OR WAIT null SECS
It is crucial to examine the context in which single-use waste is viewed.
As it has gained increased prominence in the public sphere, sustainability has emerged as a predominant focus among manufacturing organizations. While total waste estimates are difficult to determine for various reasons, many individual companies have taken the initiative to publicize data concerning sustainability efforts.
For instance, Roche published a data set demonstrating that, from 2007 to 2022, general waste decreased by approximately 4000 metric tons, while chemical waste decreased by 23,000 metric tons; this represents total reductions of approximately 23% and 62%, respectively (1). Other companies have done the same, even when the data are not pretty. AbbVie, for instance, revealed in a five-year report that it produced more hazardous waste in its most recent year (18,200 metric tons) than at any other point in that five-year timeframe (2). Independent of what conclusions can be drawn from waste data, publishing the data represents a commitment to transparency and future sustainability efforts.
Notably, while this is of particular importance to many in the general public, it is weighted just as much, if not so, by pharma partners. In an interview with BioPharm International®, Pierre Luzeau, CEO of Seqens, a pharmaceutical synthesis and specialty ingredients company, noted that customers were specifically looking for partners who could help them reach sustainability goals (3). Furthermore, he predicted that sustainability was rapidly becoming an exclusionary factor for companies who couldn’t keep up.
“We are convinced that the selection of suppliers will be based on the best supplier from that standpoint,” said Luzeau in the interview. “If you are not capable of proposing the best solution as far as [corporate social responsibility] is concerned, you will disappear in the ten years’ timeframe—this is for sure.”
It is in this vein that single-use technologies (SUTs) must be examined in terms of their current and future waste potential relative to comparable solutions, as it may speak volumes toward their future efficacy.
The benefits of SUT are well understood. According to Helene Pora, vice-president of Technical Communication & Regulatory Strategy at Pall, single-use systems offer a “level of flexibility, scalability, and cleanliness that is near impossible to achieve with glass and stainless-steel counterparts.” Per Pora, SUTs allow lines to be repurposed more easily, eliminate the need for cleaning and cleaning validation, save both time and money, and make the manufacturing process safer for operators (4).
The question, however, isn’t necessarily of the benefit of using SUT, rather, the question is of benefit relative to cost and how that cost benefit stacks against other cost-benefit calculations. One such calculation involves environmental impact vs. stainless-steel (or, for certain operations, glass) transport. Unfortunately for those who prefer simple answers, in terms of waste, there’s no clear better option.
SUTs are composed of plastics that need to be disposed of after use, generating plastic waste. To the untrained eye, this might lead one to believe that SUTs are going to inherently be more wasteful than stainless-steel containers. However, while stainless-steel fixtures are designed to remain in place indefinitely, in between batches they need to be cleaned using water, which generates significant water waste. In the aforementioned AbbVie report, for instance, 4.1 million cubic tons of water was consumed; the AbbVie report defined this as water that is used excluding non-contact cooling water that is drawn from and returned to the same source with equal quality.
Consequently, the amount of waste generated is dependent on the type of manufacturing that is being done at the facility. For extremely large volume-batches, this can make stainless-steel a stronger option; while one 2014 study found that single-use produced less waste in batches as large as 2000 liters (5), stainless steel experts have stated that once a manufacturer is producing more than 10 kgs per drug batch (or 3000 kgs per year) stainless steel leads to less overall waste (6).
As a result, depending on the type of operation, either stainless steel or single use could theoretically be the “more” wasteful option. For outsourcing organizations who need flexibility to produce various, small-batch operations, the requisite cleaning on stainless-steel facilities would create a larger energy burden than the disposable plastics. Conversely, if a company is producing medications on a large-scale, such as an insulin, stainless steel is the more energy-efficient option.
While SUT may be more energy efficient than stainless steel in many use cases, it is worth acknowledging that this perspective views energy expenditures agnostically. However, while the pharmaceutical industry burns plastics in a strictly controlled environment, many other industries have less rigorous processes, which has pushed plastic waste to the forefront of the public and government’s agenda.
For instance, a recent report from the United Nations Environment Programme found that there is 11 million metric tons of plastic waste entering the ocean annually, and that this number is expected to triple over the next twenty years (7). Because of known carcinogens in plastics and the downstream impact that these chemicals can have to both sea life and humans, this has placed a bullseye on plastic waste specifically; for example, in 2022 both Canada (8) and India (9) passed bans on most forms of single-use plastics.
For now, it appears that pharma has been spared the brunt of this plastics crusade, in large part because of its significant merits, but as pressure mounts to reduce plastic waste, increased scrutiny will be placed on all use cases regardless of merit. In particular, as scientists continue to study the impact of plastics in human cells (10), extractables and leachables (E&L) testing will likely endure further scrutiny in both manufacturing and packaging processes. In a scenario where all plastics are on trial, perhaps following high-profile incidents where plastic contaminants are conclusively linked to an E&L testing failure, regulatory guidelines could further tighten on E&L to assure consumers that these processes are not introducing additional carcinogens to consumers. Down the line, this could present significant challenges for manufacturers who use SUTs and do not have a robust E&L process.
In this view, perhaps the ultimate fate of SUT is tied to that of scientifically sound E&L testing. This may not necessarily mean more tests, although that is a potential avenue of change. As knowledge of the materials used and the process which cause chemical species to migrate increases, artificial intelligence that models chemical interactions may be used in lieu of traditional testing methods (11). This could present a viable alternative that allows the use of SUT to continue in its current fashion.
Putting aside the nuances of that consideration, the pharma industry must understand the tacit connotations the public places on plastics. Sustainability must not be viewed solely as an “energy in, energy out” practice, as many discussions of SUT tend to frame the dialogue, because it has inextricable ties to pollution and human health. An important context must be considered: for as long as plastics are at the forefront of environmental discussions, scrutiny surrounding SUTs will follow suit.
1. Mikulic, M. Pharmaceutical Industry: Waste Generated by Roche 2007-2022. statista.com (accessed April 10th, 2023).
2. AbbVie. 2021 Environment and Safety Performance. abbvie.com (accessed April 10th, 2023).
3. Playter, G. Setting Sustainability Goals with Pierre Luzeau. BioPharmInternational.com, March 30, 2023.
4. Playter, G. Weighing the Benefits of Single-Use Consumables. PharmTech.com, Oct. 4, 2022.
5. Flanagan, W.; Brown, A.; Pietrzykowski, M. et al. An Environmental Lifecycle Assessment of Single-Use and Conventional Process Technology: Comprehensive Environmental Impacts. BioPharm Int. 2014 27 (3).
6. Haigney, S. The Case for Stainless Steel. BioPharm Int. 2019 32 (8) .
7. UN Environmental Programme. From Pollution to Solution. Oct. 21, 2021.
8. Newburger, E Canada is Banning Single-Use Plastics, Including Grocery Bags and Straws. cnbc.com, June 21, 2022.
9. ET Online. Single-Use Plastic Banned in India from Today. Here Are Some Eco-Friendly Alternatives. economictimes.indiatimes.com, July 1, 2022.
10. ACS. Methods for Microplastics, Nanoplastics and Plastic Monomer Detection and Reporting in Human Tissues. Press Release, Aug. 17, 2020.
11. Morley, N. The Future of E&L— A world without extractable studies? chromatographyonline.com, Nov. 1, 2022.
Grant Playter is associate editor for BioPharm International.
Vol. 36, No. 5
When referring to this article, please cite it as Playter, G. Contextualizing Single-Use Waste. BioPharm International 36 (5) 2023.