195 Industrial Drive, Northampton, MA 01060 413.320.4650

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 StandardASTM MethodTest Result
MinimumMaximum
Durometer Hardness (Shore A)D22406070
Tensile Strength (psi)D4121200-
Tensile Modulus (psi)D412350550
Tear Resistance (ppi)D62470-
Compression Set (%)D395-30
Specific GravityD7921.151.19

Biocompatibility / Regulatory / Extractables

Test StandardTest ItemTest Result
ISO 10993-4HemolysisIn Progress
ISO 10993-5CytotoxicityIn Progress
ISO 10993-10Acute Systemic Toxicity TestsIn Progress
USP<85>Bacterial Endotoxin TestsIn Progress
USP<87>Biological Reactivity Tests, in vitroIn Progress
USP<88>Biological Reactivity Tests, in vitro, class VIIn Progress
USP<665>ExtractablesIn Progress
USP<788>Insoluble Particles TestIn Progress
In Progress

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)
OneSil-65-0063-01250.0631.60.1253.20.03100.81258.62
OneSil-65-0063-01880.0631.60.1885.00.03150.8617.58
OneSil-65-0063-01880.1253.20.1885.00.0320.8614.21
OneSil-65-0125-02500.1253.20.2506.40.06251.61107.58
OneSil-65-0125-03130.1253.20.3138.00.09402.41349.24
OneSil-65-0125-03750.1253.20.3759.50.12503.216111.1
OneSil-65-0188-03130.1884.80.3138.00.06251.680.55.55
OneSil-65-0188-03750.1884.80.3758.00.09352.41016.96
OneSil-65-0188-04380.1884.80.43811.10.12503.21057.24
OneSIl-65-0250-03750.2506.40.3758.00.06251.6624.27
OneSil-65-0250-04380.2506.40.43811.10.09402.4886.07
OneSil-65-0250-05000.2506.40.50012.70.12503.2926.34
OneSil-65-0313-05000.3138.00.50012.70.09352.4765.24
OneSil-65-0313-05630.3138.00.56314.30.12503.293.56.45
OneSil-65-0375-05000.3759.50.50012.70.06251.6453.10
OneSil-65-0375-05630.3759.50.56314.30.09402.4584.00
OneSil-65-0375-06250.3759.50.62515.90.12503.2745.10
OneSil-65-0500-07500.50012.70.75019.10.12503.2604.14
OneSil-65-0625-08750.62515.90.87522.20.12503.2493.38
OneSil-65-0750-10000.75019.11.00025.40.12503.2463.17
OneSil-65-0750-11250.75019.11.12528.60.18754.8533.65
OneSil-65-1000-13751.00025.41.37534.90.18754.8493.38

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.