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
5 x 5 ml syringes, 5 units per box
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.
Other Notes
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®
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