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Safety Information

E874

Millipore

NovaSeptum® GO Bottle Sampling System, Manifold (5-valve)

sterile; γ-irradiated

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Synonym(s):
NovaSeptum® GO Bottle

material

316 stainless steel cannula
PureFlex™ polyethylene bag (drainage bag)
TPE tubing
polyester body
polyethylene bottle (fluid contact layer)
silicone septum (platinum-cured )

Quality Level

400

Agency

according to ISO 11137 (sterilization)
certified by the ISO 146441
meets USP 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)
0.30 bar max. pressure (4.35 psi) at ±25 °C

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

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

Related Categories

General description

Device configuration: Multi-sampling
The NovaSeptum® GO bottle sampling unit is intended for applications where high purity, such as low endotoxin levels, is required. This sampling unit is available with a 2 mm needle and must be used with a NovaSeptum® GO holder. The bio-neutral plastic bottles are ideal for all tests and available in a range of sizes. 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

Endotoxin
Bioburden - Archiving

Packaging

E874-80060 (5x60 ml bottles, 5 units per box)
E874-80125 (5x125 ml bottles, 4 units per box)
E874-80250 (5x250 ml bottles, 3 units per box

Components

  • Septum: Platinum-cured silicone
  • Body: Polyester
  • Cannula: ASTM® 316 L Stainless steel
  • Fluid contact layer (bottle): Polyethylene Terephtalate Glycol
  • (Drainage bag): PureFlex™ Polyethylene filmfilm)
  • 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
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany

Regulatory Information

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