E874

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

sterile; γ-irradiated

• Synonym(s): NovaSeptum^® GO Bottle
• UNSPSC Code: 41104105

Properties

• material: 316 stainless steel cannula; PureFlex^™ polyethylene bag (drainage bag); TPE tubing; polyester body; polyethylene bottle (fluid contact layer); silicone septum (platinum-cured )
• Quality Level: 400
• agency: according to ISO 11137 (sterilization); certified by the ISO 146441; meets USP 88 biological reactivity (all component materials)
• sterility: sterile; γ-irradiated
• product line: NovaSeptum^® GO
• feature: autoclavable: no
• parameter: -80-50 °C temp. range (-112-122 °F); 0.30 bar max. pressure (4.35 psi) at ±25 °C
• impurities: <2.15 EU/device bacterial endotoxins (LAL test)
• 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

Description

General description

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.

Application

Endotoxin
Bioburden - Archiving

Packaging

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

Components

• 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

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

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

PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany