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E461

Millipore

NovaSeptum® GO Accurate Volume Syringe Sampling System

sterile; β-irradiated

Synonym(s):
NovaSeptum GO Accurate Volume Syringes

material

316 stainless steel cannula
polycarbonate syringe (fluid contact layer)
polyester body
silicone septum (platinum-cured)
silicone syringe (medical fluid contact layer; platinum cured silicone)
silicone tubing

Quality Level

Agency

according to ISO 11137 (sterilization)
according to ISO 146441
meets USP 88 Biological Reactivity (all component materials)

sterility

sterile; β-irradiated

feature

autoclavable

parameter

-80-121 °C temp. range (-112-250 °F) (20ml)
-80-134 °C temp. range (-112-273 °F) (5ml)
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)

pathogen testing
pathogen testing
pyrogen testing
sterility testing

storage temp.

room temp

Related Categories

General description

Device configuration: single unit sampling
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. For sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis and fermentation applications. 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, and fermentation applications

Packaging

E461-90005 (5 ml syringes, 50 units per box)
E461-90020 (20 ml syringes, 40 units per box)

Components

  • Septum: Platinum-cured silicone
  • Body: Polyester
  • Cannula: ASTM® 316 L Stainless steel
  • 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 Millipore AB - Sweden

Certificate of Analysis

Enter Lot Number to search for Certificate of Analysis (COA).

Certificate of Quality

Enter Lot Number to search for Certificate of Quality (COQ).

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