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E541-00020

NovaSeptum® GO Transfer Unit

sterile; β-irradiated, Tube Application; Luer; 1000 mm; C-Flex®

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About This Item

UNSPSC Code:
41104105
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Quality Segment

400

material

polyester body, silicone septum (platinum-cured), 316 stainless steel cannula, C-Flex tubing

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

-73-132 °C temp. range (-99-270 °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

Packaging

1000mm C-Flex® 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.

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

Luer-Lok is a registered trademark of Becton-Dickinson & Co.
ASTM is a registered trademark of American Society for Testing and Materials
C-Flex is a registered trademark of Saint-Gobain Performance Plastics Corp.
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany

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Certificates of Analysis (COA)

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