E9SU711

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

sterile; β-irradiated

• Synonym(s): NovaSeptum^® GO High Purity Bag, Sterile_Sampling_Container
• UNSPSC Code: 41104105

Properties

• Product Name: NovaSeptum^® GO Preloaded System with High Purity Bag, 9-port, sterile; β-irradiated
• material: 316 stainless steel cannula; PureFlex^™ polyethylene bag (fluid contact layer); TPE tubing; polyester body; silicone septum (platinum-cured)
• agency: according to ISO 11137 (sterilization); meets ISO 146441; 146441; meets ISO 88 biological reactivity (all component materials)
• sterility: sterile; β-irradiated
• product line: NovaSeptum^® GO
• feature: autoclavable: no
• parameter: -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)
• impurities: <2.15 EU/device bacterial endotoxins (LAL test)
• fitting: 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)
• 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
• Quality Level: 400

Description

Application

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

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.

Other Notes

• 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

Packaging

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)

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

PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany