How single-use technologies are shaping tubing choices in biopharmaceutical manufacturing

Editor's Note: This article originally appeared in the August 2025 print edition of Today's Medical Developments under the headline “How tubing choices are evolving”.

Innovative treatments for chronic diseases. Cancer, cell, and gene therapies. Monoclonal antibodies. Vaccines.

These are just some of the new, life-saving treatments coming out of today’s biopharmaceutical manufacturing space. And to stay ahead, reliable production strategies are non-negotiable.

In these applications, manufacturers are increasingly deploying single-use technologies (SUTs) to improve production efficiency and reliability. Some of these tools include bioreactors, mixing systems, filtration units, and tubing. SUTs can help reduce the risk of cross contamination between new batches of products, eliminate time-consuming sterilization procedures, improve turnaround times, and more. Further, high-quality SUTs can improve a facility’s flexibility and scalability, enabling manufacturers to deliver different products and batch sizes without major new investment in stainless steel equipment.

Specifically, tubing represents one of the most critical components for single-use systems, enabling effective fluid transfer throughout the production process. But not all tubing delivers quality and cost-optimization benefits that can impact your operations. What’s more, single-use parts can create issues with long-term sustainability.

This article will explore some of the common challenges faced by today’s biopharmaceutical manufacturers and how the right single-use tubing technology can help overcome them. We’ll also look at ways to evaluate your tubing options to best meet your needs, including how to make a more sustainable choice.

The benefits of single-use tubing in bioprocessing

As biopharmaceuticals have grown, the need for faster production, efficient scaling, and other new requirements has become apparent. Traditional stainless-steel components for fluid transfer in bioprocessing are showing their limitations, and SUTs have begun to displace them in critical applications.

The benefits of SUTs are clear:

Reduced contamination risk. By design and intent, single-use elastomer tubing is discarded after each use. This reduces contamination risks, which is especially important in handling sensitive biologics.

Stainless-steel fluid transfer systems, by contrast, require cleaning and sterilizing after each product run. Even under the most stringent sanitation protocols, these systems still have higher potential for contamination from residual product or cleaning agents versus if the tube was simply discarded and replaced. Further, stainless-steel systems cost extra money when they experience downtime for cleaning, validation, and sterilization, which is eliminated with single-use tubing. Removing these procedures shortens turnaround time between batches, allowing bioprocessors to stay nimble.

Enhanced operational flexibility. Because single-use tubing can be quickly adapted for various process scaling or product types without extensive downtime, it can also more effectively facilitate modular production setups. These are often necessary as production demands shift or if the processor needs to scale rapidly.

In comparison, the rigid installation and validation required for stainless steel can limit a manufacturer’s flexibility in producing new drugs with existing infrastructure. Initial capital expenditure for fixed stainless-steel equipment is also much higher than the upfront investment needed for single-use elastomeric tubing assemblies.

Choosing the right material

Specifying the right materials for single-use tubing is an important part of process design. Two materials are commonly employed for biopharmaceutical tubing: thermoplastic elastomer (TPE) and silicone.

Both materials have a reliable track record of delivering performance in these applications. Silicone, however, has an extended history in demanding medical applications and is often specified as the default choice. But both materials bring their own advantages and considerations depending upon the specific use case, and it’s worth diving deeper into each material.

Silicone provides:

• Excellent chemical inertness. Silicone is unlikely to negatively interact with the substances it transports. This is a necessary characteristic for any biopharmaceutical tubing material, but silicone specifically excels in applications involving highly aggressive chemicals or solvents.
• Advanced temperature resistance. Silicone will maintain its integrity and flexibility at extreme temperatures, making it suitable for specialized applications.
• Outstanding biocompatibility. Silicone tubing is often used in highly sensitive medical and pharmaceutical applications for this reason. However, high-quality TPE maintains good biocompatibility performance and is suitable for many bioprocessing applications.
• Superior longevity. Silicone tubing generally has the capability to maintain a longer lifespan than TPE tubing. However, when considering silicone for single-use applications, this quality is not always necessary. A silicone tube may outlive a production run, providing no additional benefit in the application.

