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: 67D Shore A
- Moldable for Single-Use Assemblies
- USP 665 Extractable Testing
- Extensive Validation Testing
- Sealable + Weldable
Physical Properties
| Test Standard | ASTM Method | Typical Value | |
|---|---|---|---|
| Tensile Stress, 100% Strain, 73⁰F (psi) | D412 | 380 | |
| Tensile Stress, 300% Strain, 73⁰F (psi) | D412 | 680 | |
| Tensile Strength, Break, 73⁰F (psi) | D412 | 1180 | |
| Tensile Elongation Break, 73⁰F (%) | D412 | 600 | |
| Compression Set | D395B | 72⁰F, 22hr 19% | |
| 212⁰F, 22hr 69% | |||
| Specific Gravity | D792 | 0.89 | |
| Durometer | D2240 | 67 | |
Biocompatibility / Regulatory / Extractables
| Test Standard | Test Item | Test Result |
|---|---|---|
| ISO 10993-4 | Hemolysis | Pass |
| ISO 10993-5 | Cytotoxicity | Pass |
| ISO 10993-10 | Acute Systemic Toxicity Tests | Pass |
| USP 85 | Bacterial Endotoxin Tests | Pass |
| USP 87 | Biological Reactivity Tests, in vitro | Pass |
| USP 88 | Biological Reactivity Tests, in vitro, class VI | Pass |
| USP 665 | Extractables | Available Upon Request |
| USP 788 | Particulate Testing | Pass |
Sterilization Method
| Test Standard | Test Result |
|---|---|
| High-Pressure Steam Sterilization | 121°C/30min |
| Gamma Irradiation Sterilization | Up to 50kGy |
Product Details
| Product Number | I.D. | O.D. | Wall Thickness | BURST PRESSURE at 70°F (21.1°C) | Cut lengths | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| (in.) | (mm) | (in.) | (mm) | (in.) | (mm) | (psi) | (bar) | (ft) | (m) | |
| OneFlex-0125-0250 | 0.125 | 3.2 | 0.250 | 6.4 | 0.063 | 1.6 | CF* | CF* | 50 | 15.2 |
| OneFlex-0188-0313 | 0.188 | 4.8 | 0.313 | 8.0 | 0.063 | 1.6 | CF* | CF* | 50 | 15.2 |
| OneFlex-0188-0375 | 0.188 | 4.8 | 0.375 | 9.5 | 0.094 | 2.4 | CF* | CF* | 50 | 15.2 |
| OneFlex-0250-0375 | 0.250 | 6.4 | 0.375 | 9.5 | 0.063 | 1.6 | CF* | CF* | 50 | 15.2 |
| OneFlex-0250-0438 | 0.250 | 6.4 | 0.438 | 11.1 | 0.094 | 2.4 | CF* | CF* | 50 | 15.2 |
| OneFlex-0250-0500 | 0.250 | 6.4 | 0.500 | 12.7 | 0.125 | 3.2 | CF* | CF* | 50 | 15.2 |
| OneFlex-0375-0500 | 0.375 | 9.5 | 0.500 | 12.7 | 0.063 | 1.6 | CF* | CF* | 50 | 15.2 |
| OneFlex-0375-0563 | 0.375 | 9.5 | 0.563 | 14.3 | 0.094 | 2.4 | CF* | CF* | 50 | 15.2 |
| OneFlex-0375-0625 | 0.375 | 9.5 | 0.625 | 15.9 | 0.125 | 3.2 | CF* | CF* | 50 | 15.2 |
| OneFlex-0500-0688 | 0.500 | 12.7 | 0.688 | 17.5 | 0.094 | 2.4 | CF* | CF* | 50 | 15.2 |
| OneFlex-0500-0750 | 0.500 | 12.7 | 0.750 | 19.1 | 0.125 | 3.2 | CF* | CF* | 50 | 15.2 |
| OneFlex-0625-0875 | 0.625 | 15.9 | 0.875 | 22.2 | 0.125 | 3.2 | CF* | CF* | 50 | 15.2 |
| OneFlex-0750-1000 | 0.750 | 19.1 | 1.000 | 25.4 | 0.125 | 3.2 | CF* | CF* | 50 | 15.2 |
*For information, please contact the factory directly.