NSF-ISR

Premium Grade Silicone Tubing

 

Peroxide-Cured Single Lumen USP Class VI FDA Masterfile

 
 


Premium Grade Silicone TubingFeatures & Benefits:
• Extended post cure for lowest level extractables
• Biocompatible, inert, non-reactive with other elements
• Odourless, tasteless, non-toxic for use in medical, food, drug,
   personal care, and deionized water applications
• Non-leaching plasticizers, does not emit contaminants
• Sterilizable by radiation, ETO, steam – 30 psi at 253°F (123°C)
   for use in sterile applications, reusability
• Resists temperature extremes – flexibility retention:
  -65°F to 400°F (-54°C to 204°C); brittle point: -100°F (-73°C)
• Translucent for visual monitoring
• Colour stripe, tint for custom process control identification

Biocompatibility Tests:
• Tests conducted per the standards set by the United States
   Pharmacopeia National Formulary XVII (NF XVII), 1990, Class
   VI Biological Test for Plastics,
• SF1291 Meets or exceeds the requirements of these protocols. 

Elastomer Physical Properties  
  ASTM Method Typical Values
Hardness Durometer A D-2240 60  
Tensile strength psi D-412 1377  
Elongation % D-412 500  
Tear resistance Die B ppi D-624 114  
Specific Gravity D-746  1.15   
Compression set
%(22 hours at 350°F)
D-395 30  
  Testing Sample Results Per Standard
 

Hemolysis Test
Heavy Metals as Lead
Cell Culture Toxicity
Clarity of Solution
Substance Solution in Hexane
Volatile Matter
Mineral Oils
Phenylated Compounds

0.0%
None detected
None
Complies
Complies
Complies
Complies
Complies