TPE provides:

• Enhanced flexibility and adaptability. TPE tubing’s exceptional flexibility makes it ideal for applications where tight bends and maneuverability are necessary. This helps the material integrate well into complex bioprocessing systems.
• Optimal biocompatibility. High-quality TPE tubing is formulated to meet strict biocompatibility requirements, ensuring it doesn’t introduce external contaminants or affect the quality of biopharmaceutical products. This makes it an excellent option for handling sensitive biologics and pharmaceuticals.
• User-friendliness. TPE tubing is joined together via a simple thermal welding process. By contrast, silicone is joined mechanically using a barb, adhesive, tapes, and sealants. Here, TPE provides an easier installation process, enabling greater customization on the floor by allowing technicians to make quick changes as needed.
• Cost efficiencies. All single-use tubing can help bioprocessors optimize costs compared to traditional steels. But TPE tubing typically offers a cost advantage over silicone. This makes it an attractive choice for general bioprocessing applications.

For bioprocessors, material choice truly depends on the needs of the application. Exceptionally demanding applications will dictate the use of silicone. But TPE options may be worth consideration in most non-niche applications to reduce overall production costs without sacrificing processing performance.

Sustainability considerations for single-use tubing

Understandably, by their nature, SUTs raise some questions around sustainability and eco-friendliness. But think about the bigger picture.

Reduced use of energy-intensive cleaning procedures and associated water, chemicals, and sterilization agents may result in a smaller environmental footprint over a full life cycle. Additionally, SUT options are available that improve sustainability profiles. For example, many TPE products are engineered from a styrene-ethylene-butylene-styrene (SEBS) polymer as well as mineral oil for pliability and softness. Some TPE tubing is engineered by substituting a more sustainable bio-based carbon for the mineral oil component. These materials often use palm leaf oils from fallen trees instead of from living trees harvested for the oil.

Further assessment of TPE tubing for biopharmaceutical processes

If TPE is deemed a good choice for a bioprocessing application, the next step is considering all the varieties available. Choosing tubing from a reliable extruder with experience in demanding medical and bioprocessing applications helps to ensure the best result for your needs. Attributes to look for in TPE options include:

• Elevated performance. Purity is vital for bioprocessing. TPE tubing should be carefully formulated to minimize the risk of leachables and extractables, reducing the risk of contamination throughout the production process.
• Enhanced pump life. Peristaltic pumps are typical in biopharmaceutical applications. High-performance TPE tubing should resist wear, spallation, and premature degradation from pump operation, helping to extend pump life over the course of a production run.
• High burst strength. Tubing’s ability to withstand normal operational conditions is essential to maintain uninterrupted processes and prevent costly downtime. Here, TPE tubing should demonstrate exceptional burst strength, proving its ability to withstand the regular stresses and pressures encountered during fluid transfer.
• Chemical resistance. Chemical resistance enables TPE tubing to withstand exposure to potent pharmaceutical compounds. Again, while silicone is ideal for extreme applications, high-quality TPE tubing should be up to the demands of general processing conditions, maintaining structural integrity throughout a typical production run.
• High gamma sterilization capability. Optimal TPE tubing should withstand gamma sterilization levels of up to 60kGy for a duration of 30 minutes, which is reflective of typical maximum conditions in the biopharmaceutical sterilization process. This level of performance is suitable for a wide range of sterilization treatments to meet stringent requirements.

As demand for new and innovative biologics grows, bioprocessors must stay nimble and adaptable. Taking advantage of evolving tubing options is one way to do it, and it’s worth the time and effort to evaluate the choices. With today’s advanced SUTs, high-quality TPE can bring significant value and benefits in many applications.

Kent Elastomer Products
http://www.kentelastomer.com

About the author: Brian Lipowski is director of quality, regulatory and technical services for Kent Elastomer Products. Contact him at BLipowski@kentelastomer.com.