Single-Use Assemblies

Custom Fluid Management Solutions for Biopharma Manufacturing

Freudenberg Medical designs and builds single-use assemblies for critical bioprocessing applications. With expertise in silicone and thermoplastic extrusion, precision overmolding and cleanroom assembly, we deliver customized, high-purity solutions that ensure safe, consistent fluid transport in biopharmaceutical environments.

Custom Single-Use Assembly Capabilities


Our modular design approach allows us to create purpose-built assemblies based on customer specifications. These include:

  • Assembled tubing for secure, sterile fluid paths
  • Filling trees for aseptic transfer in fill-finish applications
  • Bottle cap assemblies with multiple inlets and outlets
  • Cut-to-length tubing combined with ancillary parts
  • Full pre-assembled systems or kits with individual components
  • Tubing with overmolded sanitary connectors and fittings
  • Y-connector manifolds and assemblies for multi-line flow control
  • Custom PEEK pharma filling needles – custom extrusion & assembly

All assemblies are cleanroom manufactured using validated processes to maintain product integrity and compliance with cGMP requirements.

Y-Connector Overmolding 
for Enhanced Flow Control

Freudenberg Medical’s custom-molded Y-connectors eliminate the flow restrictions and leakage risks associated with traditional barbed or clamped fittings. Our proprietary overmolding processes provide smooth internal fluid paths and strong mechanical seals, improving reliability and reducing contamination risks in critical bioprocessing steps.

Advantages of Overmolding

These Y-manifolds are ideal for upstream and downstream processes, offering a robust alternative to standard coupling solutions. Overmolds are applied directly to customer-specified tube ends using validated, high-capability tooling and processing controls.

helix tc sanitary ends

Overmolded TC Sanitary Ends for Single-Use Systems

 

Freudenberg Medical manufactures HelixTC™ overmolded sanitary ends for fluid transfer applications. An alternative to traditional barbed TC connections, HelixTC™ integrates PharmaFocus® Premium silicone tubing to produce a final assembly for aseptic manufacturing.
 

Discover more about HelixTC™
 

Clean & Sterile SUAs


Introducing CleanAssure™, an ISO Class 5 controlled cleanroom which provides biopharma customers with ready-to-use, clean and sterile single-use assemblies
 

  • Assemblies are washed, dried and gamma sterilized
  • Cleaning process uses ultrapure water and air within tightly controlled ISO 5 conditions
  • Reduces contamination risk, streamlines validation activities, and supports reliable supply
     

Learn More
 

silicone tubing

Integration with PharmaFocus® Premium Tubing and Components


Freudenberg Medical's single-use assemblies are fully compatible with our PharmaFocus® Premium product line, which includes high-purity, platinum-cured silicone tubing and molded sanitary ends.

Designed for single-use systems, these components are used globally in:


  • Cell and gene therapy
  • mRNA production
  • Biosimilar and monoclonal antibody (mAb) processing
  • Regenerative protein manufacturing
  • Small-batch and scale-up bioproduction
  • Laboratory and pilot-scale bioprocesses

Quality, Consistency, and Flexibility

Freudenberg Medical applies its rigorous quality standards and lean manufacturing principles to every biopharma assembly. Our GROWTTH® continuous improvement program ensures repeatable quality and drives efficiency across design, development, and production.

freudenberg medical location map

We Are Where You Need Us


Our manufacturing footprint includes global cleanroom facilities equipped for extrusion, molding, bonding, and assembly. This allows us to respond quickly to customer needs, reduce lead times, and ensure supply chain flexibility.
 

Visit our Global Locations

 

Freudenberg Medical Facility

PARTNER WITH FREUDENBERG MEDICAL

 

For over three decades, we have been driving innovation and partnering with medical device and pharmaceutical companies to deliver high-quality solutions—from ideation and market launch to volume production.

 

Our team of more than 250 engineers provides integrated development and manufacturing services that complement and accelerate an OEM’s ability to bring innovative products to market. Our customers benefit from our deep materials and technology expertise as well as a broad range of vertically integrated capabilities.

 

Together, let's get patients the treatment they need.

 

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