaging. desirable, which is already the case in controlled conditions using SU products first must be fit for most plastic parts used in microorganisms to biodegrade — not to purpose, which involves trade-offs biopharmaceutical applications.

22 BioProcess International 19(1–2) January–February 2021 Recycled Materials: The US Food and market (13). Those originating from Biobased or partly biobased durable Drug Administration (FDA) has started chemical recycling have the same plastics including PE, PET, PVC, PC are to approve some mechanically recycled specifications as fossil-derived plastics technically equivalent to their fossil- postconsumer plastics for food-contact and can be used in like-for-like based counterparts (14). PE made from applications. Apart from PET, few such applications. Polymers are manufactured biobased ethylene has been materials are available on the market from a mix of basic compounds commercialized. A corn-sourced with the quality required for bioprocess originating from plastic waste or fossil isosorbide can be used as a replacement applications. The extractables and raw materials, and the amount of for BPA monomer to manufacture a leachables risk is still too great with recycled material is certified by mass biobased polycarbonate. The first recycled materials in fluid-contact balance. However, offerings are limited, generation of biobased polymers was components such as bag films and and not all technical specifications can criticized because of a perceived conflict tubing. However, the risk is be fulfilled through the available with food stocks; a second generation significantly less for packaging. With portfolio of options. will come from plant-based monomer commitments of consumer-goods and Polymers from Nonfossil Origins: sources that are not food. The overall food-industries leaders, we expect that Renewable feedstocks do not come from production capacity of biosourced the quality of recycled materials will petroleum or coal. They include CO2 and polymers is estimated to be ~2 million improve, ultimately raising methane captured through artificial tons, which represents <1% of global opportunities for their use in packaging carbon-capture and -use processes as plastics production. of SU systems and components. The Bio- well as biosourced feedstocks such as Biological methods are being Process Systems Alliance (BPSA) chemicals derived from sugar cane, developed to reprocess plastic waste, as encourages the SU industry to use corn, and other crops. Not to be well. Emerging technologies that use recycled material wherever possible in confused with biodegradable polymers enzymatic processes to recycle plastic items such as packaging and pallets. It (Table 1), biobased materials are waste and manufacture new polymers would be a good practice also to note the polymers, chemicals, and products have been demonstrated. These percentage of recycled materials used made from biomass, biomass-derived technologies currently are limited to for end-user awareness. byproducts, or CO2/methane derived specific polymers such as PET and have Plastics branded as “chemically from biological processes (also called been run at pilot scale only. They are not recycled” already are available on the organic recycling). yet viable commercially (15, 16). As for Reusing SU Products established bioprocess can be a waste and cost. Standardization reduces Reuse buffer/media mixers for consecutive significant burden, and changes always waste from expired products and excess batches of the same solution provided that come with risk. Therefore, using recycled packaging. When the same product is doing so does not exceed the maximum materials in packaging probably is the used for multiple applications, limited bioburden limit or the manufacturer’s life best short-term implementation scannable stock-keeping unit (SKU) expectancy for moving parts. opportunity for SU manufacturers. barcodes, safety stock, and bulk Top-off of buffer/media bags when they are packaging all contribute to efficient and completely drained rather using a new bag Circularity at Point of Use sustainable operations. as long as the maximum bioburden limit is The principles of circularity should be SU suppliers qualify their products not exceeded. applied across an entire for one use. However, some users might Reuse buffer bags for collecting liquid waste. biomanufacturing process, with a number be able to validate reuse of certain of strategies available. In particular, a products. The “Reusing SU Products” Reuse inlet air/gas and exhaust/vent filters significant number of “reduce” and box suggests applications that could for mixer and storage bags. “reuse” opportunities arise in different improve operational efficiency and Reuse chromatography wetted paths and stages. A monoclonal antibody (MAb) waste minimization by reuse of SU prepacked columns following end-of-batch process using a SU manufacturing train components and systems. flushing with a suitable sanitization and at 2,000-L bioreactor scale can produce as Reduce Consumption of SU storage chemical agent. much as 1.5–2.0 metric tons of plastic Components: Aside from those reuse Reuse tangential-flow filtration (TFF) wetted waste per 14-day batch (2). Below are opportunities, the biopharmaceutical paths and membranes following end-of- some examples to illustrate how to reduce industry is evolving to incorporate batch flushing with a suitable sanitization and the amount of SU waste for disposal per continuous-processing approaches that storage