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Merck
CN

DEM511-10014

Trial kit - NovaSeptum® GO; Transfer Tube TPE 500mm

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About This Item

UNSPSC Code:
60104202

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material

C-Flex tubing (tube), TPE tubing (Thermoplastic elastomer), polyester body, silicone septum (platinum-cured), silicone tubing, stainless steel body (ASTM® 316 L)

agency

according to ISO ISO 11137, meets USP 88 Biological Reactivity

sterility

sterile; β-irradiated

product line

NovaSeptum® GO

feature

autoclavable: no

parameter

-20-50 °C temp. range (-4-122 °F) (Thermoplastic elastomer (TPE)), -50-95 °C temp. range (-58-203 °F) (Silicone), -73-132 °C temp. range (-99-270 °F) (C-Flex®), 0.50 bar max. pressure (7.25 psi)

impurities

<2.15 bacterial endotoxins (LAL test, EU/device)

fitting

female Luer-Lok® outlet (3-piece), male Luer-Lok® outlet (3-piece)

application(s)

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

storage temp.

room temp

Quality Level

400

Related Categories

General description

A range of NovaSeptum® GO small pack size kits available to trial a sterile sampling solution for your process. Choose from several collection container types: high purity bags, autoclavable bags, bottles or accurate volume syringes (5 containers per pack). The 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 Accurate Volume Syringes are designed to take samples from 1 mL to 20 mL, enabling operators to directly dispense sample products with milliliter accuracy. Autoclavable bags are intended for applications where the unit is connected to a vessel that needs to be sterilized by autoclave. Bio-neutral plastic bottles or high purity bags are ideal for all tests and are available in a range of sizes. Use a trial kit in combination with a NovaSeptum® GO holder.

Application

Sterile sampling
Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications

Packaging

5x TPE tube 500mm

Preparation Note

All component materials, in contact with sampling liquid, meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo.
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.
Assembled under ISO Clean Room Class 8 conditions in a facility certified to ISO 14644-1 standards.

Other Notes

  • Septum: Platinum-cured silicone; Body: Polyester
  • Cannula: ASTM® 316 L Stainless steel
  • Tubing: Thermoplastic elastomer (TPE), silicone or C-Flex® tube
  • 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
C-Flex is a registered trademark of Saint-Gobain Performance Plastics Corp.
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany

Regulatory Information

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