Premium Grade Silicone Tubing
Platinum-Cured Single Lumen USP Class VI FDA Masterfile
Features & 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 |
0.0% None Detected None Complies Complies Complies Complies Complies Complies Complies Complies Complies None Detected |
|
HPLC analysis of IPa Extract |