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When off-the-shelf assemblies don't fit your process, MonoBiologics engineers custom single-use fluid paths built to your exact specifications. Our in-house team works directly with you from initial design through final assembly, ensuring every connection, every component, and every material choice is optimised for your application. Whether you're scaling up, troubleshooting an existing process, or building something entirely new, we deliver the speed and flexibility your process demands for pharma and biotech teams worldwide.
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Our Process
Requirements Consultation
We learn your process, fluid types, flow rates, pressures and constraints before anything is designed.
Component Selection
Pumps, valves, bags, sensors. Every component specified for your exact application and process requirements.
Flow Path Design
Our engineers design the complete assembly to your process specification, optimised for performance and reliability.
Delivery
Complete, ready-to-implement flow path delivered to your facility. Fully assembled, tested and ready to go.
Testing and Validation
Every assembly is rigorously tested and validated before it leaves our facility. No shortcuts, no exceptions.
In-House Assembly
Built and assembled entirely at MonoBiologics. One accountable partner from first component to final assembly.
Ready to discuss your flow path requirements?
Speak to Our Engineering TeamTangential Flow Filtration
Single-use flow paths are used in almost every TFF operation in downstream bioprocessing, including concentration, diafiltration and buffer exchange steps for monoclonal antibodies and biologics.
Buffer and Media Preparation
Single-use assemblies are extensively used for sterile fluid transfer during buffer preparation and media preparation, eliminating cleaning validation and reducing changeover time between batches.
Upstream Cell Culture
From media transfer into bioreactors to inoculation and harvest, single-use flow paths support closed upstream cell culture operations where sterility and contamination control are critical.
Depth Filtration and Clarification
Single-use fluid path assemblies are a standard approach for harvest clarification and depth filtration steps, connecting filters, bags and downstream equipment in a pre-sterilised, ready-to-use format.
Viral Inactivation
Single-use flow paths are widely used in viral inactivation steps, providing a closed, controlled fluid path for low-pH hold operations — the standard method for inactivating enveloped viruses in mAb and biopharmaceutical manufacturing after protein A capture.
Fill and Finish
Custom single-use assemblies support sterile filling and final formulation operations, managing fluid transfer into filling lines and final drug product containers in a fully closed, disposable format.
Why MonoBiologics
Complete In-House Control
Design, manufacture, assembly, testing and delivery all under one roof. No subcontractors, no third-party handoffs, no gaps in accountability. When something needs to change, we change it without waiting on anyone else.
We Also Overmold
Need custom overmolded components integrated into your flow path? We handle that entirely in-house too.
Learn About Our OvermoldingFaster Turnaround
Fewer handoffs means faster delivery. When design, manufacturing and assembly all happen under the same roof, there are no delays waiting on external suppliers or third-party fabricators. Your timeline stays on track.
Direct Access to Engineers
You speak directly to the engineers actually building your system, not a sales team relaying messages. If you have a technical question or need to adjust the spec, you get a straight answer from the person who knows your assembly inside out.
Scalable With You
We support you from early R&D through to full commercial manufacturing. As your volumes grow and your process evolves, we adapt your flow path with you. One partner for the entire journey, not just the first build.
Full Transparency
You know exactly where your assembly is at every stage of the process. No black boxes, no surprises, no chasing updates. We keep you informed from first consultation through to delivery so you can plan with confidence.
Complete In-House Control
Design, manufacture, assembly, testing and delivery all under one roof. No subcontractors, no third-party handoffs, no gaps in accountability. When something needs to change, we change it without waiting on anyone else.
We Also Overmold
Need custom overmolded components integrated into your flow path? We handle that entirely in-house too.
Learn About Our OvermoldingFaster Turnaround
Fewer handoffs means faster delivery. When design, manufacturing and assembly all happen under the same roof, there are no delays waiting on external suppliers or third-party fabricators. Your timeline stays on track.
Direct Access to Engineers
You speak directly to the engineers actually building your system, not a sales team relaying messages. If you have a technical question or need to adjust the spec, you get a straight answer from the person who knows your assembly inside out.
Scalable With You
We support you from early R&D through to full commercial manufacturing. As your volumes grow and your process evolves, we adapt your flow path with you. One partner for the entire journey, not just the first build.
Full Transparency
You know exactly where your assembly is at every stage of the process. No black boxes, no surprises, no chasing updates. We keep you informed from first consultation through to delivery so you can plan with confidence.
FAQ
A single-use flow path, also referred to as a single-use fluid path or single-use assembly, is a pre-assembled sterile fluid pathway used in bioprocessing and pharmaceutical manufacturing. Single-use flow paths typically combine single-use tubing, connectors, valves, bags and sensors into a complete ready-to-use assembly designed for a single production run. They are used across a wide range of bioprocessing applications including upstream cell culture, downstream purification, buffer preparation, TFF and viral inactivation. Single-use flow paths and single-use assemblies have become the standard approach in modern pharmaceutical and biopharmaceutical manufacturing due to their ability to eliminate cross-contamination risk, reduce cleaning validation requirements and accelerate process changeovers between production runs.
A single-use flow path assembly can include single-use tubing, single-use diaphragm valves, single-use pumps, single-use bags, single-use sensors, standard connectors and custom overmolded connectors. MonoBiologics designs and assembles all single-use flow path components in-house, selecting each component specifically for your process requirements rather than adapting from a standard catalogue.
Yes. MonoBiologics specialises in custom single-use flow path design and custom single-use assembly fabrication for pharmaceutical and biotech applications. Our engineering team designs bespoke single-use fluid path assemblies around your specific process requirements, flow rates and fluid types. We handle the complete process from initial consultation through to a tested, validated single-use assembly delivered to your facility.
Yes. Our single-use flow path assemblies and single-use fluid path assemblies are designed and manufactured to meet GMP requirements for pharmaceutical and biopharmaceutical manufacturing environments.
Lead times for custom single-use flow path assemblies and custom single-use assemblies vary depending on complexity. Contact our engineering team to discuss your single-use fluid path requirements and get a timeline specific to your project.
Every single-use flow path assembly is tested and validated before leaving our facility. We don't ship single-use fluid path assemblies or single-use assemblies that haven't passed our internal testing process.
Yes. Single-use flow paths and single-use assemblies are widely used across upstream bioprocessing including bioreactor fluid management, and downstream bioprocessing applications such as TFF, chromatography and viral inactivation.
All MonoBiologics single-use flow path assemblies and single-use assemblies are designed and manufactured in Ireland. We supply single-use bioprocessing assemblies to pharmaceutical and biotech companies globally.
A single-use flow path eliminates the cleaning, sterilisation and validation burden associated with traditional stainless steel fluid paths. With traditional stainless steel systems, every fluid contact surface must go through CIP and SIP cycles between batches, requiring significant time, resource and validated procedures. Single-use fluid path assemblies and single-use assemblies arrive pre-sterilised and ready to connect, removing the need for cleaning validation entirely. This reduces batch turnaround time, lowers contamination risk between production runs and gives multiproduct facilities the flexibility to change process configurations quickly without dedicating equipment to a single product. For pharmaceutical and biotech manufacturers scaling up or running multiple products, the shift to single-use flow paths and single-use assemblies represents a significant operational advantage over stainless steel.
Yes. MonoBiologics manufactures custom LSR overmolded components entirely in-house and integrates them directly into your single-use flow path, single-use assembly or single-use fluid path assembly. This means your complete single-use assembly, including any bespoke overmolded connectors, is designed, manufactured and delivered by one partner.
Get Started
Tell us about your process and our engineering team will design a complete single-use assembly around your requirements. From brief to delivered flow path, we handle everything.