E541-00020

NovaSeptum^® GO Transfer Unit

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

• UNSPSC Code: 41104105

Propiedades

• 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

Descripción

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 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