Single-Use vs. Stainless Steel Pumps: Pros and Cons
If you're running a pharmaceutical or biotech operation in the U.S., one of the biggest equipment decisions you'll face is whether to go with single-use pumps or stainless steel pumps. Both have their place. Both have real tradeoffs. This guide breaks down the pros and cons so you can pick the right pump for your process—and your bottom line.
Before we get into the comparison, let's make sure we're talking about the same things. The pharma pump world has split into two camps over the past two decades, and it's worth knowing what each side brings to the table.
Stainless steel pump solutions were traditionally used in the biotech and biopharma industries, though they posed challenges such as increasing time between use for cleaning and maintenance. These are your classic permanent, multi-use pumps—typically built from 316L stainless steel with electropolished internals, sanitary tri-clamp fittings, and full CIP/SIP (Clean-In-Place / Sterilize-In-Place) capability. They're designed to last for years, handle aggressive chemicals, and meet FDA and cGMP standards for hygienic processing. At CNP, we've been building stainless steel centrifugal pumps for over three decades, and these workhorses remain the backbone of large-scale pharma manufacturing. If you want the full picture on what it takes for pumps to meet FDA standards—material traceability, surface finish, sanitary design—our guide on meeting FDA compliance with sanitary pharmaceutical pumps covers every detail.
To overcome the cleaning and maintenance challenges of stainless steel, the industry evolved to use single-use pumps, which had disposable components—most often pump heads—that allowed users to shorten change-out times, and maintain more constant levels of sterility. Single-use (also called disposable) pumps use polymer-based, pre-sterilized components that contact the product. After one production run or batch, the wetted parts are discarded and replaced with a fresh set. Common types include single-use peristaltic pumps, quaternary diaphragm pumps, and centrifugal pump heads with disposable chambers. Single-use systems are typically made of plastic components which are later sealed and sterilized by gamma irradiation processes, and for the most part, they are meant to be utilized in the same way as their reusable counterparts.
The single-use pump market is booming. The global single-use pump market was evaluated at US$607.17 million in 2025 and is expected to attain around US$2,666.98 million by 2035, growing at a CAGR of 15.95%. North America dominated the global single-use pump market by 41%. That growth tells you the industry is moving—but it doesn't mean stainless steel is going away. Far from it. Let's dig into why.
Single-use technology has changed how pharma and biotech companies handle everything from buffer preparation to final filling. Single-use technologies are gaining momentum in pharmaceutical and biopharmaceutical manufacturing, and according to a recent BioPharm International article, adoption of single-use technology is on the rise, with one supplier reporting that up to 70% of new plants are being designed to use single-use technology. Here's what's driving that—and where the technology still falls short.
What single-use pumps do well:
The biggest sell for single-use pumps is that they slash cleaning and validation time. Single-use pumps eliminate the need for pump cleaning, sterilization, and reuse, providing significant cost savings and reducing time to market. You don't need CIP or SIP cycles between batches. You pull out the used pump chamber, pop in a new pre-sterilized one, and you're running again. Some systems, like the Quattroflow EZ-Set, allow pump chambers to be replaced in as little as 30 seconds without the need for special tools or torque wrenches.
Cross-contamination risk drops to near zero. Since the product flow path is discarded and replaced after each batch, the risk of product cross-contamination between batches of different drug substances, related to campaign changeover, is virtually eliminated. That's a huge deal for multi-product facilities and contract development and manufacturing organizations (CDMOs) switching between different drug substances on the same line.
The cost profile is also different from stainless steel. Single-use pumps typically cost less than traditional, stainless steel equipment in terms of lowered initial capital, overhead, and operating costs. You're not buying a $50,000+ stainless steel pump with piping, valves, and an entire CIP skid. You're buying a modular system with replaceable, lower-cost components. For early-phase clinical manufacturing or small-batch biologics production, single-use often wins on total cost.
Process flexibility is another strength. Single-use components like tubing come in a wide range of specifications and can be quickly and easily modified to facilitate rapid process changes, enabling manufacturing companies to remain agile and respond swiftly to evolving process demands.
Water usage drops dramatically, too. Single-use technologies can reduce water use by as much as 85% compared to a stainless steel plant, primarily because disposables don't need CIP/SIP treatment. When you consider that cleaning stainless steel manufacturing equipment is the most significant use of water in many pharmaceutical facilities, accounting for 50–70% of all water use, that 85% reduction is real money and a real sustainability win.
Where single-use pumps fall short:
Single-use isn't without its problems. Single-use technology still has a number of validation steps that need to be undertaken before adoption, including assessing any leachables or extractables that might arise when the product comes into contact with the single-use technology. Extractables and leachables—chemicals that can migrate from the plastic components into your product—are a legitimate concern. Every single-use system needs extractables testing, and if a leachable interacts with your drug substance, you've got a problem.
