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Merck
CN

E9SU221

NovaSeptum® GO Preloaded System with Autoclavable Bag, Vented, 9-port,

sterile; β-irradiated

别名:

NovaSeptum® GO Autoclavable Bag, Vented, Sterile_Sampling_Container

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UNSPSC Code:
41104105

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产品名称

NovaSeptum® GO Preloaded System with Autoclavable Bag, Vented, 9-port,, sterile; β-irradiated

Quality Level

400

material

316 stainless steel cannula
polyester body
polyethylene bottle (fluid contact layer)
silicone septum (platinum-cured )
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

-20-125 °C temp. range (-4-257 °F)
0.30 bar max. pressure (4.35 psi) at ±25 °C

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

fitting

male Luer-Lok® outlet (with female sterile vent filter)

application(s)

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

storage temp.

room temp

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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

Mobile Tanks
Autoclaved

Other Notes

  • Septum: Platinum-cured silicone
  • Body: Polyester
  • Cannula: ASTM® 316 L Stainless steel
  • Fluid contact layer (bag): Polypropylene film
  • Tubing: Silicone
  • Outlet Tubing: Male Luer-Lok® with female sterile vent filter

Packaging

E9SU221-00215 (9x50 ml bags, 3 units per box)
E9SU221-00216 (9x100 ml bags, 3 units per box)
E9SU221-C0243 (9x250 ml bags, 3 units per box)
E9SU221-C0244 (9x1000 ml bags, 3 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.

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

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