The Single-Use Revolution and Its Limits
Single-use technologies (SUT) have reshaped biopharmaceutical manufacturing over the past two decades by reducing capital requirements, compressing facility timelines, and giving manufacturers unprecedented flexibility. They have enabled the rapid pivoting between products that today’s multiproduct facilities demand. But as adoption becomes nearly universal, new questions arise: What happens when single-use systems are applied in continuous or extended campaigns? How do we reconcile the cost and environmental impact of discarding flow kits after every run? And is it time to design “single-use” systems with campaign reuse in mind?
From Batch to Campaign Thinking
Originally, single-use equipment was adopted to enable small-batch facilities to switch campaigns quickly with minimal downtime and without the burden of cleaning validation. The assumption was straightforward: after a batch—or sometimes a single day—the entire fluid path would be discarded and replaced with a sterile new assembly.
That approach still works well for clinical manufacturing or short production runs. However, as bioprocessing shifts toward perfusion, continuous downstream operations, and longer commercial campaigns, the economics are changing. Replacing a full flow kit every day or batch can quickly dominate consumables costs. The environmental burden is also significant. ISPE’s Pharmaceutical Engineering articles have highlighted the mounting volumes of single-use plastic waste and called for better end-of-life strategies, including reuse and recycling where feasible. Recent industry commentary echoes these concerns, emphasizing that environmental accountability is becoming central to the future of SUTs (Pharmaceutical Manufacturer, 2025).
Technical Enablers for Campaign Reuse
These pressures are driving a push for longer-life assemblies designed to last the duration of a campaign—days, weeks, or even months—with appropriate sanitization and integrity testing between runs.
In tangential flow filtration (TFF), many manufacturers already extend filter life by storing cassettes in sodium hydroxide between uses and performing integrity tests before restarting. Peristaltic pump tubing has advanced significantly, with materials such as Watson-Marlow’s PureWeld XL and GORE STA-PURE capable of hundreds of hours of operation, making campaign-length use achievable. Instrumentation is following suit: reusable sensor housings with disposable inserts, such as PSG Biotech’s SumoFlo single-use Coriolis flow bodies, reduce per-batch costs by allowing expensive electronics to stay in place. Inline refractometers like Vaisala’s Polaris similarly use reusable sanitary housings, with only the liner or gasket treated as consumables. These developments point to a future where “single-use” no longer implies full kit disposal after every run.
Validating Reuse Without Compromise
Campaign reuse is not simply a matter of leaving the kit on the skid. It requires validation. Manufacturers must demonstrate that cleaning or sanitization between batches is effective, that materials are chemically compatible with agents like NaOH, and that no carryover or extractables exceed acceptable limits. ISPE’s Good Practice Guide: Single-Use Technology provides a framework for assessing component compatibility and validating lifecycle use.
In practice, manufacturers pursuing campaign reuse typically perform a combination of bioburden and endotoxin testing, filter integrity checks, and visual inspections to confirm continued suitability. These same practices have long been used for reusing TFF filters and are now being extended to entire flow kits.
The Economic and Environmental Case
The case for extended-life single-use kits is not just technical; it is economic and environmental. Reducing kit replacement lowers direct consumables spend and indirect costs such as waste disposal and changeover labor. Environmentally, the benefits are clear: fewer plastics sent to incineration or landfill and less packaging waste.
A 2024 ISPE survey on end-of-life management found that many end users want suppliers to design assemblies for easier reuse, disassembly, or recycling—creating strong incentives for OEMs to innovate. Broader studies on sustainability in biomanufacturing support this trend, showing that process intensification, recycling innovations, and campaign reuse can significantly strengthen the ESG profile of biopharma operations (AIChE CEP, 2025; Frontiers in Sustainability, 2025).
The Path Forward
At Wautoma Biotech, we see this as the natural next step for single-use innovation. Designing for campaign reuse means considering material selection, modular architectures, integrated monitoring, and validated hold protocols. Systems built on these principles will allow manufacturers to run longer campaigns with confidence—lowering costs while reducing environmental burden.
Campaign reuse is not about compromising sterility or product quality; it is about aligning technology with the realities of modern biomanufacturing. As the industry shifts toward continuous processing, the economics and sustainability of “discard after one run” may no longer make sense. The future of single-use will not be defined by the number of uses, but by validated lifecycle management. This is where the industry is headed—and Wautoma Biotech is committed to designing the systems that will make it possible.
Further reading and references:
Pharmaceutical Manufacturer. (2025, August). Why the future of single-use bioprocessing depends on environmental accountability. Retrieved from https://pharmaceuticalmanufacturer.media/pharmaceutical-industry-insights/biopharma-news/why-the-future-of-single-use-bioprocessing-depends-on-enviro/
AIChE CEP. (2025, July). Toward sustainable biomanufacturing via single-use. Chemical Engineering Progress. Retrieved from https://www.aiche-cep.com
Frontiers in Sustainability. (2025). Exploring the sustainability of single-use plastics in biopharma. Frontiers in Sustainability, 3, 1536382. Retrieved from https://www.frontiersin.org/journals/sustainability/articles/10.3389/frsus.2025.1536382/