E9SU461

NovaSeptum^® GO Preloaded System with Accurate Volume Syringe, 9-port

sterile; β-irradiated

• Synonym(s): NovaSeptum^® GO Accurate Volume Syringes
• UNSPSC Code: 41104105

Properties

• material: 316 stainless steel cannula; polycarbonate syringe (fluid contact layer); polyester body; silicone septum (platinum-cured ); silicone syringe (medical silicone fulid; fluid contact layer); silicone syringe (platinum-cured; fluid contact layer); silicone tubing
• Quality Level: 400
• 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: -80-121 °C temp. range (-112-250 °F) (for 20 ml); -80-134 °C temp. range (-112-250 °F) (for 5ml); 0.50 bar max. pressure (7.25 psi) at ±25 °C
• impurities: <2.15 EU/device bacterial endotoxins (LAL test)
• fitting: female Luer-Lok^® outlet; male Luer-Lok^® outlet
• application(s): 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
• 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

Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications

Packaging

E9SU461-90005 (9x5 ml syringes, 3 units per box)
E9SU461-90020 (9x20 ml syringes, 2 units per box)

Components

• Septum: Platinum-cured silicone
• Body: Polyester
• Cannula: ASTM^® 316 L Stainless steel
• Fluid contact layer (syringe): Polycarbonate, platinum-cured silicone, medical silicone fluid
• Tubing: Silicone
• Outlet Tubing: Female and male Luer-Lok^®

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