• Ultra-low extractables to reduce leaching and contamination risk
• Extended pump life—outperforms competitors in durability
• Sterilization methods: Gamma (up to 50 kGy), EtO, Autoclave
• Temperature range: -62°C to 260°C (-80°F to 500°F)
• Excellent chemical resistance to acids, bases, salts, alcohols, emulsions, and high-purity water
• Mechanical properties:
• Shore A Hardness: 50 (ASTM D2240)
• Tensile Strength: 1293 psi (ASTM D412)
• Elongation: 719% (ASTM D412)
• Modulus @ 200%: 200 psi / 1.38 MPa (ASTM D412)
• Specific Gravity: 1.14 (ASTM D412)
• Available in multiple sizes with varied I.D., O.D., wall thickness, pressure, and vacuum ratings

• Genotoxicity Test: Passed ISO 10993-3 standards.
• Hemolysis: For both direct and indirect contact, meets criteria based on ASTM F756-00
• Irritation and Skin Sensitization: Meets ISO 10993-10 criteria.
• System Toxicity Testing: Systemic Injection and Rabbit Pyrogen: Meets ISO 10993-11 criteria.
• Biocompatibility: Passed USP <87> (in vitro) biological reactivity tests. Passed USP <88> Class VI (in vivo) biological reactivity tests.
• Endotoxin Testing: Passed USP <85> Limulus Amebocyte Lysate test.
• Particulate Testing: Compliant with USP <788> subvisible particulate standards.
• Sterility Test: Bacteriostasis & Fungistasis: Passed USP <71>
• Elastomeric Closures for Injection: Passed USP <381>
• Physicochemical Tests for Plastics: Passed USP <661>
• Test for Rubber Closure for Aqueous Infusions: Meets JP 59 criteria
• Silicone Elastomer for Closures and Tubing: Meets EP 3.1.9 criteria
• Total Extractables in Rubber Articles Intended for Repeated Use: Meets 21CFR Part 177.2600 criteria
• Regulatory Compliance: All formulas are Animal-Derived Component Free. Validation Guide and Regulatory Information Overview (RIO) available upon request.