E9SU711

NovaSeptum^® GO Preloaded System with High Purity Bag, 9-port

sterile; β-irradiated

• Sinónimos: NovaSeptum^® GO High Purity Bag, Sterile_Sampling_Container
• Código UNSPSC: 41104105

Propiedades

• Materiales: 316 stainless steel cannula; PureFlex^™ polyethylene bag (fluid contact layer); TPE tubing; polyester body; silicone septum (platinum-cured)
• Nivel de calidad: 400
• Agency: according to ISO 11137 (sterilization); meets ISO 146441; 146441; meets ISO 88 biological reactivity (all component materials)
• esterilidad: sterile; β-irradiated
• Línea del producto: NovaSeptum^® GO
• Características: autoclavable: no
• Parámetros: -20-50 °C temp. range (-4-122 °F) (for 1000 mL); -80-50 °C temp. range (-112-122 °F) (for 50 mL to 250 mL); 0.30 bar max. pressure (4.35 psi) at ±25 °C (for 1000 mL); 0.50 bar max. pressure (7.25 psi) at ±25 °C (for up to 250 mL)
• impurezas: <2.15 EU/device bacterial endotoxins (LAL test)
• Adaptador: female Luer-Lok^® outlet (3-piece); male Luer-Lok^® outlet (3-piece); male Luer-Lok^® outlet (3-piece, containing a male, female and an injection site)
• aplicaciones: cell therapy; gene therapy; life science and biopharma; mAb; ophthalmics; parenterals; pathogen testing; pathogen testing; pharma/biopharma processes; pyrogen testing; sterile sampling; sterility testing; viral therapy
• temp. de almacenamiento: room temp

Descripción

Descripción general

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.

Aplicación

Regular Sampling Sample (with or without protective case).
Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications

Envase

E9SU711-10050 (9x50 ml bags, 3 units per box)
E9SU711-10100 (9x100 ml bags, 3 units per box)
E9SU711-10250 (9x250 ml bags, 3 units per box)
E9SU711-11000 (9x1000 ml bags, 3 units per box)

Componentes

• Septum: Platinum-cured silicone
• Body: Polyester
• Cannula: ASTM^® 316 L Stainless steel
• Fluid contact layer (bag): Polyethylene film (PureFlex^™ film)
• Tubing: Thermoplastic elastomer (TPE)
• Outlet Tubing: 3-piece Luer-Lok^®, containing a male, female and an injection site

Nota de preparación

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.

Información legal

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

PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany