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 | ||
