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E5SU871

NovaSeptum® GO Preloaded System with Bottle, 5-port

sterile; γ-irradiated

Synonym(s):

NovaSeptum® GO Bottle, Sterile_Sampling_Container

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About This Item

UNSPSC Code:
41104105
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Quality Segment

400

material

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

agency

according to ISO 11137 (sterilization), according to 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), 0.50 bar max. pressure (7.25 psi)

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

fitting

outlet tubing (cap)

application(s)

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

storage temp.

room temp

General description

Device configuration: single unit sampling - preloaded system
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

sterile sampling

Packaging

E5SU871-80060 (5x60 ml bottles, 6 units per box)
E5SU871-80125 (5x125 ml bottles, 4 units per box)
E5SU871-80250 (5x250 ml bottles, 3 units per box)
E5SU871-80500 (5x500 ml bottles, 2 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
  • 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

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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