产品名称
NovaSeptum® GO Preloaded System with High Purity Bag, 9-port, sterile; β-irradiated
material
316 stainless steel cannula
PureFlex™ polyethylene bag (fluid contact layer)
TPE tubing
polyester body
silicone septum (platinum-cured)
agency
according to ISO 11137 (sterilization)
meets ISO 146441
146441
meets ISO 88 biological reactivity (all component materials)
sterility
sterile; β-irradiated
product line
NovaSeptum® GO
feature
autoclavable: no
parameter
-20-50 °C temp. range (-4-122 °F) (for 1000 mL)
-80-50 °C temp. range (-112-122 °F) (for 50 mL to 250 mL)
0.30 bar max. pressure (4.35 psi) at ±25 °C (for 1000 mL)
0.50 bar max. pressure (7.25 psi) at ±25 °C (for up to 250 mL)
impurities
<2.15 EU/device bacterial endotoxins (LAL test)
fitting
female Luer-Lok® outlet (3-piece)
male Luer-Lok® outlet (3-piece)
male Luer-Lok® outlet (3-piece, containing a male, female and an injection site)
application(s)
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pathogen testing
pathogen testing
pharma/biopharma processes
pyrogen testing
sterile sampling
sterility testing
viral therapy
storage temp.
room temp
Quality Level
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Application
Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications
General description
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
Packaging
E9SU711-10100 (9x100 ml bags, 3 units per box)
E9SU711-10250 (9x250 ml bags, 3 units per box)
E9SU711-11000 (9x1000 ml bags, 3 units per box)
Preparation Note
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
Legal Information
法规信息
相关内容
Product Descriptions
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