E714

NovaSeptum^® GO High Purity Bag Sampling System, Manifold (5-valve)

sterile; β-irradiated

• Synonyma: NovaSeptum^® GO High Purity Bag
• UNSPSC Code: 41104105

Vlastnosti

• material: 316 stainless steel cannula (ASTM^®); PureFlex^™ polyethylene 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; 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)
• 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); male Luer-Lok^® outlet (3-piece)
• 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

Popis

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 multi-sampling systems are available from 50 to 250 mL.

Device configuration: Multi-sampling

Application

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

Packaging

E714-10050 (5x50 ml bags, 5 units per box)
E714-10100 (5x100 ml bags, 5 units per box)
E714-10250 (5x250 ml bags, 5 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