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Merck
CN

E9SU461

NovaSeptum® GO Preloaded System with Accurate Volume Syringe, 9-port

sterile; β-irradiated

Synonym(s):

NovaSeptum® GO Accurate Volume Syringes

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About This Item

UNSPSC Code:
41104105

Key Documents

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material

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

agency

according to ISO 11137 (sterilization), certified by the ISO 146441, meets USP 88 biological reactivity (all component materials)

sterility

sterile; β-irradiated

product line

NovaSeptum® GO

feature

autoclavable

parameter

-80-121 °C temp. range (-112-250 °F) (for 20 ml), -80-134 °C temp. range (-112-250 °F) (for 5ml), 0.50 bar max. pressure (7.25 psi) at ±25 °C

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

fitting

female Luer-Lok® outlet, male Luer-Lok® outlet

storage temp.

room temp

Quality Level

400

application(s)

cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pharma/biopharma processes
pyrogen testing
sterile sampling
sterility testing
viral therapy

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General description

Device configuration: Single Unit Sampling - Pre-loaded system
The NovaSeptum® GO pre-loaded disposable magazine is available with various standard configurations using NovaSeptum® GO high purity bags, autoclavable bags, bottles, transfer tubes or accurate volume (AV) syringe units. Other configurations are available upon request. For an optimal aseptic solution, use the NovaSeptum®GO pre-loaded disposable magazine together with a 1.5" or 2" NovAseptic® connector and NovaSeptum® GO pre-loaded starter kit (5/9 shot stainless steel base). 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

E9SU461-90005 (9x5 ml syringes, 3 units per box)
E9SU461-90020 (9x20 ml syringes, 2 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
  • Fluid contact layer (syringe): Polycarbonate, platinum-cured silicone, medical silicone fluid
  • Tubing: Silicone
  • Outlet Tubing: Female and male Luer-Lok®

Legal Information

Luer-Lok is a registered trademark of Becton-Dickinson & Co.
NOVASEPTIC is a registered trademark of Merck KGaA, Darmstadt, Germany
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
ASTM is a registered trademark of American Society for Testing and Materials

Regulatory Information

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