Choosing the Right Sanitary Tubing for Biopharmaceutical Processes
Choosing the Right Sanitary Tubing for Biopharmaceutical Processes: Types, Pros, Cons, and Selection Tips
In biopharmaceutical manufacturing, sanitary tubing plays a foundational role in maintaining sterility, ensuring product purity, and supporting efficient fluid transfer. Because these systems often handle sensitive biological materials—cells, proteins, buffers, and high-value drug intermediates—the choice of tubing can significantly influence process reliability, regulatory compliance, and overall product quality. Several tubing materials are commonly used throughout upstream and downstream operations, each with unique strengths and trade-offs.
Common Types of Sanitary Tubing
- Silicone Tubing
Silicone remains one of the most widely used tubing materials in biotech applications. Its flexibility, biocompatibility, and broad temperature tolerance make it suitable for peristaltic pumping, media transfer, and single-use assemblies. Silicone is also easy to sterilize via autoclave, gamma irradiation, and SIP (depending on formulation).
Pros: Highly flexible, translucent for visual monitoring, compatible with most sterilization methods, very low extractables.
Cons: Lower pressure resistance, potential for spallation in peristaltic pumps, and relatively high gas permeability which may or may not be desirable depending on the application. - Thermoplastic Elastomer (TPE) Tubing
TPE tubing (such as C-Flex®, Flexelene®, or other proprietary blends) has become a staple in single-use technology. TPE can be heat-sealed and aseptically welded, enabling closed-system transfers without compromising sterility.
Pros: Aseptic welding capability, consistent mechanical strength, low extractables, compatible with gamma irradiation, and reduced spallation compared with silicone.
Cons: Less flexible than silicone, can stiffen at low temperatures, and may have narrower chemical compatibility depending on the formulation. - PTFE / PFA / Fluoropolymer Tubing
Fluoropolymers such as PTFE and PFA offer outstanding chemical resistance, making them ideal for aggressive CIP chemicals, solvents, and strong acids or bases. They also exhibit very low extractables.
Pros: Exceptional chemical compatibility, high temperature tolerance, and long service life.
Cons: Limited flexibility, not suitable for peristaltic pumps, and typically not weldable or sealable for single-use workflows. - Stainless Steel Tubing
Though not a “soft tubing,” stainless steel remains essential in fixed bioprocess equipment, especially where durability and cleanability are priorities.
Pros: Extremely robust, excellent pressure rating, long lifespan, ideal for CIP/SIP, and compatible with virtually all process chemicals.
Cons: Not suitable for flexible or disposable systems, higher installation cost, and requires orbital welding and rigorous validation.
How to Choose the Right Tubing
Start with your process requirements. Consider flow rates, pressure, temperature, and the nature of your media or intermediates. Peristaltic pumping often points to silicone or TPE; aggressive chemicals may require fluoropolymers or stainless steel.
Identify sterilization and closure needs. If you need aseptic welding to maintain a closed system, TPE is the clear choice. For repeated autoclaving or SIP cycles, silicone or stainless steel may be more appropriate.
Evaluate compatibility and extractables. Regulatory expectations are increasing, so check supplier extractables profiles, validation guides, and historical performance in bioprocess settings.
Balance flexibility with strength. Silicone is best for applications requiring handling or bending, while fluoropolymers and stainless steel suit fixed, high-integrity systems.
By understanding the strengths and limitations of each tubing type, you can select a solution that reduces risk, increases process efficiency, and supports compliant, scalable biopharmaceutical production.
