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Safety Information

E714

Millipore

NovaSeptum® GO High Purity Bag Sampling System, Manifold (5-valve)

sterile; β-irradiated

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Synonym(s):
NovaSeptum® GO High Purity Bag

material

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

Quality Level

400

Agency

according to ISO 11137 (sterilization)
according to ISO 146441
meets USP 88 biological reactivity
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)

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)
 male Luer-Lok® outlet (3-piece)

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

Related Categories

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 multi-sampling systems are available from 50 to 250 mL.
Device configuration: Multi-sampling

Application

Regular Sampling Sample (with or without protective case).
Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications.

Packaging

E714-10050 (5x50 ml bags, 5 units per box)
E714-10100 (5x100 ml bags, 5 units per box)
E714-10250 (5x250 ml bags, 5 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

Regulatory Information

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