E5SU711

NovaSeptum^® GO Preloaded System with High Purity Bag, 5-port

sterile; β-irradiated

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

Properties

• material: 316 stainless steel cannula (ASTM^®); PureFlex^™ polyethylene bag; TPE tubing; polyester body (platinum-cured); silicone septum (platinum-cured)
• Quality Level: 400
• Agency: according to ISO 11137 (sterilization); according to ISO 146441; meets USP 88 Biological Reactivity (all component materials)
• sterility: sterile; β-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) (for 1000 mL); 0.50 bar max. pressure (7.25 psi) (up to 250 mL)
• impurities: <2.15 EU/device bacterial endotoxins (LAL test)
• fitting: female Luer-Lok^® outlet (3-piece with injection site); male Luer-Lok^® outlet (3-piece )
• application(s): cell therapy; gene therapy; life science and biopharma; mAb; ophthalmics; parenterals; pharma/biopharma processes; sterile sampling; viral therapy
• storage temp.: room temp

Description

General description

Device configuration: single unit sampling - preloaded system

TheNovaSeptum^® 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

sterile sampling

Packaging

E5SU711-10050 (5x50 ml bags, 8 units per box)
E5SU711-10100 (5x100 ml bags, 8 units per box)
E5SU711-10250 (5x250 ml bags, 7 units per box)
E5SU711-11000 (5x1000 ml bags, 6 units per box)

Components

• 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

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