Pharmaceutical Technology - May 2019

Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2019 41 plier and the end-user. With new requirements for extractables and other testing, the time as- sociated with the assessment and qualification of changes is increasing, which makes it more challenging to manage supply risks throughout the duration of the change. Managing change is challenging in a rapidly growing market with continuous evolving guid- ance that requires a smart risk-based approach. One size does not fit all. We have extensive knowl- edge of our customers' processes so we can stra- tegically evolve their manufacturing process to fit their growth plans. References 1. F. Mirazol, BioPharm Intl. 31 (2) 33-35. 2. MilliporeSigma, "MilliporeSigma to Open China's First Mobius Single-use Manufacturing Facility in Wuxi," Press Release, Sept. 12, 2018. 3. GE Healthcare Life Sciences, "GE Healthcare Starts to Manu- facture Single-Use Consumables in China through Collabora- tion with Wego," Press Release, Nov. 7, 2018. 4. GE Healthcare, "Single-use and Sustainability," www.gelife- sciences.com/en/us/solutions/bioprocessing/knowledge-center/ single-use-and-sustainability, accessed Jan. 2, 2019. 5. BPSA, "Single-Use Manufacturing Component Quality Test Matrices," http://bpsalliance.org/technical-guides/. PT Single-use systems for biopharmaceutical manufacturing are, as their name implies, used once and then disposed of, unlike traditional, stainless-steel equipment, which is cleaned and re-used. Although single-use components might seem at first glance to be less sustainable than reusable ones, single-use systems actually have a lower environmental impact, primarily due to the high environmental impact of the high purity water and heat needed to clean and sterilize traditional systems, notes Jeff Carter, strategic project leader at GE Healthcare Life Sciences. The company performed a lifecycle assessment (LCA) study in 2016–2017 (1) as a more detailed follow-up to its 2010–2012 LCA study, and the new LCA showed that end-of-life impacts were small compared to use and supply-chain impacts. Disposal, however, is still an issue to be considered. Options include landfill, waste-to-energy (WtE) incineration, or recycling. "One should be aware that every solution to the problem has its own limitations and its own environmental impact. Waste management is complex from a societal, technological, and regulatory perspective. As such, this issue is one that demands a cooperative and collaborative effort," says Carter. The first challenge for disposal of single-use components is that components that are in contact with biological materials are classified as bio-hazardous. A user will typically treat the waste at their site by autoclave, before sending it out through local waste management vendors that will bury the waste in a landfill, says Andrew Bulpin, head of Process Solutions at MilliporeSigma. Another option is incineration with cogneration. "WtE has been an acceptable practice for many users, as it offers an efficient way to collect and dispose of the waste, while converting the energy released by the burning of the plastic to electricity and/or steam used in heating municipal resources," explains Bulpin. "However, not every region has WtE facilities near their site, and not every WtE facility will accept single-use materials if they have been classified as bio-hazardous. In some areas, such as the United States, an appropriate WtE facility can be more than 250–400 miles away, and in some regions it could be well over a thousand miles away." In Western Europe, more facilities may have access to local WtE capabilities, but recycling is being considered because of its potential benefits for contributing to reducing the use of plastics to make new products. "There are many different options available to users based on where they are located geographically and what works best for their corpo- rate culture and commitments," says Bulpin. "The solution of recycling should be contextualized into the common sustainability mantra: reduce, reuse, and recycle, in that order," suggests Carter. "Effort should first be aimed at reducing waste generation in the first place, for both the product and the packaging, as well as transportation. Reusing doesn't get a lot of traction with single-use equipment, although there is discussion of reusing pallets that are used in the transport of the equipment. Lastly, there is recycling." In addition to the biohazard classification, a significant challenge for recycling is that single-use systems used in biopharma are typically made up of different types of plastic materials that are difficult to separate. An alternative is to use the mixed plastic waste to make durable products, such as pallets and plastic boards, notes Carter, who says there is also some discus- sion of recycling the magnets used in the impellers of mixers and bioreactors. In the eastern part of the US, MilliporeSigma has partnered with Triumvirate Environmental to of fer the Biopharma Recycling Program, which allows manufacturers using single-use devices and systems to recycle the plastic into industrial-grade construction materials. "The process, which has been fully permitted to accept bio-hazardous materials, as well as other plastic- containing devices, can safely sterilize and manufacture recycled plastic lumber under one roof," says Bulpin. "This program has been operating since 2015 and has recycled approximately 22% of the waste generated by single- use facilities along the East Coast. There are currently 18 manufacturing sites using the program, and while this is the first of its kind, there is hope that this program will help to increase investigation into other technologies that can further reduce the environmental impact of single-use systems." Reference 1. GE Healthcare, "Single-use and Sustainability," www.gelifesciences.com/ en/us/solutions/bioprocessing/knowledge-center/single-use-and-sus- tainability, accessed Jan. 2, 2019. —Jennifer Markarian SUSTAINABILITY IN DISPOSAL OF SINGLE-USE SYSTEMS

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