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E871

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NovaSeptum® GO Bottle Sampling System

sterile; γ-irradiated

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Synonym(s):
NovaSeptum® GO Bottle

material

316 stainless steel cannula (ASTM®)
PETG bottle
PureFlex polyethylene bottle
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; 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 (Cap)

application(s)

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

storage temp.

room temp

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This Item
E5SU871E874E9SU221
material

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

material

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

material

316 stainless steel cannula, PureFlex polyethylene bag (drainage bag), TPE tubing, polyester body, polyethylene bottle (fluid contact layer), silicone septum (platinum-cured )

material

316 stainless steel cannula, polyester body, polyethylene bottle (fluid contact layer), silicone septum (platinum-cured ), silicone tubing

feature

autoclavable: no

feature

autoclavable: no

feature

autoclavable: no

feature

autoclavable

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), certified by the ISO 146441, meets USP 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; γ-irradiated

sterility

sterile; γ-irradiated

sterility

sterile; γ-irradiated

sterility

sterile; β-irradiated

product line

NovaSeptum® GO

product line

NovaSeptum® GO

product line

NovaSeptum® GO

product line

NovaSeptum® GO

General description

Device configuration: single Unit Sampling
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

Endotoxin
Bioburden -
Archiving

Packaging

E871-80060 (60 ml bottle, 40 units per box)
E871-80125 (125 ml bottle, 25 units per box)
E871-80250 (250 ml bottle, 20 units per box)
E871-80500 (500 ml bottle, 12 units per box)

Components

  • Septum: Platinum-cured silicone
  • Body: Polyester
  • Cannula: ASTM® 316 L Stainless steel
  • Fluid contact layer (bottle): Polyethylene Terephtalate Glycol(PETG)
  • Tubing: Thermoplastic elastomer (TPE)
  • Outlet Tubing: Cap

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
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany

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