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E221

Millipore

NovaSeptum® GO Autoclavable Bag Sampling System, Vented

sterile; β-irradiated

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Synonym(s):
NovaSeptum® GO Autoclavable Bag, Vented

material

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

Quality Level

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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This Item
E711E714E9SU221
agency

according to ISO 11137 (sterilization)

agency

according to ISO 11137 (sterilization), according to ISO 146441, meets USP 88 biological reactivity (all component materials)

agency

according to ISO 11137 (sterilization), according to ISO 146441, meets USP 88 biological reactivity
88 biological reactivity (all component materials)

agency

according to ISO 11137 (sterilization), certified by the ISO 146441, meets USP 88 biological reactivity (all component materials)

sterility

sterile; β-irradiated

sterility

sterile; β-irradiated

sterility

sterile; β-irradiated

sterility

sterile; β-irradiated

product line

NovaSeptum® GO

product line

NovaSeptum® GO

product line

NovaSeptum® GO

product line

NovaSeptum® GO

feature

autoclavable

feature

autoclavable: no

feature

autoclavable: no

feature

autoclavable

parameter

-20-125 °C temp. range (-4-257 °F)

parameter

-20-50 °C temp. range (-4-122 °F) (for 100 mL), -80-50 °C temp. range (-112-122 °F) (for 50 mL to 250 mL (when used with a NovaSeptum® Case)), 0.30 bar max. pressure (4.35 psi) (for 1000 mL), 0.50 bar max. pressure (7.25 psi) (up to 250 mL
0.30 bar (4.35 psi) for 1000 mL)

parameter

-20-50 °C temp. range (-4-122 °F) (for 100 mL), -80-50 °C temp. range (-112-122 °F) (for 50 mL to 250 mL (when used with a NovaSeptum® Case)), 0.30 bar max. pressure (4.35 psi)

parameter

-20-125 °C temp. range (-4-257 °F), 0.30 bar max. pressure (4.35 psi) at ±25 °C

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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