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UNSPSC Code:
41104105
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material

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

Quality Level

Agency

ISO 10993-5 (all component materials)
USP 87 Cytotoxicity Elution Test (In Vitro)
according to ISO 11137 (sterilization)
according to ISO 146441
meets the criteria for Biological Reactivity Testing: can be any one or a combination of the following test methods USP<88> Systemic Injection Test (In Vivo)

sterility

sterile; γ-irradiated

product line

NovaSeptum® GO

feature

autoclavable: no

parameter

-80-50 °C temp. range (-112-122 °F) (Freeze sampling bottle vertically)
0.30 bar max. pressure (4.35 psi)

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

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

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

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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