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Safety Information

E221

Millipore

NovaSeptum® GO Autoclavable Bag Sampling System, Vented

sterile; β-irradiated

Synonym(s):

NovaSeptum® GO Autoclavable Bag, Vented

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About This Item

UNSPSC Code:
41104105

material

316 stainless steel cannula
polyester body
polypropylene bag
silicone septum (platinum-cured)
silicone tubing

Quality Level

400

Agency

according to ISO 11137 (sterilization)
according to ISO 146441
meets USP 88 Biological Reactivity (all component materials)

sterility

sterile; β-irradiated

product line

NovaSeptum® GO

feature

autoclavable

parameter

-20-125 °C temp. range (-4-257 °F)
0.30 bar max. pressure (4.35 psi)

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

fitting

male Luer-Lok® outlet (with female sterile vent filter)

application(s)

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

storage temp.

room temp

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General description

Device configuration: single unit sampling
The NovaSeptum® GO autoclavable vented sampling unit is intended for applications where the unit is connected to a vessel that needs to be sterilized by autoclave. Available in 50 ml, 100 ml, 250 ml and 1000ml 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

Mobile Tanks
Autoclaved

Packaging

E221-00215 (50 ml bags, 40 units per box)
E221-00216 (100 ml bags, 40 units per box)
E221-C0243 (250 ml bags, 40 units per box)
E221-C0244 (1000 ml bags, 40 units per box)

Components

  • Septum: Platinum-cured silicone
  • Body: Polyester
  • Cannula: ASTM® 316 L Stainless steel
  • Fluid contact layer (bag): Polypropylene film
  • Tubing: Silicone
  • Outlet Tubing: Male Luer-Lok® with female sterile vent filter

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
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany

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Regulatory Information

新产品

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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