NSF-ISR

Premium Grade Silicone Tubing

 

Platinum-Cured Single Lumen USP Class VI FDA Masterfile

 
 


Premium Grade Silicone TubingFeatures & Benefits:
• Platinum cured for a high degree of purity
• Extended post cure for lowest level extractables
• Biocompatible, inert, non-reactive with other elements per
systemic testing
• Odorless, tasteless, non-toxic for use in medical, food, drug,
personal care, and deionized water applications
• Non-leaching plasticizers
• 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); brittlepoint: -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
Pharmacopoeia National Formulary, Class VI Biological Test for
Plastics, and also conducted according to Ph Eur VI.1.3.2.
• SF Medical Platinum Cured Material meets or exceeds the
requirements of these protocols. Copies of the studies and raw
data are on file at Trelleborg Sealing Solutions Hudson (formerly
SF Medical).

Elastomer Physical Properties
  ASTM Method Typical Values
Hardness D-22406 60  
Durometer A      
Tensile strength psi D-412 1275  
Elongation % D-412675 625  
Tear resistance D-624 1.15  
Die B ppi      
Compression set
%(22 hours at 350°F)
D-395 40  
  Testing Sample Results Per Standard
 

Hemolysis Test
Heavy Metals as Lead
Cell Culture Toxicity
Chromotropic Acid Test
Clarity of Solution
Acidity/Alkalinity
Substances Soluble in Hexane
Volatile Matter
Mineral Oils
Phenylated Compounds
Residual Peroxides
Platinum
Dichlorobenzoic Acid Residue

0.0%
None Detected
None
Complies
Complies
Complies
Complies
Complies
Complies
Complies
Complies
Complies
None Detected
  HPLC analysis of IPa Extract