material
316 stainless steel cannula
PureFlex™ polyethylene bag (drainage bag)
TPE tube
polyester body
polyethylene bottle (fluid contact layer)
silicone septum (platinum-cured)
Quality Level
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; γ-irradiated
product line
NovaSeptum® GO
feature
autoclavable: no
parameter
-80-50 °C temp. range (-112-122 °F) (Freeze sampling bottle vertically)
0.30 bar max. pressure (4.35 psi)
impurities
<2.15 EU/device bacterial endotoxins (LAL test)
application(s)
bioburden testing
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
Components
- Septum: Platinum-cured silicone
- Body: Polyester
- Cannula: ASTM® 316 L Stainless steel
- Fluid contact layer (bottle): Polyethylene Terephtalate Glycol
- (Drainage bag): PureFlex™ Polyethylene filmfilm)
- Tubing: Thermoplastic elastomer (TPE)
- Outlet Tubing: Cap
Preparation Note
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
Legal 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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