material
TPE tubing, polyester body, silicone septum (platinum-cured), 316 stainless steel cannula
Quality Segment
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: no
parameter
-20-50 °C temp. range (-4-122 °F), 0.50 bar max. pressure (7.25 psi)
impurities
<2.15 EU/device bacterial endotoxins (LAL test)
fitting
female Luer-Lok® outlet (3-piece), male Luer-Lok® outlet (3-piece), outlet (injection site)
application(s)
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pharma/biopharma processes
sterile sampling
viral therapy
storage temp.
room temp
General description
Device configuration: single unit, Transfer tube set
The NovaSeptum® GO Transfer Unit is intended for transfer applications. It is available with a 2 mm needle and must be used with a NovaSeptum® GO holder. Transfer units are available with a range of different tubing materials (Thermoplastic, Silicone, and C-Flex®).
Application
Non-critical
Sampling
Sampling
Packaging
500mm TPE tube, 50 units per box
Preparation Note
Units are integrity tested at regular intervals during manufacturing.
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
Other Notes
- Septum: Platinum-cured silicone
- Body: Polyester
- Cannula: ASTM® 316 L Stainless steel
- Tubing: Thermoplastic elastomer (TPE), silicone or C-Flex® tube
- Outlet Tubing: 3-piece Luer-Lok®, containing a male, female and an injection site
Legal Information
ASTM is a registered trademark of American Society for Testing and Materials
C-Flex is a registered trademark of Saint-Gobain Performance Plastics Corp.
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
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