DEM711-10250
Trial kit - NovaSeptum® GO; High Purity Bag Sampling System, 250ml
About This Item
Recommended Products
material
PureFlex™ polyethylene bag (Fluid contact layer, film)
TPE tubing (Thermoplastic elastomer)
polyester body
silicone septum (platinum-cured)
stainless steel body (ASTM® 316 L)
Quality Level
Agency
according to ISO ISO 11137
meets USP 88 Biological Reactivity
sterility
sterile; β-irradiated
product line
NovaSeptum® GO
feature
autoclavable: no
parameter
-20-50 °C temp. range (-4-122 °F) (1000 mL)
-80-50 °C temp. range (-112-122 °F) (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)
impurities
<2.15 bacterial endotoxins (LAL test, EU/device)
fitting
female Luer-Lok® outlet (3-piece)
male Luer-Lok® outlet (3-piece)
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
Application
Packaging
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
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