E711
NovaSeptum® GO High Purity Bag Sampling System
sterile; β-irradiated
Synonym(s):
NovaSeptum® GO High Purity Bag, Sterile_Sampling_Container
About This Item
Recommended Products
material
316 stainless steel cannula (ASTM®)
PureFlex™ bag
TPE tubing (Thermoplastic elastomer)
polyester body
silicone septum (platinum-cured)
Quality Level
Agency
according to ISO 11137 (sterilization)
according to ISO 146441
meets USP 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 100 mL)
-80-50 °C temp. range (-112-122 °F) (for 50 mL to 250 mL (when used with a NovaSeptum® Case))
0.30 bar max. pressure (4.35 psi) (for 1000 mL)
0.50 bar max. pressure (7.25 psi) (up to 250 mL
0.30 bar (4.35 psi) for 1000 mL)
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
pathogen testing
pharma/biopharma processes
pyrogen testing
sterile sampling
sterility testing
viral therapy
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Related Categories
1 of 4
This Item | P6556 | SRE0047 | P8044 |
|---|---|---|---|
| specific activity ≥30 units/mg protein | specific activity ≥30 units/mg protein | specific activity ≥30 units/mg protein | specific activity ≥3.0 unit/mg solid |
| form lyophilized powder | form lyophilized powder | form lyophilized powder | form lyophilized powder |
| storage temp. −20°C | storage temp. −20°C | storage temp. −20°C | storage temp. −20°C |
| shipped in wet ice | shipped in wet ice | shipped in wet ice | shipped in - |
| mol wt 28.93 kDa | mol wt 28.93 kDa | mol wt 28.93 kDa | mol wt 28.93 kDa |
General description
Application
Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications.
Packaging
E711-10100 (100 ml bags, 50 units per box)
E711-10250 (250 ml bags, 50 units per box)
E711-11000 (1000 ml bags, 50 units per box)
Components
- 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
Preparation Note
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
Legal Information
Regulatory Information
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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