195 Industrial Drive, Northampton, MA 01060 413.320.4650

Biopharmaceutical Grade TPE Tubing

Purity One™  OneFlex biopharmaceutical grade thermoplastic elastomer (TPE) tubing has been formulated for demanding and critical fluid transfer applications in biopharmaceutical processing. OneFlex is an excellent choice for applications that require heat sealing and sterile welding capabilities.

Features

  • Thermoplastic Elastomer (TPE)
  • Hardness: 65D Shore A
  • Moldable for single-use assemblies
  • Temperature Range
  • USP 665 Extractable Testing
  • Extensive Validation Testing

Physical Properties

Test StandardASTM MethodTypical Value
Tensile Stress, 100% Strain, 73⁰F (psi)D412380
Tensile Stress, 300% Strain, 73⁰F (psi)D412680
Tensile Strength, Break, 73⁰F (psi)D4121180
Tensile Elongation Break, 73⁰F (%)D412600
Compression SetD395B72⁰F, 22hr 19%
212⁰F, 22hr 69%
Specific GravityD7920.89
DurometerD224067

Biocompatibility / Regulatory / Extractables

Test StandardTest ItemTest Result
ISO 10993-4HemolysisPass
ISO 10993-5CytotoxicityPass
ISO 10993-10Acute Systemic Toxicity TestsPass
USP<85>Bacterial Endotoxin TestsPass
USP<87>Biological Reactivity Tests, in vitroPass
USP<88>Biological Reactivity Tests, in vitro, class VIPass
USP<665>ExtractablesSee Extractables Report
USP<788>Insoluble Particles TestPass≥ 10 μm: ≤10 pcs/mL
≥ 25 μm: ≤1pcs/mL

Sterilization Method

Test StandardTest Result
High-Pressure Steam Sterilization121°C/30min
Gamma Irradiation SterilizationUp to 50kGy

Product Details

Product NumberI.D.O.D.Wall
Thickness
BURST PRESSURE
at 70°F (21.1°C)
(in.)(mm)(in.)(mm)(in.)(mm)(psi)(bar)
OneFlex-65-0125-02500.1253.20.2506.40.06251.6CF*CF*
OneFlex-65-0188-03130.1884.80.3138.00.06251.6CF*CF*
OneFlex-65-0188-03750.1884.80.3759.50.09352.4CF*CF*
OneFlex-65-0250-03750.2506.40.3759.50.06251.6CF*CF*
OneFlex-65-0250-04380.2506.40.43811.10.0942.4CF*CF*
OneFlex-65-0250-05000.2506.40.50012.70.1253.2CF*CF*
OneFlex-65-0375-05000.3759.50.50012.70.06251.6CF*CF*
OneFlex-65-0375-05630.3759.50.56314.30.0942.4CF*CF*
OneFlex-65-0375-06250.3759.50.62515.90.1253.2CF*CF*
OneFlex-65-0500-06880.50012.70.68817.50.0942.4CF*CF*
OneFlex-65-0500-07500.50012.70.75019.10.1253.2CF*CF*
OneFlex-65-0625-08750.62515.90.87522.20.1253.2CF*CF*
OneFlex-65-0750-10000.75019.11.00025.40.1253.2CF*CF*

*For information, please contact the factory directly.

Not finding what you are looking for?

Additional information and resources are available upon request. This includes the OneSil validation guides, extractables reports and more.