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), 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)
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.
room temp
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
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