Tygon® 3350 Sanitary Silicone Tubing
Biopharmaceutical Formulation 3350, the platinum-cured silicone tubing with an ultra-smooth inner surface for sanitary transfer of sensitive fluids.

In a comparison of images of the inner surfaces of TYGON® 3350 silicone tubing and two competitors (captured at 500 x magnification with an electron scanning microscope), TYGON clearly exhibits superior smoothness.

“Engineered” Ultra-Smooth Inner Surface

The inner surface of Tygon® 3350 silicone tubing has been designed to reduce the risk of particle entrapment and microscopic build-up during fluid transfer. In-house analysis of the inner surface of Tygon® 3350 silicone tubing compared to other silicone tubing shows that it is up to three times smoother. In addition, when compared to stainless steel tubing, Tygon® 3350 tubing exhibits a smoother surface by a factor of up to 40.

A smoother fluid path also helps to facilitate complete sanitation of a fluid transfer system. Even in repeat use applications, Tygon® 3350 silicone tubing may prevent residue build-up, aiding in complete cleaning and sterilization.

Additionally, the smooth inner surface of the Tygon® 3350 silicone tubing improves fluid flow characteristics by reducing surface area.

Lower Extractables and Superior Biocompatibility

Tygon® 3350 silicone tubing is compounded to meet the most demanding requirements of biocompatibility. In-house extractability tests have shown that Tygon® 3350 silicone tubing has a low extractable content. Lower extractables help to maintain the purity of transported fluids in sensitive applications.

Platinum-cured Tygon® 3350 silicone tubing complies fully with the requirements of the USP Class VI Criteria and is entirely non-toxic, non-hemolytic and non-pyrogenic. Additionally, Tygon® 3350 silicone tubing meets 3-A Sanitary Standards, FDA 21 CFR Part 177.2600 Criteria and NSF 51 Standard. Tygon® 3350 silicone tubing also complies with the ISO 10993 guidelines for contact with blood (or other body fluids and tissue) for up to 30 days as listed in the FDA GP-95.


Sterilization of Tygon® 3350
  • Autoclavable - Steam 30 minutes at 15 psi (250°F).
  • Gas - Ethylene Oxide.
  • Radiation - Radiation up to 2.5 MRad.
TYGON® 3350 Toxicological Profile
  • USP Systematic Toxicity and Intracutaneous Reactivity
  • USP Intramuscular Implant
  • Cytotoxicity
  • Blood Compatibility
  • USP Physico Chemical Tests
  • USP Pyrogen Test

 


Features/Benefits
  • Ultra-Smooth Inner Bore Reduces Potential for Particle Entrapment
  • Minimal Extractables Help Maintain Fluid Integrity
  • Documented Biocompatibility for Sensitive Applications
  • Excellent Fluid Flow Characteristics
  • Fully Tested to ISO 10993 Standards to Facilitate Validation Process
  • Complete Inventory of Standard Sizes Available, Including Metric Sizes
Typical Applications
  • Pharmaceutical and Cosmetic Processing
  • Medical Devices
  • Cell Harvest and Media Process Systems
  • Sterile Fill Lines
  • Water for Injection (WFI) Transfer
  • Chemistry and Blood Analyzers
  • Liquid Chromatography

 

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Tygon® 3350 Tubing Typical Physical Properties
PropertyASTM Method Value or Rating
Durometer Hardness - Shore A, 15 sec D2240-91 50
Color - Translucent
Tensile Strength - psi (MPa) D412-92 1,450 (10)
Ultimate Elongation, % D412-92 770
Tear Resistance - lb-f/inch (kN/m) D624-91 - Die B 200 (35)
Specific Gravity D792-91 1.14
Water Absorption, % - 24 hours @ 23ºC D570-81 0.11
Compression Set Constant Deflection, % - @ 158ºF (70ºC) for 22 hours
Compression Set Constant Deflection, % - @ 347ºF (175ºC) for 22 hours
D395-89 - Method B 7
35
Brittleness by Impact Temp - ºF (ºC) D746-79 -112 (-80)
Max Recommended Operating Temp - ºF (ºC) - 400 (204)
Dielectric Strength - v/mil (kV/mm) D149-93 480 (19.0)
Tensile Modulus, @ 200% Elongation, psi (MPa) D412-92 280 (1.9)

Unless otherwise noted, all tests were conducted at room temperature (73°F). Values shown were determined on 0.075" thick extruded strip or 0.075" thick molded ASTM plaques or molded ASTM durometer buttons.

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