E874

NovaSeptum^® GO Bottle Sampling System, Manifold (5-valve)

sterile; γ-irradiated

• Sinónimos: NovaSeptum^® GO Bottle
• Código UNSPSC: 41104105

Propiedades

• Materiales: 316 stainless steel cannula; PureFlex^™ polyethylene bag (drainage bag); TPE tubing; polyester body; polyethylene bottle (fluid contact layer); silicone septum (platinum-cured )
• Nivel de calidad: 400
• Agency: according to ISO 11137 (sterilization); certified by the ISO 146441; meets USP 88 biological reactivity (all component materials)
• esterilidad: sterile; γ-irradiated
• Línea del producto: NovaSeptum^® GO
• Características: autoclavable: no
• Parámetros: -80-50 °C temp. range (-112-122 °F); 0.30 bar max. pressure (4.35 psi) at ±25 °C
• impurezas: <2.15 EU/device bacterial endotoxins (LAL test)
• aplicaciones: bioburden testing; cell therapy; gene therapy; life science and biopharma; mAb; ophthalmics; parenterals; pathogen testing; pharma/biopharma processes; sterile sampling; viral therapy
• temp. de almacenamiento: room temp

Descripción

Descripción general

Device configuration: Multi-sampling

The NovaSeptum^® GO bottle sampling unit is intended for applications where high purity, such as low endotoxin levels, is required. This sampling unit is available with a 2 mm needle and must be used with a NovaSeptum^® GO holder. The bio-neutral plastic bottles are ideal for all tests and available in a range of sizes. A closed, sterile sampling method can significantly reduce risk of cross contamination. Ideal for sampling from aseptic and sterile processes, the NovaSeptum^® GO sterile sampling system provides consistently representative samples, safely and securely.

Aplicación

Endotoxin
Bioburden - Archiving

Envase

E874-80060 (5x60 ml bottles, 5 units per box)
E874-80125 (5x125 ml bottles, 4 units per box)
E874-80250 (5x250 ml bottles, 3 units per box

Componentes

• Septum: Platinum-cured silicone
• Body: Polyester
• Cannula: ASTM^® 316 L Stainless steel
• Fluid contact layer (bottle): Polyethylene Terephtalate Glycol
• (Drainage bag): PureFlex^™ Polyethylene filmfilm)
• Tubing: Thermoplastic elastomer (TPE)
• Outlet Tubing: Cap

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

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

PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany