2D/ 3D Single Use Storage Bags

US8130 SUIS: Tubing Assemblies

US8130 SUIS: Tubing Assemblies

Single-use tubing and integrated assemblies are pre-sterilized, ready-to-use systems designed for fluid transfer in bioprocessing applications. Manufactured and packaged in ISO Class 5–7 cleanrooms, these assemblies ensure sterility and reduce contamination risk. Each assembly is custom-built using pharmaceutical-grade tubing, connectors, filters, and clamps, then sterilized—typically by gamma irradiation.

They are widely used in buffer/media preparation, TFF, chromatography, bioreactor harvest, sampling, and sterile filling. By eliminating the need for cleaning and validation, these systems accelerate changeovers and enhance process safety and efficiency.

Fully customizable in tubing size, layout, and components, they comply with global standards such as USP, ISO 10993, and FDA 21 CFR, making them ideal for use in regulated biopharmaceutical environments.

  • Key Features
  • Applications
  • Advantages
  • Customization Options
  • Assembled and packed in certified ISO 5–7 cleanroom environments
  • Sterilized via gamma irradiation and ready to deploy
  • Leak-proof and closed-system construction
  • Modular design with compatibility across multiple processing platforms
  • High chemical resistance and thermal stability
  • Easy integration with filtration units, bioreactors, and filling lines
  • Configurable with filters, clamps, sampling ports, and multiple connection types
  • Validated materials compliant with USP <88>, ISO 10993, and FDA regulations
  • Supplied with complete documentation, including CoC and lot traceability
  • Buffer/media preparation & transfer
  • Tangential Flow Filtration (TFF)
  • Chromatography feed and elution
  • Bioreactor sampling and harvest
  • Aseptic transfer and filling into bags or bottles
  • Integration with upstream/downstream systems
  • Minimizes risk of contamination
  • Reduces downtime between batches
  • Eliminates cleaning validation
  • Enhances batch-to-batch consistency
  • Speeds up setup and changeover
  • Supports scalable GMP-compliant operations
  • Tubing length, ID/OD sizing
  • Connector and clamp configurations
  • Filter integration
  • Sampling ports or pinch valves
  • Bag or bottle interface
  • Custom labels and gamma exposure levels
  • Double or triple packaging for cleanroom entry

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