E9SU221

NovaSeptum^® GO Preloaded System with Autoclavable Bag, Vented, 9-port,

sterile; β-irradiated

• Synonym(e): NovaSeptum^® GO Autoclavable Bag, Vented, Sterile_Sampling_Container
• UNSPSC Code: 41104105

Eigenschaften

• Produktname: NovaSeptum^® GO Preloaded System with Autoclavable Bag, Vented, 9-port,, sterile; β-irradiated
• material: 316 stainless steel cannula; polyester body; polyethylene bottle (fluid contact layer); silicone septum (platinum-cured ); silicone tubing
• agency: according to ISO 11137 (sterilization); certified by the ISO 146441; meets USP 88 biological reactivity (all component materials)
• sterility: sterile; β-irradiated
• product line: NovaSeptum^® GO
• feature: autoclavable
• parameter: -20-125 °C temp. range (-4-257 °F); 0.30 bar max. pressure (4.35 psi) at ±25 °C
• impurities: <2.15 EU/device bacterial endotoxins (LAL test)
• fitting: male Luer-Lok^® outlet (with female sterile vent filter)
• application(s): bioburden testing; cell therapy; gene therapy; life science and biopharma; mAb; ophthalmics; parenterals; pathogen testing; pharma/biopharma processes; sterile sampling; viral therapy
• storage temp.: room temp
• Quality Level: 400

Beschreibung

Application

Mobile Tanks
Autoclaved

General description

Device configuration: Single Unit Sampling - Pre-loaded system

The NovaSeptum^® GO pre-loaded disposable magazine is available with various standard configurations using NovaSeptum^® GO high purity bags, autoclavable bags, bottles, transfer tubes or accurate volume (AV) syringe units. Other configurations are available upon request. For an optimal aseptic solution, use the NovaSeptum^® GO pre-loaded disposable magazine together with a 1.5" or 2" NovAseptic^® connector and NovaSeptum^® GO pre-loaded starter kit (5/9 shot stainless steel base). Ideal for sampling from aseptic and sterile processes, the NovaSeptum^® GO sterile sampling system provides consistently representative samples, safely and securely.

Other Notes

• Septum: Platinum-cured silicone
• Body: Polyester
• Cannula: ASTM^® 316 L Stainless steel
• Fluid contact layer (bag): Polypropylene film
• Tubing: Silicone
• Outlet Tubing: Male Luer-Lok^® with female sterile vent filter

Packaging

E9SU221-00215 (9x50 ml bags, 3 units per box)
E9SU221-00216 (9x100 ml bags, 3 units per box)
E9SU221-C0243 (9x250 ml bags, 3 units per box)
E9SU221-C0244 (9x1000 ml bags, 3 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.

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

NOVASEPTIC is a registered trademark of Merck KGaA, Darmstadt, Germany

NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany