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Merck
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Key Documents

E511-10014

Millipore

NovaSeptum® GO传输单元

sterile; β-irradiated, Tube Application; Luer; 500 mm; TPE

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About This Item

分類程式碼代碼:
41104105

材料

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

品質等級

agency

according to ISO 11137 (sterilization)
according to ISO 146441
meets USP 88 Biological Reactivity (all component materials)

無菌

sterile; β-irradiated

產品線

NovaSeptum® GO

特點

autoclavable: no

參數

-20-50 °C temp. range (-4-122 °F)
0.50 bar max. pressure (7.25 psi)

雜質

<2.15 EU/device bacterial endotoxins (LAL test)

接頭

female Luer-Lok® outlet (3-piece)
male Luer-Lok® outlet (3-piece)
outlet (injection site)

應用

cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pharma/biopharma processes
sterile sampling
viral therapy

儲存溫度

room temp

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一般說明

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®).

應用

Non-critical
Sampling

包裝

500mm TPE tube, 50 units per box

成分

  • 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

準備報告

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.

法律資訊

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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