Single‑Use Technology
Single‑Use Technology
Single‑use technology (SUT) has become a foundational manufacturing platform for modern biopharmaceutical production, enabling flexible, modular operations for monoclonal antibodies, vaccines, and cell and gene therapies. Over the past two decades, the industry has shifted from fixed, stainless‑steel infrastructure toward disposable, often gamma‑irradiated assemblies that support rapid deployment, multi‑product manufacturing, reduced cross-contamination and cleaning and accelerated time to market.
For multi product biopharmaceutical companies operating at small to medium commercial scales or under highly dynamic demand profiles, single use facilities represent the most technically viable and operationally efficient manufacturing solution, offering scalability without the complexity and downtime associated with traditional stainless steel plants.
By eliminating the need for extensive clean‑in‑place and steam‑in‑place systems, SUT enables “ballroom” facility concepts that prioritize operational agility while maintaining full cGMP compliance. Successful implementation requires careful integration of process design, material science, logistics, and facility systems to ensure product quality, sterility assurance, and regulatory alignment from clinical through commercial scale.
Key Issues
Single‑use technology introduces distinct set technical, regulatory, operational and sustainability considerations that influence process selection, facility layout and operational strategy. Product modality — including monoclonal antibodies (mAbs), viral vectors, or cell therapies — drives expectations for contamination control, segregation, and supplier qualification. While disposable fluid paths significantly reduce cross‑contamination risk, they shift complexity toward material handling and installation, warehousing, and waste management. Polymer contact materials must be compatible with process conditions and supported by robust extractables and leachables assessments. Regulatory scrutiny continues to intensify around component traceability, system closure, supplier change control, and sterility assurance, including gamma‑irradiation validation and pre‑use integrity testing where applicable.
While disposable fluid paths introduce many advantages to the operation, they also introduce large volumes of polymer based solid waste that must be actively managed. Designers can leverage established industry best practices, where applicable, to improve sustainability performance by integrating options for waste minimization strategies. These options can include collaboration with waste handling companies with enhanced programs for sustainability or single use suppliers that offer recycling and take back programs for their products.
How Fluor Helps
Fluor brings decades of experience delivering cGMP biopharmaceutical facilities using single use process platforms, from feasibility and engineering through construction, commissioning, and qualification. Fluor has executed projects for different product modalities, integrating single use systems and supporting infrastructure to enable flexible, multi product manufacturing for facilities across Europe and the United States.
Process Features
Single‑use process systems comprise disposable bioreactors, mixers, chromatography assemblies, filtration devices, and tubing sets designed for closed or functionally closed operation. Advances in polymer engineering — including multi‑layer films with defined contact surfaces and gas barriers — enable reliable performance across a wide range of biologics applications. Single‑use sensors for pH, dissolved oxygen, and biomass support real‑time monitoring and Process Analytical Technology (PAT), enabling automation and control approaches comparable to stainless‑steel systems. Process design must account for defined temperature and pressure limitations, material compatibility, and mechanical loading. Supplier qualification, change control, and lifecycle management are integral to maintaining consistent process performance.
Facility Features
Facilities designed around single‑use technology emphasize material flow, segregation, and logistics rather than fixed utilities and systems. Layouts must accommodate expanded warehouse capacity for consumable, including storage, staging and kitting areas, and defined routes for clean materials to enter and bio‑contaminated waste to leave the clean areas or the facility. HVAC and cleanroom classifications must fully comply with Annex 1 and FDA cGMP expectations, despite reduced reliance on CIP/SIP systems. Waste handling strategies address high volumes of solid plastic waste, often requiring autoclaving or off‑site incineration, with careful consideration of operator safety and contamination control. Effective facilities integrate unidirectional flows, ergonomic handling solutions, and robust storage controls to protect material integrity and ensure uninterrupted manufacturing operations.
Fluor Projects
Bayer AG B68-Bio-1 Cell Culture Technology Center (CCTC) and B69-Cell Therapy Launch Facility
Location: Berkeley, California, USA
Scope: Construction Management, Commissioning, Qualification, Validation
Fluor provided EPCMV services for Bayer’s Berkeley campus’ 40,000-square-foot B68 Cell Culture Technology Center and 144,000-square-foot B69 Cell Therapy Launch Facility. These facilities feature flexible, single-use systems for multi-product biologic and cell therapy manufacturing, supporting late-phase and commercial production. B68 facility housed 2 x 2,000L bioreactors for mAb production with expansion up to 4 x 2,000L. The LEED v5 Platinum-certified B69 facility also earned ISPE FOYA recognition for social impact and sustainability.
cGMP Campus
Location: Washington, USA
Scope: Engineering and Long-Lead Equipment Procurement
Fluor supported initial feasibility/programming design, site selection support, master planning, conceptual and basic design for an entire 275,000-square-foot greenfield cGMP campus. The site comprised of utilizing single-use technology for drug substance and drug product manufacturing, utilities building, warehouse, and waste facilities. The facility includes dual 2,000L upstream suites with dedicated purification, as well as fill/finish with isolator technology for liquid and freeze-dried products.
Business Inquiries
Contact Fluor's sales team to learn how Fluor can help you with your business needs and what solutions Fluor offers in your industry. See the buttons below for questions on other topics.