Single-Use Technology (SUT)
Advancing Biopharmaceutical Manufacturing & Bioprocessing Solutions
Engineering the Future of Biopharma with Brevet
SUT Ensures Agility & Purity in the Biopharmaceutical Industry Your Partner in Precision Single-Use Technology Solutions
Your Partner in Precision Single-Use Technology Solutions.
The landscape of biopharmaceutical manufacturing is evolving at an unprecedented pace, driven by a relentless pursuit of efficiency, safety, and speed. At the forefront of this transformation is Single-Use Technology (SUT) – a paradigm shift that is redefining how critical fluid handling and bioprocessing operations are managed. At Brevet, we are not just witnessing this revolution; we are actively engineering its components. We provide the precision-molded plastics, custom fluid path components, and single-use materials that empower the next generation of single use systems across the biopharmaceutical industry.
- Custom Fluid Path Engineering: We specialize in custom connectors, perfusion adapters, Y-connectors, straight connectors, and reducers, all meticulously designed to fit your unique fluid transfer requirements and production process needs. Our expertise extends to custom syringes for precise single use delivery and tubing assemblies for complex bioprocess applications.
- Precision Injection Molding: Our state-of-the-art plastic contract manufacturing ensures every SUT component is molded to exact specifications, guaranteeing leak-proof performance and reliable system integrity, a non-negotiable for sterile biomanufacturing.
- Made in USA: 100% American Made 🇺🇸 & Assembled
What is Single-Use Technology? Understanding SUT Systems
Single-Use Technology refers to the use of disposable components and assemblies in the bioprocessing workflow. Instead of traditional stainless steel equipment that requires rigorous cleaning, sterilization, and validation after each use, SUT utilizes pre-sterilized, ready-to-use plastic products like bioreactors, bags, tubing, sensors, filtration systems, and, crucially, custom connectors and adapters.
This innovative approach eliminates the need for complex cleaning-in-place (CIP) and sterilization-in-place (SIP) protocols, drastically reducing cycle times and production cost while improving product quality through enhanced contamination control. The implementation of single-use technology represents a shift from conventional technology to more flexible manufacturing process solutions.
Sectors Driven by Single-Use Technology Solutions
The impact of SUT extends across various critical sectors in the pharmaceutical industry:
- Biopharmaceutical Manufacturing & Therapy Production
This is the primary driver, with SUT essential for the production process of vaccines, monoclonal antibodies (mAbs), cell and gene therapies, and other complex biologics. Biopharma fluid handling relies heavily on sterile, disposable fluid paths and single-use bioreactors that reduce the risk of cross-contamination. - Medical Device Manufacturing
From cardiovascular surgery to dialysis systems and infusion therapy, single-use components ensure patient safety by guaranteeing sterility and preventing infection through disposable systems. - Laboratory & Diagnostics for Bioprocess Development
R&D labs, diagnostic kits, and research institutions increasingly leverage SUT for rapid prototyping, small-batch production, and sensitive analytical processes in both downstream process and upstream operations.
Advantages of Single-Use Technology: Benefits Driving SUT Adoption
Reduced Cross-Contamination Risk & Product Quality
Since components are disposed of after each use, the risk of contamination between different product batches is virtually eliminated, ensuring product quality and patient safety. This is a primary driver for the use of single-use systems in multi-product facilities.
Faster Batch Turnover in the Production Process
The elimination of cleaning and validation steps significantly shortens the time between production runs, leading to increased throughput and quicker time-to-market for vital therapies. The implementation of SUT accelerates the manufacturing process considerably.
Lower Operating Costs & Production Cost
SUT reduces expenses related to water, energy use, cleaning agents, and validation labor compared to reusable stainless steel equipment. Companies can also use single use technology to avoid capital investment in fixed stainless steel components.
Enhanced Production Flexibility
Single use systems allow for rapid reconfiguration and scalability, making them ideal for multi-product facilities and fast-changing market demands. The use of multiple single-use configurations supports agile biomanufacturing.
Simplified Validation & Good Manufacturing Practice
The inherent disposability simplifies regulatory compliance by minimizing re-validation efforts, supporting good manufacturing practice across biopharmaceutical operations.
The Future is Single-Use! Technology Innovation with Brevet Leading the Way
The trajectory of Single-Use Technology points to continued growth, with a focus on larger-scale applications, greater automation, and seamless integration into smart manufacturing environments aligned with good manufacturing practice (GMP) standards. As the biopharmaceutical industry evolves, Brevet remains your steadfast supplier and partner, providing the cutting-edge precision plastic components and SUT systems that make the future of biopharma a reality.
SUTs will continue to transform biomanufacturing as biopharmaceutical manufacturers recognize the benefits of single-use technology over conventional process technology. The development of SUT continues to address the limitations of single-use technology while maximizing the advantages of single-use systems.
Ready to optimize your bioprocess with custom, compliant single-use solutions? Contact Brevet today to discuss your project and discover our unparalleled expertise in fluid path components engineering.