Scalability is another sticking point. Limits in scalability mean that single-use technology is more suited to small-scale production, and large-scale manufacturers may find it more difficult or not cost-effective to completely adopt SUT. If you're making a blockbuster monoclonal antibody at 10,000 L or 20,000 L scale, single-use can't match the throughput and economy of a dedicated stainless steel line.
Discarded equipment can add up quickly, creating significant amounts of waste that must be disposed of properly, which can be a major environmental concern, especially as the pharmaceutical industry continues to grow. Even though single-use saves water and energy during operations, the plastic waste stream is real and growing. And let's be honest—supply chain risk is a factor. The limited number of suppliers and the corresponding lack of standardization and interchangeability of materials can lead to unplanned production snarls when components are unavailable due to difficulties with the supply chain.
Finally, single-use systems can be less reliable than traditional equipment because the equipment is designed to be used only once, is not as durable as traditional equipment, and may be more prone to failure. A bag failure mid-batch can mean losing an entire production run.
Stainless steel pumps aren't going anywhere, and for good reason. For high-volume, long-campaign production—the kind that keeps large pharma plants humming—stainless steel still sets the bar.
What stainless steel pumps do well:
Durability is the standout. A well-maintained 316L stainless steel pump can run for a decade or more. Thanks to its corrosion and wear resistance, stainless steel pumps typically require less frequent maintenance than those made from cast iron or other materials. This translates to longer service intervals, fewer part replacements, and reduced downtime—resulting in lower total cost of ownership.
For pharma applications, stainless steel's hygienic properties are proven. The electropolished surface finish (Ra ≤ 0.8 µm) resists biofilm formation, the material won't leach anything into your product, and the pump can handle CIP/SIP cycles day in and day out without degrading. As we outline in our FDA compliance guide, every wetted part of an FDA-compliant pump—every gasket, seal, O-ring, and internal surface—must meet the FDA's material safety guidelines for contact with pharmaceutical products, and 316L stainless steel is the gold standard for that.
Stainless steel also handles the full range of pharma fluids—from aggressive solvents and acids to Water for Injection (WFI)—without batting an eye. SS 316L has extremely low reactivity with organic compounds, solvents, APIs, and cleaning agents, and it doesn't leach metallic ions into the fluid stream, which is critical when you're transferring drug intermediates or final formulations.
At scale, stainless steel wins on cost per batch. Though stainless steel has higher upfront cost, if you have a blockbuster drug, it could provide more long-term savings because of its durability. When your facility is dedicated to one or two high-volume products, the capital investment pays for itself many times over.
And there's no waste stream to manage—no disposal of plastic components after every batch, no ongoing polymer supply chain dependency.
Where stainless steel pumps fall short:
The upfront cost is the elephant in the room. Permanent stainless-steel process lines are expensive to install and have complex and time-consuming cleaning and validation requirements. You're not just buying a pump—you're buying the pump, the piping, the CIP skid, the SIP system, the automation and instrumentation, and the facility infrastructure to house it all.
Dedicated stainless steel processes offer fewer opportunities to increase yield or capacity beyond the system's original specifications, as they are inherently fixed after a certain point in engineering. If your product pipeline changes, if your batch sizes shift, or if you need to pivot to a different drug substance, you're looking at major re-engineering work.
Cleaning validation is time-consuming and expensive. In addition to being expensive and inflexible, stainless steel requires time-consuming clean-in-place (CIP) and sterilize-in-place (SIP) procedures, which can actually increase risk of contamination. If a CIP cycle fails or doesn't fully clean the system, you've got a batch contamination risk and a potential recall on your hands.
For multi-product facilities, product changeover on stainless steel is slower. You need to clean, validate, test, and document before you can switch to the next drug substance—adding days or weeks to your production calendar.
Here's a side-by-side look at how single-use and stainless steel pumps stack up across the factors that matter most in pharma and biotech manufacturing:
This comparison shows that neither option is universally better. The right choice depends on your production volume, product pipeline, facility setup, and how you balance capital vs. operating costs.
Unfortunately, there is neither a straightforward decision algorithm nor a simple yes-or-no answer to whether one solution should be preferred over the other.[7] That's a reality many pharma manufacturers are grappling with right now.
So how do you actually decide? Let's break it down by scenario.
Go single-use when: you're in early-phase clinical trials, running small batches (under 2,000 L), operating a multi-product CDMO facility, or working with cell and gene therapies where batch sizes are tiny and changeover speed matters. Single-use also makes sense when you want to minimize your facility footprint and avoid massive upfront capital outlays. The flexibility and scalability of single-use systems make them ideal for small-scale production and pilot studies, further driving their adoption in research and development activities.
