TYGON® 3350 Sanitary Silicone Tubing0 pages

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
TYGON® 3350 Sanitary Silicone Tubing
biopharmaceutical products
“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.
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. As a result, potential for particle entrapment is greatly reduced.
Competitor A TYGON® 3350 Competitor B