Our expertise in precision injection molding and a wide range of thermoplastic single-use materials—including polycarbonate, PVC, and other specialized polymers—ensures that your custom fluid component is not only dimensionally accurate but also chemically compatible with your manufacturing process and functionally superior. We understand materials of construction and compatibility requirements critical to sut use.
The Material Science Behind SUT: Why Single-Use Materials Matter
Considerations for Single-Use Technology & Materials Selection
The success of Single-Use Technology hinges on the advanced materials of construction from which its components are made. At Brevet, our expertise in medical-grade plastics and understanding of extractables and leachables ensures we deliver superior performance for use technology applications:
Biocompatible Polymers for Biopharmaceutical Applications
We utilize materials like USP Class VI-compliant polycarbonate and PVC, ensuring they are non-reactive with biological fluids and won’t leach into the fluid path. Our single-use materials meet stringent safety standards for patient contact and comply with good manufacturing requirements.
Sterilizability for Single-Use Products
Our chosen single-use materials can withstand common sterilization methods (e.g., gamma irradiation, EtO) without degradation, guaranteeing a sterile SUT product upon delivery, critical for biopharmaceutical manufacturing.
Chemical Resistance & Compatibility
SUT components must resist a wide range of chemicals used in bioprocessing, from media and buffers to purification agents used in downstream process operations. We ensure complete compatibility across your unit operation needs.
Frequently Asked Questions
Single-Use Technology (SUT) Solutions
The advantages of single-use technology over traditional reusable stainless steel equipment are substantial. SUT eliminates the need for complex cleaning and sterilization validation, dramatically reducing the production cost and time between batches. Single use systems reduce the risk of cross-contamination, which is critical for product quality in multi-product facilities. The benefits of single-use include lower capital investment (no expensive stainless steel components), reduced energy use and water consumption, faster facility setup, and greater production flexibility. The implementation of single-use technology also simplifies compliance with good manufacturing practice requirements by minimizing revalidation efforts between production runs.
The limitations of single-use technology primarily include environmental impact from plastic waste generation, potential supply chain dependencies on supplier reliability, size limitations for very large-scale operations (though many single-use applications now support commercial scale), and the need for careful evaluation of extractables and leachables to ensure materials won’t leach into the fluid path and affect product quality. The life cycle assessment should balance operational benefits against waste considerations. Additionally, while SUT reduces certain validation requirements, proper process design and compatibility testing are essential when selecting the right single-use components for your specific bioprocess. Considerations for single-use implementation should include total cost of ownership, environmental impact, and long-term supplier partnerships.
Brevet ensures compatibility and quality through rigorous material selection and testing protocols. Our single-use materials are USP Class VI-compliant and tested for extractables and leachables to ensure they won’t leach into the fluid or compromise product quality. We work closely with biopharmaceutical manufacturers to understand their specific materials of construction requirements, process design needs, and unit operation specifications. Every SUT component undergoes dimensional verification and functional testing to ensure compatibility with existing systems, whether for bioreactor applications, filtration systems, or downstream process operations. Our quality management system aligns with good manufacturing practice and supports the implementation of single-use technology with full documentation and traceability.
The use of SUT has expanded dramatically across biopharmaceutical manufacturing, and SUT is used in an increasingly wide range of applications. While single-use bioreactors, tubing assemblies, filtration systems, and fluid handling components are well-established, the implementation of single-use technology continues to expand into new unit operation areas. Many single-use solutions now exist for both upstream and downstream process operations. However, certain very large-scale commercial processes may still utilize stainless steel equipment for primary vessels while incorporating single use components in auxiliary systems. A manager for single use technology implementation should evaluate each unit operation individually. The development of SUT continues to address previous limitations, and SUT will continue to grow as technology innovation expands capabilities. Companies can also use hybrid approaches combining reusable equipment with single-use components where appropriate.
Brevet serves as a specialized supplier of precision-engineered SUT components and fluid path components for the biopharmaceutical industry. We manufacture custom connectors, adapters, tubing assemblies, and single-use products that are critical to SUT systems across biomanufacturing operations. Our role extends beyond simple supplier relationships—we partner with biopharmaceutical manufacturers to design and optimize process technology for the production of biologics and therapies. We support the implementation of SUT through custom process design solutions, ensuring our materials of construction and component designs meet specific compatibility requirements. As a trusted supplier, we provide the quality assurance, documentation, and traceability needed to support good manufacturing compliance while enabling the benefits of single-use technology across bioprocessing, therapy production, and bioreactor operations.
Contract Manufacturing
Brevet is uniquely positioned to empower your transition to or expansion of Single-Use Systems. Our core strengths are perfectly aligned with SUT’s demands:
Full Compliance & Traceability: We provide comprehensive documentation, material traceability, and adhere to strict quality control, supporting your regulatory needs and providing confidence in your single-use components.