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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.
is greatly
Biopharmaceutical Formulation 3350
The platinum-cured silicone tubing with
an ultra-smooth inner surface for sanitary
transfer of sensitive fluids.
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
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Complete Inventory of Standard Sizes
Available, Including Metric Sizes
Typical Applications
-
Pharmaceutical and Cosmetic Processing
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Medical Devices
-
Cell Harvest and Media Process Systems
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Sterile Fill Lines
-
Water for Injection (WFI) Transfer
-
Chemistry and Blood Analyzers
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Liquid Chromatography
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“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
The
biocompatibility of Tygon® 3350 has been tested and
found to be nontoxic in the following test
protocols:
-
USP
Systematic Toxicity and Intracutaneous
Reactivity
-
USP
Intramuscular Implant
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Cytotoxicity
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Blood
Compatibility
-
USP Physico
Chemical Tests
-
USP Pyrogen
Test
Click
for complete size chart. |
|
Property |
ASTM 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) |
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