E461
NovaSeptum® GO Accurate Volume Syringe Sampling System
sterile; β-irradiated
Synonym(s):
NovaSeptum® GO Accurate Volume Syringes
About This Item
Recommended Products
material
316 stainless steel cannula
polycarbonate syringe (fluid contact layer)
polyester body
silicone septum (platinum-cured)
silicone syringe (medical fluid contact layer; platinum cured silicone)
silicone tubing
Quality Level
agency
according to ISO 11137 (sterilization)
according to ISO 146441
meets USP 88 Biological Reactivity (all component materials)
sterility
sterile; β-irradiated
product line
NovaSeptum® GO
feature
autoclavable
parameter
-80-121 °C temp. range (-112-250 °F) (20ml)
-80-134 °C temp. range (-112-273 °F) (5ml)
0.50 bar max. pressure (7.25 psi)
impurities
<2.15 EU/device bacterial endotoxins (LAL test)
fitting
female Luer-Lok® outlet
male Luer-Lok® outlet
application(s)
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pathogen testing
pathogen testing
pharma/biopharma processes
pyrogen testing
sterile sampling
sterility testing
viral therapy
storage temp.
room temp
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General description
Application
Packaging
E461-90020 (20 ml syringes, 40 units per box)
Components
- Septum: Platinum-cured silicone
- Body: Polyester
- Cannula: ASTM® 316 L Stainless steel
- Fluid contact layer (syringe): Polycarbonate, platinum-cured silicone, medical silicone fluid
- Tubing: Silicone
- Outlet Tubing: Female and male Luer-Lok®
Preparation Note
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
Legal Information
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