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About This Item
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
Application
Packaging
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
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
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This Item | |||
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| description sterile; γ-irradiated | description sterile; γ-irradiated | description sterile; β-irradiated | description sterile; β-irradiated |
| material TPE tubing, polyethylene bottle, silicone septum (platinum-cured), polyester body (platinum-cured), 316 stainless steel cannula (ASTM®), PETG bottle | material TPE tubing, silicone septum (platinum-cured), polyester body, 316 stainless steel cannula, PETG bottle (fluid contact layer) | material polycarbonate syringe (fluid contact layer), silicone septum (platinum-cured), 316 stainless steel cannula (ASTM®), polyester body (platinum-cured), silicone tubing, silicone syringe (platinum-cured silicone, medical fluid contact layer) | material 316 stainless steel cannula (ASTM®), silicone septum (platinum-cured), PureFlex™ polyethylene bag, TPE tubing, polyester body (platinum-cured) |
| fitting outlet tubing (cap) | fitting - | fitting male Luer-Lok® outlet tubing, female Luer-Lok® outlet | fitting female Luer-Lok® outlet (3-piece with injection site), male Luer-Lok® outlet (3-piece ) |
| application(s) cell therapy | application(s) cell therapy | application(s) cell therapy | application(s) cell therapy |
| parameter 0.50 bar max. pressure (7.25 psi), -80-50 °C temp. range (-112-122 °F) | parameter -80-50 °C temp. range (-112-122 °F), 0.50 bar max. pressure (7.25 psi) | parameter 0.50 bar max. pressure (7.25 psi), -80-134 °C temp. range (-112-273 °F) ( | parameter -80-50 °C temp. range (-112-122 °F), 0.50 bar max. pressure (7.25 psi) (up to 250 mL), 0.50 bar max. pressure (7.25 psi) (for 1000 mL) |
| product line NovaSeptum® GO | product line NovaSeptum® GO | product line NovaSeptum® GO | product line NovaSeptum® GO |
| sterility sterile; γ-irradiated | sterility sterile; γ-irradiated | sterility sterile; β-irradiated | sterility sterile; β-irradiated |
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