chemical agent. batch. could help it achieve sustainability and Reuse polymeric pinch clamps, tri-clamps, Reduce and Reuse SUT Waste: Both improve process efficiencies. Intensified and other parts that do not come into end-users and suppliers can play a part bioprocessing methods such as contact with a product stream. in SU waste reduction. Suppliers can use continuous, integrated operations in engineered packaging to reduce the smaller facility footprints could provide a Adapt contactless instrumentation for, e.g., mass of films and cardboard, and they way to reduce plastics use and thus temperature, pressure, flow, and leveling. should strive to remove unnecessary improve a company’s environmental layers (e.g., overbag films and foams) in footprint. A fully continuous system the integration of recycled polymers into secondary packaging. That would reduce would integrate upstream and SU systems, technical opportunities the amount of material consumed and downstream processes seamlessly to exist for integrating biosourced polymers save on transport fuel, storage space/ generate a constant flow of product. The into biopharmaceutical SU products and handling requirements, and discard/ advantages of integrated bioprocessing packaging. More effort is needed to disposal activities. End users can with minimal unit operations would be explore the potential for putting recycled discard fewer expired, unused materials to decrease manual handling, improve content — whether biosourced or by validating extended shelf lives and safety, shorten processing times, and traditional — into SU technologies. The applying proper inventory management, increase efficiency. Those efficiencies portfolio will be limited until it has been such as first-in–first-out (FIFO) would increase the amount of total demonstrated that all technical accounting. Users also can reduce the product being processed, giving requirements can be fulfilled. amount of unused material by manufacturing plants a reduced Economic Considerations: Because of implementing appropriate rejection ecological footprint overall and providing the current low cost of oil, recycled and standards to accept more functional for a favorable sustainability impact. biosourced polymers today are more material; through proper handling One example is perfusion processing. expensive than those based on virgin procedures on the operations floor (e.g., Using process-intensification material originating from a fossil-fuel using appropriate cutting tools for methodologies has increased cell titers feedstock. Without other prioritization, secondary packaging to prevent and help to reduce the amount of media that presents a significant barrier to damaging product bags); and by using and buffers used, effectively making adoption of alternatively sourced optimal component design (e.g., tubing more product with less raw material. materials in SU systems and other lengths) and specifications to prevent Shortened cell-expansion times improve applications. Integration of biosourced errant manufacturing. manufacturing networks and overall and recycled materials often must be Finally, users are encouraged to manufacturing timelines. Time savings coupled with a product or packaging include environmental sustainability- also lower the cost of utilities such as redesign to offset the raw-material cost based evaluation of their assembly electricity, thereby reducing process increase. This presents an opportunity to designs. Removal of extra features such energy demands and fossil-fuel “rethink” product design, but new as unnecessary sampling ports could consumption for generating power. A designs and new materials require save on material, cost, and waste — standard, batch-mode cell culture process change-control and validation work by making certain that the possibility of can take three to four weeks to run, users. Validating any change to an needing “extra” features is worth the whereas an intensified process can

24 BioProcess International 19(1–2) January–February 2021 produce more material in less time improved operational technologies that 10 Goldsberry C. Consumers Confused By (typically under three weeks). will limit further the impact of these Distinction Between Biobased and Biodegradable Plastics. Plastics Today 8 Shortened process times would materials on the environment. The social February 2020; https://www.plasticstoday. lessen the amount of energy used in benefits of SU technology currently com/sustainability/consumers-confused- heating, ventilation, and air overwhelm its residual environmental distinction-between-biobased-and- conditioning (HVAC) systems as well. risks, and BPSA will keep working to biodegradable-plastics/5040526662379. Those used to control air quality of the reduce those risks further. SU technology 11 Malloy RA. Plastic Part Design for process environment can consume more is a good choice now, and through these Injection Molding: An Introduction. Second Edition. Hanser Publications: Cincinnati, OH, energy than any other system in a efforts, will become an even better option April 2010. manufacturing plant. Decreasing in the future. 