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Safety Information

E541-00020

Millipore

NovaSeptum® GO Transfer Unit

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

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material

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

Quality Level

400

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

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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

Components

  • 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

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.

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
C-Flex is a registered trademark of Concept Polymer Technologies Inc.
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany

Regulatory Information

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