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Merck
CN

E711-10100

NovaSeptum® GO Sampling Unit; High Purity Application

Single; 100mL

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UNSPSC Code:
41104105

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material

316 stainless steel cannula (ASTM®), PureFlex™ bag, 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; β-irradiated

product line

NovaSeptum® GO

feature

autoclavable: no

parameter

-20-50 °C temp. range (-4-122 °F) (up to -80°C/-112°F when used with a NovaSeptum® Case), 0.50 bar max. pressure (7.25 psi)

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

fitting

female Luer-Lok® outlet (3-piece), male Luer-Lok® outlet (3-piece containing an injection site)

application(s)

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

storage temp.

room temp

Quality Level

400

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General description

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. NovaSeptum® GO high purity bags for single sampling systems are available from 50 to 1000 mL.
Device configuration: single Unit Sampling

Application

Regular Sampling Sample (with or without protective case).
Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications.

Packaging

100 ml bags, 50 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 (bag): Polyethylene film (PureFlex™ film)
  • Tubing: Thermoplastic elastomer (TPE)
  • Outlet Tubing: 3-piece Luer-Lok®, containing a male, female and an injection site

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany

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