12 ASTM D7611/D7611M-20. Standard process times enables bioprocessors to Practice for Coding Plastic Manufactured make more product — or users can References Articles for Resin Identification. ASTM reduce facility airflow during extended 1 Barbaroux M, et al. The Green International: West Conshohocken, PA, 2020; downtimes and process-changeover Imperative: Part One — Life-Cycle Assessment http://www.astm.org/cgi-bin/resolver. and Sustainability for Single-Use Technologies cgi?D7611D7611M. periods. One benefit of using SU (closed) in the Biopharmaceutical Industry. BioProcess 13 Simon JM, Martin S. El Dorado of systems is that they allow cleanrooms to Int. 18(6) 2020: 12–19; https://bioprocessintl. Chemical Recycling: State of Play and Policy operate at lower classification levels, com/manufacturing/single-use/the-green- Challenges. Zero Waste Europe: Brussels, which provides operational savings. imperative-part-one-life-cycle-assessment- Belgium, August 2019; https:// Those savings and sustainability postuse-processing-and-sustainability-for- circulareconomy.europa.eu/platform/sites/ single-use-technologies-in-the- benefits are compounded further when default/files/2019_08_29_zwe_study_ biopharmaceutical-industry. chemical_recycling.pdf. process time is reduced. 2 The New Plastics Economy: Rethinking 14 Wagner M. A Circular Economy for Although the intent is to reduce the the Future of Plastics. Neufeld L, et al., Eds. Plastics: Insights from Research and Innovation costs of biomanufacturing by decreasing World Economic Forum: Geneva, Switzerland, to Inform Policy and Funding Decisions. De downtime between production lots and January 2016; http://www3.weforum.org/ Smet M, Linder M, Eds. European Commission: consequently raising productivity, docs/WEF_The_New_Plastics_Economy.pdf. Brussels, Belgium, 2019. continuous manufacturing has the added 3 Smalley M. European Governments, 15 Consortium to Support World’s First Companies Sign European Plastics Pact. benefit of lowering the number of SU Enzymatic Technology for Plastics Recycling. Recycling Today 9 March 2020; https://www. Packaging Europe 8 May 2019; https:// items and equipment required. That can recyclingtoday.com/article/european- packagingeurope.com/to-support-the-world’s- reduce end-of-life waste when drug governments-companies-sign-plastics-pact- first-enzymatic-technology-for-the-re. recycling-sustainability-2025-goals. products are manufactured using 16 Magnin A, et al. Enzymatic Recycling continuous operations. 4 GVR-1-68038-823-7. Medical Plastics of Thermoplastic Polyurethanes: Synergistic Market Size, Share, and Trends Analysis Effect of an Esterase and an Amidase and Report By Application (Medical Components, Circling Back Recovery of Building Blocks. Waste Manag. Wound Care, Cleanroom Supplies, BioPharm 85, 15 February 2019: 141–150; https://doi. The new plastic economy movement and Devices, Mobility Aids, Tooth Implants), By org/10.1016/j.wasman.2018.12.024. commitments to a circular economy Region, and Segment Forecasts, 2020–2027. c from the consumer goods and food Grand View Research: San Francisco, CA, industries have created momentum in June 2020; https://www.grandviewresearch. Magali Barbaroux is a corporate research fellow com/industry-analysis/medical-plastics- the plastics industry, with many at Sartorius Stedim Biotech; Brian Horowski is market. director of process technologies at Wood Life innovation efforts focused on 5 Health-Care Waste. World Health Sciences; Sade Mokuolu is strategy sustainability. That momentum is Organization: Geneva, Switzerland, 8 implementation manager at Watson-Marlow Fluid raising opportunities for enhancing the February 2018; https://www.who.int/news- Technology Group (a Spirax-Sarco Engineering sustainability of SU products used in room/fact-sheets/detail/health-care-waste. company); Mark Petrich is both director of single- biomanufacturing. BPSA member 6 Single Use User Requirement Toolkit. use engineering at Merck and first vice-chair of the Bio-Process Systems Alliance (BPSA); and Mitchell companies are considering these Bio-Process Systems Alliance: Arlington, VA, 2017; https://bpsalliance.org/suur-resources. Snyder is applications engineering manager at opportunities carefully, along with 7 Delaunay L, et al. How to Design and Saint-Gobain Bioprocess Solutions. Corresponding examples from other industries, to Qualify an Improved Film for Storage and author and BPI editorial advisor William Whitford improve the positive environmental Bioreactor Bags. Eibl R, Eibl D, Eds. John is life science strategic solutions leader for DPS impact of SU technology for Wiley & Sons: Hoboken, NJ, 26 July 2019; Group in Logan, UT; william.whitford@ dpsgroupglobal.com. This paper represents bioprocesses. We encourage everyone https://doi.org/10.1002/9781119477891.ch19. conclusions of the BPSA sustainability 8 Hammond M, et al. Identification of a involved with SU technology to work subcommittee and not necessarily specific Leachable Compound Detrimental to Cell toward the goal of a circular economy. viewpoints of the companies represented by its Growth in Single-Use Bioprocess Containers. members. SU material suppliers, integrators, and PDA J. Pharm. Sci. Tech. 67(2) 2013: 123–134; users increasingly are committed to https://doi.org/10.5731/pdajpst.2013.00905. sustainability as good social and business 9 Jurkiewicz E, et al. Verification of a To share this in PDF or professionally printed practice — which includes responsible New Biocompatible Single-Use Film format, contact Jill Kaletha: jkaletha@ management of used materials. BPSA Formulation with Optimized Additive Content mossbergco.com, 1-574-347-4211. endorses the study of SU sustainability for Multiple Bioprocess Applications. Biotechnol. Progr. Early View 30 May 2014; along with implementation of new and https://doi.org/10.1002/btpr.1934.

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