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E711

Millipore

NovaSeptum® GO High Purity Bag Sampling System

sterile; β-irradiated

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Synonym(s):
NovaSeptum® GO High Purity Bag, Sterile_Sampling_Container

material

316 stainless steel cannula (ASTM®)
PureFlex bag
TPE tubing (Thermoplastic elastomer)
polyester body
silicone septum (platinum-cured)

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: no

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)

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
pathogen testing
pharma/biopharma processes
pyrogen testing
sterile sampling
sterility testing
viral therapy

storage temp.

room temp

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This Item
E221E9SU711E5SU711
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), meets ISO 146441
146441, meets ISO 88 biological reactivity (all component materials)

agency

according to ISO 11137 (sterilization), according to 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: no

feature

autoclavable

feature

autoclavable: no

feature

autoclavable: no

parameter

-20-50 °C temp. range (-4-122 °F) (for 100 mL)

parameter

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

parameter

-20-50 °C temp. range (-4-122 °F) (for 1000 mL), -80-50 °C temp. range (-112-122 °F) (for 50 mL to 250 mL), 0.30 bar max. pressure (4.35 psi) at ±25 °C (for 1000 mL), 0.50 bar max. pressure (7.25 psi) at ±25 °C (for up to 250 mL)

parameter

-80-50 °C temp. range (-112-122 °F), 0.50 bar max. pressure (7.25 psi) (for 1000 mL), 0.50 bar max. pressure (7.25 psi) (up to 250 mL)

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

E711-10050 (50 ml bags, 50 units per box)
E711-10100 (100 ml bags, 50 units per box)
E711-10250 (250 ml bags, 50 units per box)
E711-11000 (1000 ml bags, 50 units per box)

Components

  • 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

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
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany

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