E464

NovaSeptum^® GO Accurate Volume Syringe Sampling System, Manifold (5-valve)

sterile; β-irradiated

• Synonym(s): NovaSeptum^® GO Accurate Volume Syringes
• UNSPSC Code: 41104105

Properties

• material: 316 stainless steel cannula; PureFlex^™ polyethylene bag (Drainage bag); polycarbonate syringe (fluid contact layer); polyester body; silicone septum (platinum-cured); silicone syringe (medical fluid contact layer; platinum cured silicone); 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: no
• parameter: -20-50 °C temp. range (-4-122 °F); 0.50 bar max. pressure (7.25 psi)
• impurities: <2.15 EU/device bacterial endotoxins (LAL test)
• fitting: female Luer-Lok^® outlet; male Luer-Lok^® outlet
• 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

Device configuration: multiple sampling

The NovaSeptum^® GO Accurate volume syringes are used in critical sampling operation in Biopharma environment where high value drugs are manufactured and where material waste downsizing is at utmost importance.
NovaSeptum^® GO Accurate Volume Syringes are designed to take samples from 1 mL to 20 mL, enabling operators to directly dispense sample products with milliliter accuracy. The ability to accurately measure the sample taken is particularly important for sampling of high value products and reduces expensive product waste. The syringes are ideal for storage. 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

Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, sterile sampling, and fermentation applications

Packaging

E464-90005 (5 x 5 ml syringes, 5 units per box)
E464-90020 (5 x 20 ml syringes, 5 units per box)

Components

• Septum: Platinum-cured silicone
• Body: Polyester
• Cannula: ASTM^® 316 L Stainless steel
• Drainage bag: Polyethylene film (PureFlex^™ film)
• Fluid contact layer (syringe): Polycarbonate, platinum-cured silicone, medical silicone fluid
• Tubing: Silicone
• Outlet Tubing: Female and male Luer-Lok^®

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