E711

NovaSeptum^® GO High Purity Bag Sampling System

sterile; β-irradiated

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

Properties

• material: 316 stainless steel cannula (ASTM^®); PureFlex^™ bag; TPE tubing (Thermoplastic elastomer); polyester body; 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: -20-50 °C temp. range (-4-122 °F) (for 100 mL); -80-50 °C temp. range (-112-122 °F) (for 50 mL to 250 mL (when used with a NovaSeptum^® Case)); 0.30 bar max. pressure (4.35 psi) (for 1000 mL); 0.50 bar max. pressure (7.25 psi) (up to 250 mL; 0.30 bar (4.35 psi) for 1000 mL)
• impurities: <2.15 EU/device bacterial endotoxins (LAL test)
• fitting: female Luer-Lok^® outlet (3-piece ); male Luer-Lok^® outlet (3-piece containing 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

Description

General description

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. NovaSeptum^® GO high purity bags for single sampling systems are available from 50 to 1000 mL.

Device configuration: single Unit Sampling

Application

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

Packaging

E711-10050 (50 ml bags, 50 units per box)
E711-10100 (100 ml bags, 50 units per box)
E711-10250 (250 ml bags, 50 units per box)
E711-11000 (1000 ml bags, 50 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.

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

PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany