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E9SU871

Millipore

NovaSeptum® GO Preloaded System with Bottle, 9-port

sterile; γ-irradiated

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Synonym(s):
NovaSeptum® GO Bottle

material

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

Quality Level

agency

according to ISO 11137 (sterilization)
meets ISO 146441
146441

meets ISO 88 biological reactivity (all component materials)

sterility

sterile; γ-irradiated

product line

NovaSeptum® GO

feature

autoclavable: no

parameter

-80-50 °C temp. range (-112-122 °F)
0.50 bar max. pressure (7.25 psi)

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

application(s)

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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This Item
E9SU221E5SU221E5SU871
feature

autoclavable: no

feature

autoclavable

feature

autoclavable

feature

autoclavable: no

agency

according to ISO 11137 (sterilization)

agency

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

agency

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

agency

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

sterility

sterile; γ-irradiated

sterility

sterile; β-irradiated

sterility

sterile; β-irradiated

sterility

sterile; γ-irradiated

product line

NovaSeptum® GO

product line

NovaSeptum® GO

product line

NovaSeptum® GO

product line

NovaSeptum® GO

parameter

-80-50 °C temp. range (-112-122 °F)

parameter

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

parameter

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

parameter

-80-50 °C temp. range (-112-122 °F), 0.50 bar max. pressure (7.25 psi)

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

Endotoxin
Bioburden - Archiving

Packaging

E9SU871-80060 (9x60 ml bottles, 3 units per box)
E9SU871-80125 (9x125 ml bottles, 2 units per box)
E9SU871-80250 (9x250 ml bottles, 1 units per box)

Components

  • Septum: Platinum-cured silicone
  • Body: Polyester
  • Cannula: ASTM® 316 L Stainless steel
  • Fluid contact layer (bottle): Polyethylene Terephtalate Glycol
  • Tubing: Thermoplastic elastomer (TPE)
  • Outlet Tubing: Cap

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
NOVASEPTIC is a registered trademark of Merck KGaA, Darmstadt, Germany
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany

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