E221

NovaSeptum^® GO Autoclavable Bag Sampling System, Vented

sterile; β-irradiated

• Synonym(s): NovaSeptum^® GO Autoclavable Bag, Vented
• UNSPSC Code: 41104105

Properties

• material: 316 stainless steel cannula; polyester body; polypropylene bag; silicone septum (platinum-cured); silicone tubing
• 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
• parameter: -20-125 °C temp. range (-4-257 °F); 0.30 bar max. pressure (4.35 psi)
• impurities: <2.15 EU/device bacterial endotoxins (LAL test)
• fitting: male Luer-Lok^® outlet (with female sterile vent filter)
• 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

The NovaSeptum^® GO autoclavable vented sampling unit is intended for applications where the unit is connected to a vessel that needs to be sterilized by autoclave. Available in 50 ml, 100 ml, 250 ml and 1000ml 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

Mobile Tanks
Autoclaved

Packaging

E221-00215 (50 ml bags, 40 units per box)
E221-00216 (100 ml bags, 40 units per box)
E221-C0243 (250 ml bags, 40 units per box)
E221-C0244 (1000 ml bags, 40 units per box)

Components

• Septum: Platinum-cured silicone
• Body: Polyester
• Cannula: ASTM^® 316 L Stainless steel
• Fluid contact layer (bag): Polypropylene film
• Tubing: Silicone
• Outlet Tubing: Male Luer-Lok^® with female sterile vent filter

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.

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