Biopharmaceutical Grade Silicone Tubing
Purity One™ OneSil biopharmaceutical grade silicone tubing has been formulated for demanding and critical fluid transfer applications in biopharmaceutical processing.
Features
- Platinum Cured Silicone
- Hardness: 65D Shore A
- Moldable for single-use assemblies
- High Pressure Ratings
- Temperature Range
- No impaired taste or odor
- USP 665 Extractable Testing
- Extensive Validation Testing
Physical Properties
| Test Standard | ASTM Method | Test Result | |
|---|---|---|---|
| Minimum | Maximum | ||
| Durometer Hardness (Shore A) | D2240 | 60 | 70 |
| Tensile Strength (psi) | D412 | 1200 | - |
| Tensile Modulus (psi) | D412 | 350 | 550 |
| Tear Resistance (ppi) | D624 | 70 | - |
| Compression Set (%) | D395 | - | 30 |
| Specific Gravity | D792 | 1.15 | 1.19 |
Biocompatibility / Regulatory / Extractables
| Test Standard | Test Item | Test Result |
|---|---|---|
| ISO 10993-4 | Hemolysis | Pass |
| ISO 10993-5 | Cytotoxicity | Pass |
| ISO 10993-11 | 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 | In Progress |
| 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) | ||||
|---|---|---|---|---|---|---|---|---|
| (in.) | (mm) | (in.) | (mm) | (in.) | (mm) | (psi) | (bar) | |
| OneSil-65-0063-0125 | 0.063 | 1.6 | 0.125 | 3.2 | 0.032 | 0.8 | 125 | 8.62 |
| OneSil-65-0063-0188 | 0.063 | 1.6 | 0.188 | 5.0 | 0.032 | 0.8 | 61 | 7.58 |
| OneSil-65-0063-0188 | 0.125 | 3.2 | 0.188 | 5.0 | 0.032 | 0.8 | 61 | 4.21 |
| OneSil-65-0125-0250 | 0.125 | 3.2 | 0.250 | 6.4 | 0.063 | 1.6 | 110 | 7.58 |
| OneSil-65-0125-0313 | 0.125 | 3.2 | 0.313 | 8.0 | 0.094 | 2.4 | 134 | 9.24 |
| OneSil-65-0125-0375 | 0.125 | 3.2 | 0.375 | 9.5 | 0.125 | 3.2 | 161 | 11.1 |
| OneSil-65-0188-0313 | 0.188 | 4.8 | 0.313 | 8.0 | 0.063 | 1.6 | 80.5 | 5.55 |
| OneSil-65-0188-0375 | 0.188 | 4.8 | 0.375 | 8.0 | 0.094 | 2.4 | 101 | 6.96 |
| OneSil-65-0188-0438 | 0.188 | 4.8 | 0.438 | 11.1 | 0.125 | 3.2 | 105 | 7.24 |
| OneSIl-65-0250-0375 | 0.250 | 6.4 | 0.375 | 8.0 | 0.063 | 1.6 | 62 | 4.27 |
| OneSil-65-0250-0438 | 0.250 | 6.4 | 0.438 | 11.1 | 0.094 | 2.4 | 88 | 6.07 |
| OneSil-65-0250-0500 | 0.250 | 6.4 | 0.500 | 12.7 | 0.125 | 3.2 | 92 | 6.34 |
| OneSil-65-0313-0500 | 0.313 | 8.0 | 0.500 | 12.7 | 0.094 | 2.4 | 76 | 5.24 |
| OneSil-65-0313-0563 | 0.313 | 8.0 | 0.563 | 14.3 | 0.125 | 3.2 | 93.5 | 6.45 |
| OneSil-65-0375-0500 | 0.375 | 9.5 | 0.500 | 12.7 | 0.063 | 1.6 | 45 | 3.10 |
| OneSil-65-0375-0563 | 0.375 | 9.5 | 0.563 | 14.3 | 0.094 | 2.4 | 58 | 4.00 |
| OneSil-65-0375-0625 | 0.375 | 9.5 | 0.625 | 15.9 | 0.125 | 3.2 | 74 | 5.10 |
| OneSil-65-0500-0750 | 0.500 | 12.7 | 0.750 | 19.1 | 0.125 | 3.2 | 60 | 4.14 |
| OneSil-65-0625-0875 | 0.625 | 15.9 | 0.875 | 22.2 | 0.125 | 3.2 | 49 | 3.38 |
| OneSil-65-0750-1000 | 0.750 | 19.1 | 1.000 | 25.4 | 0.125 | 3.2 | 46 | 3.17 |
| OneSil-65-0750-1125 | 0.750 | 19.1 | 1.125 | 28.6 | 0.188 | 4.8 | 53 | 3.65 |
| OneSil-65-1000-1375 | 1.000 | 25.4 | 1.375 | 34.9 | 0.188 | 4.8 | 49 | 3.38 |