Quality Segment
material
316 stainless steel cannula (ASTM®), PETG bottle, TPE tubing, polyester body (platinum-cured), polyethylene bottle, silicone septum (platinum-cured)
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 tubing (cap)
application(s)
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pharma/biopharma processes
sterile sampling
viral therapy
storage temp.
room temp
General description
Device configuration: single unit sampling - preloaded system
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
sterile sampling
Packaging
E5SU871-80060 (5x60 ml bottles, 6 units per box)
E5SU871-80125 (5x125 ml bottles, 4 units per box)
E5SU871-80250 (5x250 ml bottles, 3 units per box)
E5SU871-80500 (5x500 ml bottles, 2 units per box)
E5SU871-80125 (5x125 ml bottles, 4 units per box)
E5SU871-80250 (5x250 ml bottles, 3 units per box)
E5SU871-80500 (5x500 ml bottles, 2 units per box)
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.
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
Other Notes
- Septum: Platinum-cured silicone
- Body: Polyester
- Cannula: ASTM® 316 L Stainless steel
- Fluid contact layer (bottle): Polyethylene Terephtalate Glycol
- Tubing: Thermoplastic elastomer (TPE)
- Outlet Tubing: Cap
Legal Information
ASTM is a registered trademark of American Society for Testing and Materials
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany