E9SU871

NovaSeptum^® GO Preloaded System with Bottle, 9-port

sterile; γ-irradiated

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

Properties

• material: 316 stainless steel cannula; PETG bottle (fluid contact layer); TPE tubing; polyester body; silicone septum (platinum-cured)
• Quality Level: 400
• Agency: according to ISO 11137 (sterilization); meets ISO 146441; 146441; meets ISO 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); 0.50 bar max. pressure (7.25 psi)
• impurities: <2.15 EU/device bacterial endotoxins (LAL test)
• application(s): 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: 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.

Application

Endotoxin
Bioburden - Archiving

Packaging

E9SU871-80060 (9x60 ml bottles, 3 units per box)
E9SU871-80125 (9x125 ml bottles, 2 units per box)
E9SU871-80250 (9x250 ml bottles, 1 units per box)

Components

• Septum: Platinum-cured silicone
• Body: Polyester
• Cannula: ASTM^® 316 L Stainless steel
• Fluid contact layer (bottle): Polyethylene Terephtalate Glycol
• 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

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

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