Biopharmaceutical firms that apply single-use technology aren’t litterbugs. Still, they may mismanage the disposal of single-use components. If so, the firms may run afoul of environmental and safety regulations. They may also miss out on recycling opportunities, which are seldom waiting to be picked up. Instead, recycling options must often be created. At the least, biopharmaceutical firms must arrange for waste to be sent to landfills or incinerators.
Disposal issues are important, but they aren’t lessening the appeal of single-use platforms. Even as waste streams swell, these platforms offer many benefits that more than compensate for any waste management burden. These platforms are generally cheaper and easier to assemble and occupy less space than stainless-steel systems. No wonder, then, that the adoption of single-use platforms is increasing, particularly in downstream processing.
“Starting around 2014, single-use began to emerge rapidly as the go-to platform in the downstream production of precision medicines—custom therapies targeted at smaller patient populations,” says Kevin D. Ott, executive director of the Bio-Process Systems Alliance (BPSA). “This was a necessary performance-driven and needs-based shift.” Large-scale facilities that relied on stainless-steel platforms and manufactured blockbuster drugs began to be supplanted by smaller facilities—low-capital-cost “flexible facilities”—enabled by single-use platforms.
Throwaways add to productivity
Single-use technology is known to provide many benefits, but it is defined by just one of them: the obviation of cleaning and sterilization procedures. Throwing away single-use components, rather than cleaning reusable components, helps biopharmaceutical companies save time and water.
A variety of single-use components and systems—tubing, connectors, bags, and custom bioreactors—are applied by Lonza. Elke Ottenschlaeger, the company’s global head of technology transfer, says customers’ productivity demands drive adoption.
“At some scales of production, there is a financial opportunity with single-use items, as they allow quick changeovers between lots and therefore help to increase utilization time,” he explains. “Single-use systems can also reduce water consumption due to reduced cleaning. For example, at our site in Slough, U.K., water consumption can be reduced by as much as 35% annually.”
A clean break from cleaning
In biopharma, cleaning is key to ensuring product quality and regulatory compliance.1 But cleaning takes time and uses expensive agents, impacting productivity. The desire to cut cleaning steps is connected to the growing popularity of single-use technology, says Rick Stock, PhD, a consultant at BDO USA, which recently acquired BioProcess Technology Consultants.
“The time it takes to turn stainless-steel equipment around for the next batch is significant compared to replacing and setting up single-use components,” Stock explains. “This is especially true if the manufacturing facility is not running three shifts/day.”
Cleaning stainless-steel equipment can take up to two weeks, while a single-use suite can be production-ready in days. “Obviously, there are labor, materials, and energy savings,” he continues, “but often production managers are more interested in the time savings which can lead to getting extra batches completed in a year, thus increasing the capacity of the facility.”
Another benefit of single-use technology, Stock points out, is the elimination of cleaning validation, the verification that equipment is fit for use after it has been cleaned. “Validation for the single-use components is almost entirely dependent on the supplier,” insists Stock. “These are supposed to be ready for manufacturing.”
Reducing downtime
According to Ott, the key benefit of a disposable manufacturing system is the reduction in facility downtime. “The beauty of single-use is that it eliminates complex and costly steam-in-place (SIP) and clean-in-place (CIP) processes, which are large consumers of employee time, distilled water, and energy.” Savings can also be realized by avoiding sterility certification, which would otherwise occur prior to batch changeover. “The end result,” Ott maintains, “is decreased risk and enhanced productivity.”
Getting in the mix
Disposing of single-use devices is a complex process, says Andrew Bulpin, PhD, head of process solutions at MilliporeSigma. “The major challenge to recycling any of these devices is due to the variety of mixed materials and different types of plastic, which are difficult to separate out from the device itself,” he explains. “The current recycling infrastructure is unable to separate and sort the plastics.”
Separating the plastics is important because their disposal methods differ. Silicon tubing, for example, does not melt in conditions used to degrade thermoset plastics.
The scale of the disposal challenge looks set to increase as single-use systems become more prevalent. “The growth of single-use brings to mind the environmental impact that comes with this trend,” Bulpin notes. “Globally, we estimate that 30,000 tons of biopharma single-use products are disposed to landfill or incineration every year.”
Looking for guidance
Disposal issues have attracted the notice of the Bio-Process Systems Alliance, an alliance of businesses and educational institutions that advocates the use of single-use manufacturing technology. “Industry is acutely aware of the need to find solutions for our own disposal challenges in the context of sustainable practices,” says Ott. “My organization is currently working on a 2019 Disposal Guide for Single-Use Systems to assist the industry.”
The pressure to dispose of plastic single-use components is considerable, and the pressure is rising, in part, due to increases in the volume of material that occur as more companies take advantage of single-use technology. Another factor, Ott points out, is expanding public concern about the environmental impact of plastic waste.
“Obviously, the current climate and publicity around controlling the spread of generic single-use plastics in the context of drinking straws, disposable razors, water bottles, etc., is not lost on our industry,” Ott states. “We are working diligently to ensure that we are not part of the problem, but part of the solution.”
Emerging solutions
One solution to the disposal problem is recycling. “Bioburdened end-of-life single-use elements are normally difficult to repurpose,” says Ott, “although there are companies that sterilize and shred such waste on a large scale, which can be used as ‘down-engineered’ feedstock.”
Recycling is a priority at MilliporeSigma. To develop a recycling program, the life sciences company has partnered with Triumvirate Environmental. The firms are working together to turn single-use plastics into industrial-grade lumber that can be used in the landscape, construction, and transportation industries.
“This program has been operating since 2015,” says Bulpin. “It has recycled approximately 22% of the waste generated by all single-use facilities along the East Coast. There are 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.”
Triumvirate’s expertise is key, according to Bulpin: “We knew from the start that to provide a recycling service for a waste stream as challenging as single-use technologies, we needed to collaborate with a trusted partner.” MilliporeSigma also knew that each customer site would require unique services that could be customized to its specific needs.
“The program is designed so Triumvirate works directly with the customers,” Bulpin notes. “As MilliporeSigma is committed to reducing environmental impact, we do pay a fee to help offset the costs of the recycling process.”
Companies signed up to the program save money. “Many of the customers using this program have been able to decrease their overall waste costs,” Bulpin tells GEN. “One area where we see a major reduction in cost would be that the waste no longer needs to be autoclaved before being sent to landfill or incineration.”
A similar approach is being followed by U.S. drug company Bristol Myers-Squibb (BMS). The firm and a partner recycle all the single-use systems used at its plant in Devens, MA. BMS says that it has recycled 400 tons of single-use plastic at the site since 2017.2
Recycling challenges
When disposing of single-use systems, Lonza takes a structured approach. “The waste is segregated into biological waste if it has come into contact with biological material or nonhazardous waste,” says Ottenschlaeger. “All biological waste must be disposed of via high-temperature incineration, and nonhazardous waste is disposed of primarily via waste-to-energy incineration.”
Lonza is making significant efforts to reduce the amount of waste that is going into landfill. The company also focuses on recycling and recovery of energy by incineration. However, for single-use systems, there are challenges.
“Recycling can be used only for non-product-contact materials,” Ottenschlaeger points out, “whereas materials that have been in contact with products or components thereof often require incineration per regulations.” Nevertheless, Lonza tries to dispose of single-use systems in an efficient way. For example, energy generated at the incineration facility at its site in Visp, Switzerland, is reused.
References
1. U.S. Food and Drug Administration. Code of Federal Regulations Title 21. April 1, 2018.
2. Morrow, KW. Addressing Challenges Posed by the Adoption of Single-Use Systems. GEN. March 12, 2019.
