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Merck
CN

E871-80125

NovaSeptum® GO Sampling Unit; Bottle Application

Single; 125mL

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UNSPSC Code:
41104105

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material

316 stainless steel cannula (ASTM®), PETG bottle, PureFlex™ polyethylene bottle, TPE tubing (Thermoplastic elastomer), polyester body, silicone septum (platinum-cured)

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), 0.50 bar max. pressure (7.25 psi)

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

fitting

outlet (Cap)

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

Quality Level

400

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General description

Device configuration: single Unit 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

125 ml bottle, 25 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 (bottle): Polyethylene Terephtalate Glycol(PETG)
  • Tubing: Thermoplastic elastomer (TPE)
  • Outlet Tubing: Cap

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

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