Go stainless steel when: you're manufacturing a proven commercial product at high volume, your process is stable and dedicated, and you need pumps that can handle aggressive chemicals, high temperatures, and round-the-clock operation for years. Stainless-steel bioreactors and systems are especially relevant for certain monoclonal antibody products that depend on bulk manufacturing, and stainless steel is expected to remain in use for some time, especially for treatments for cancer, diabetes, and others in which large volume is required. If you need a reliable centrifugal or multistage pump for water boosting, process fluid transfer, or utility services in your pharma facility, check out our booster pump systems for options built to last.
Consider a hybrid approach when: you want the best of both worlds. By strategically integrating single-use technologies with stainless steel equipment in the same facility, you have the potential to unlock a high degree of configurability and speed from your single-use systems, and large-volume capacities from your stainless steel production trains. A lot of leading pharma manufacturers are going this route. Organizations are using a combination of stainless steel and single-use products to achieve the most streamlined and cost-effective manufacturing process possible.
For example, a CDMO might run single-use systems for upstream bioprocessing and clinical-phase work, while dedicating stainless steel pumps and vessels to downstream purification and commercial-scale production. This hybrid model gives you flexibility where you need it and reliability where volume demands it. A well-planned hybrid system has the potential to deliver higher long-term ROI than stainless steel or single-use systems alone.
At CNP, we focus on the stainless steel side of the equation—and we build our pumps to hold up in the most demanding pharma environments. Our smart factory in Hangzhou uses laser welding, progressive die technology, and full-process quality tracking to make sure every pump we ship meets the specs your auditors expect. Whether you're outfitting a new cleanroom line or upgrading an existing facility, we bring over three decades of pump engineering, FDA-compliant materials, and documented quality control that gives you a solid paper trail for compliance.
Can you use single-use pumps for large-scale commercial manufacturing?
In most cases, no—not yet. Limits in scalability mean that single-use technology is more suited to small-scale production. Dedicated commercial manufacturing in stainless steel still provides large volume capability for large-scale production where single use cannot. Most single-use systems top out at around 2,000 L, and while you can add more units in parallel, managing multiple disposable systems at large commercial scale gets complex and expensive.
Are single-use pumps more environmentally friendly than stainless steel?
It's not as clear-cut as you'd think. Contrary to popular belief, current evidence points towards single-use technology being an eco-friendlier alternative to steel—at least when it comes to fluid processing technology in the pharmaceutical industry. Single-use saves water (up to 85%) and energy by eliminating CIP/SIP cycles. But the plastic waste generated after every batch is a growing concern. When compared to super-heated steam cleaning, which requires energy, cleaning chemicals and large amounts of water, single-use technology is arguably no less sustainable than stainless steel technology. The honest answer is that it depends on what you measure—carbon footprint, water use, or solid waste—and what matters most to your sustainability goals.
What are the biggest risks of switching from stainless steel to single-use pumps?
The key risks include assessing any leachables or extractables that might arise when the product comes into contact with the single-use technology.[1] There's also the supply chain factor: with fewer suppliers and less standardization in single-use components, you're more exposed if a key supplier has disruptions. And implementing single-use systems reduces capital costs, but in some cases capital savings are offset by increased operating costs, meaning life-cycle costs for many single-use applications are higher than for conventional stainless steel systems.
Do stainless steel pumps meet FDA compliance for pharmaceutical use?
Yes—when they're built right. Stainless steel pumps constructed from 316L with electropolished surfaces (Ra ≤ 0.8 µm), FDA-grade elastomers, and sanitary clamp fittings meet the requirements outlined in 21 CFR Parts 210 and 211 for cGMP manufacturing. Material traceability and documentation are also part of the package. We cover this in depth in our guide on FDA compliance for sanitary pharmaceutical pumps.
Is a hybrid approach better than going all-in on one technology?
For many pharma manufacturers, yes. A hybrid strategy, where both single-use process equipment and stainless steel process equipment are used throughout development and manufacturing, can offer flexibility and the combined benefits of both processing types. You get the speed and low contamination risk of single-use for smaller or variable batches, and the proven reliability and scale of stainless steel for dedicated commercial production. The trend in the industry is clearly moving toward hybrid facilities, and the data backs up the ROI case for this blended approach.
If you're running a pharmaceutical or biotech operation in the U.S., one of the biggest equipment decisions you'll face is whether to go with single-use pumps or stainless steel pumps. Both have their place. Both have real tradeoffs. This guide breaks down the pros and cons so you can pick the right pump for your process—and your bottom line.