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E5SU461

NovaSeptum® GO Preloaded System with Accurate Volume Syringe, 5-port

sterile; β-irradiated

Synonym(s):

NovaSeptum® GO Accurate Volume Syringes

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About This Item

UNSPSC Code:
41104105
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Quality Segment

400

material

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

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

parameter

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

application(s)

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

storage temp.

room temp

General description

Device configuration: single unit sampling - preloaded 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

sterile sampling

Packaging

E5SU461-90005 (5x5 ml syringes, 6 units per box)
E5SU461-90020 (5x20 ml syringes, 4 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

ASTM is a registered trademark of American Society for Testing and Materials
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

Regulatory Information

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Articles

Containers for Closed Sterile Sampling

Ensure sample integrity and accurate results with NovaSeptum® sterile sampling containers: bags, bottles, syringes & more.

Global Trade Item Number

SKUGTIN
E5SU461-9002004061841097976
E5SU461-9000504061841097983