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Single-Use Bioprocess Bags & Bottles Single-Use Mixing System Aseptic Connect & Disconnect Aseptic Sampling & Filling Bioprocess Supporting Vessels Connectors and Fittings Tubing
BioHub® 2D Single-use Storage Bag BioHub® 3D Single-use Storage Bag BioHub® Single-use Freeze-thaw Bag NovaLinX® Nuclease-free Single-use Consumables HemoLinX® CFT Freezing Bag BioHub® Single-use Storage Bottle BioHub® Storage Bottle Tool Kit BioHub® BM Single-use Magnetic Mixing System BioHub® DS Single-use Desktop Mixing System BioHub® UM Top-driven Mixing System BioHub® FD Feeding System BioHub® Single-use Powder-feeding Bag BioHub® MB Single-use Mixing Bag BioHub® Single-use Weighing Bag BioHub® Sealer Ⅱ BioHub® Handheld Sealer BioHub® Welder Ⅱ BioHub® Sterile Cutter BioHub® Single-use Sampling Bag BioHub® Single-use Sampling Bottle BioHub® Sterile Water Sampling Bag BioHub® S Sterile Sampling Tray BioHub® Single-use Filling System BioHub® Fill Single-use Bulk Filling System Circular Plastic Bin Plastic Freeze-thaw Box Cubic Foldable Plastic Bin Cubic Stainless Steel Tank Storage Tray Storage Tray Transfer Cart BioHub® Connectors BioHub® Sanitary Clamp Fittings Biohub® Hose Plug BioHub® Diaphragm Gasket BioHub® Clamp & End Cap BioHub® Integrated Diaphragm Gauge Tee SynaLinX® TST Platinum Cured Silicone Tubing SynaLinX® MST Platinum Cured Silicone Tubing SynaLinX® HST Platinum Cured Silicone Tubing SynaLinX® PST Platinum Cured Silicone Pump Tubing SynaLinX® RST Reinforced Silicone Tubing SynaLinX® WST Steel Wire Reinforced Silicone Tubing SynaLinX® BPT Wear Resistant Tubing SynaLinX® B-Flex™ Thermoplastic Tubing SynaLinX® Molded Silicone Assemblies CytoLinX® RW 10-200L Single-use Rocking Bioreactor CytoLinX® GB 1-20L Benchtop Glass Bioreactor CytoLinX® BR 10-2000L Single-use Bioreactor CytoLinX® WB Single-use Cell Culture Bag CytoLinX® WB Single-use Cell Therapy Bag CytoLinX® Single-use Breathable Cell Bag CytoLinX® BRTF Single-use Top-driven Bioreactor Bag BioHub® Magnetic Separator BioHub® Automated Bioprocess Analyzer Puredex® Cyto-1 Microcarrier Chrom-LinX® Manual Compression Chromatography Column Chrom-LinX® Automated Chromatography Column Chrom-LinX® Auto TH Chromatography Column PuriLinX® Benchtop Chromatography System VERDOT Ips² InPlace™ Process-scale Chromatography Column ChromaX® Geldex® Prepacked Column Chrom-Trap® & Chrom-Screen™ Prepacked Column ChromaX® A20 Affinity Chromatography Column Chromstar® FF Resin for Size Exclusion Chromatography Chromstar® CL Resin for Size Exclusion Chromatography Chromstar® B Resin for Size Exclusion Chromatography Geldex® PG Resin for Size Exclusion Chromatography Puredex® G Resin for Size Exclusion Chromatography Puredex® LH-20 Resin for Size Exclusion Chromatography Maxtar® Resins for Ion Exchange Chromatography Maxtar® HR Resins for Ion Exchange Chromatography Chromstar® XL Resins for Ion Exchange Chromatography Chromstar® BB Resins for Ion Exchange Chromatography Chromstar® FF Resins for Ion Exchange Chromatography Chromstar® HP Resins for Ion Exchange Chromatography Chromstar® XL Resins for Ion Exchange Chromatography Puredex® Resins for Ion Exchange Chromatography MaXtar® ARPA Affinity 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SynaLinX® Molded Silicone Assemblies

SynaLinX® Molded Silicone Assemblies are custom-designed to meet specific process needs, made from high-purity, medical-grade elastomers and precision injection molded for seamless integration with tubing systems. The one-piece molded design eliminates common risks of barbed fittings—leakage, dead legs, and cross-contamination—ensuring maximum safety in biopharmaceutical processes.


These customized assemblies offer optimized flow path design and enhanced surface finish to ensure absolute fluid integrity during the transfer of critical media, biological substances, and final drug products. Each unit is fully validated through pressure testing, particle shedding evaluation, and extractables/leachables analysis.


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Features Applications Specifications Contact us

Features of SynaLinX® Molded Silicone Assemblies

  • Smooth surface finish

  • Eliminates residue and leakage risks

  • Ready-to-use, available in sizes from 1/16” to 1”, customizable lengths, multiple specifications available

  • Working temperature: − 50 ° C to 200 °

  • Prevents filling inaccuracies caused by pulsation

  • Can be sterilized by Autoclave and Gamma-irradiation


Applications of SynaLinX® Molded Silicone Assemblies

  • Aseptic filling

  • Ultrafiltration systems

  • Sampling



Specifications of SynaLinX® Molded Silicone Assemblies

Validation

Test Item

Reference StandardTest Result
Hardness, shore AASTM D224060 ± 5

Elongation at break, %

ASTM D412

≥ 250

Tensile Strength, MPa

ASTM D412≥ 6.5
Bacterial Endotoxins

Same as USP

<85>)

< 0.25EU/mL

Subvisible Particles

same as USP

<788>

Particle size ≥ 10 μm: ＜ 25 particles/mL

Particle size ≥ 25 μm: ＜ 3 particles/mL

Biocompatibility

USP <87>

USP <88>CLASS VI

ISO 10993-4

ISO 10993-5

ISO 10993-10

ISO 10993-11

ISO 10993-23

Pass

Plastic Packaging System

USP <661>Pass
Elastomeric Closures for injectionsUSP <381>Pass
Extractables Study

BPOG

Pass


**Please be advised that this product is only available for sale and after-sales support in certain regions. For further details, kindly consult with your local sales representative. Thank you for your understanding.

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