E9SU871
NovaSeptum® GO Preloaded System with Bottle, 9-port
sterile; γ-irradiated
Synonym(s):
NovaSeptum® GO Bottle
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About This Item
Quality Segment
material
316 stainless steel cannula, PETG bottle (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; 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)
application(s)
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pathogen testing
pharma/biopharma processes
sterile sampling
viral therapy
storage temp.
room temp
General description
Application
Bioburden - Archiving
Packaging
E9SU871-80125 (9x125 ml bottles, 2 units per box)
E9SU871-80250 (9x250 ml bottles, 1 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 | |||
|---|---|---|---|
| description sterile; γ-irradiated | description sterile; β-irradiated | description sterile; β-irradiated | description sterile; β-irradiated |
| material PETG bottle (fluid contact layer), silicone septum (platinum-cured), 316 stainless steel cannula, polyester body, TPE tubing | material PureFlex™ polyethylene bag (fluid contact layer), polyester body, silicone septum (platinum-cured), 316 stainless steel cannula, TPE tubing | material polyester body (platinum-cured), PureFlex™ polyethylene bag, TPE tubing, 316 stainless steel cannula (ASTM®), silicone septum (platinum-cured) | material polyester body (platinum-cured), silicone septum (platinum-cured), polycarbonate syringe (fluid contact layer), 316 stainless steel cannula (ASTM®), silicone syringe (platinum-cured silicone, medical fluid contact layer), silicone tubing |
| application(s) cell therapy | application(s) cell therapy | application(s) cell therapy | application(s) cell therapy |
| sterility sterile; γ-irradiated | sterility sterile; β-irradiated | sterility sterile; β-irradiated | sterility sterile; β-irradiated |
| product line NovaSeptum® GO | product line NovaSeptum® GO | product line NovaSeptum® GO | product line NovaSeptum® GO |
| parameter -80-50 °C temp. range (-112-122 °F), 0.50 bar max. pressure (7.25 psi) | parameter 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), -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) | parameter 0.50 bar max. pressure (7.25 psi) (up to 250 mL), 0.50 bar max. pressure (7.25 psi) (for 1000 mL), -80-50 °C temp. range (-112-122 °F) | parameter 0.50 bar max. pressure (7.25 psi), -80-134 °C temp. range (-112-273 °F) ( |
| agency meets ISO 88 biological reactivity (all component materials), meets ISO 146441 | agency meets ISO 88 biological reactivity (all component materials), meets ISO 146441 | agency meets USP 88 Biological Reactivity (all component materials), according to ISO 146441, according to ISO 11137 (sterilization) | agency according to ISO 146441, meets USP 88 Biological Reactivity (all component materials), according to ISO 11137 (sterilization) |
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