Quality Segment
material
316 stainless steel cannula (ASTM®), PureFlex™ bag, TPE tubing (Thermoplastic elastomer), polyester body, silicone septum (platinum-cured)
agency
ISO 10993-5 (all component materials), USP 87 Cytotoxicity Elution Test (In Vitro), according to ISO 11137 (sterilization), according to ISO 146441, meets the criteria for Biological Reactivity Testing: can be any one or a combination of the following test methods USP<88> Systemic Injection Test (In Vivo)
sterility
sterile; β-irradiated
product line
NovaSeptum® GO
feature
autoclavable: no
parameter
-20-50 °C temp. range (-4-122 °F) (up to -80°C/-112°F when used with a NovaSeptum® Case), 0.50 bar max. pressure (7.25 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)
application(s)
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pathogen testing
pharma/biopharma processes
pyrogen testing
sterile sampling
sterility testing
viral therapy
storage temp.
10-30°C
General description
Application
Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications.
Packaging
Preparation Note
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 (bag): Polyethylene film (PureFlex™ film)
- Tubing: Thermoplastic elastomer (TPE)
- Outlet Tubing: 3-piece Luer-Lok®, containing a male, female and an injection site
Legal Information
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