material
PureFlex™ polyethylene bag (film), polyester body, silicone septum (platinum-cured), silicone tubing, stainless steel body (ASTM® 316 L)
agency
according to ISO ISO 11137, meets USP 88 Biological Reactivity
sterility
sterile; β-irradiated
product line
NovaSeptum® GO
feature
autoclavable: no
parameter
-20-50 °C temp. range (-4-122 °F), 0.50 bar max. pressure (7.25 psi)
impurities
<2.15 bacterial endotoxins (LAL test, EU/device)
fitting
female Luer-Lok® outlet, male Luer-Lok® outlet
application(s)
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pharma/biopharma processes
sterile sampling
viral therapy
storage temp.
room temp
Quality Level
General description
A range of NovaSeptum® GO small pack size kits available to trial a sterile sampling solution for your process. Choose from several collection container types: high purity bags, autoclavable bags, bottles or accurate volume syringes (5 containers per pack). The closed, sterile sampling method can significantly reduce risk of cross contamination. Ideal for sampling from aseptic and sterile processes, the NovaSeptum® GO sterile sampling system provides consistently representative samples, safely and securely. NovaSeptum® GO Accurate Volume Syringes are designed to take samples from 1 mL to 20 mL, enabling operators to directly dispense sample products with milliliter accuracy. Autoclavable bags are intended for applications where the unit is connected to a vessel that needs to be sterilized by autoclave. Bio-neutral plastic bottles or high purity bags are ideal for all tests and are available in a range of sizes. Use a trial kit in combination with a NovaSeptum® GO holder.
Application
Sterile sampling
Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications
Packaging
Manifold, 5x 20ml syringes
Preparation Note
All component materials, in contact with sampling liquid, meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo.
Units are integrity tested at regular intervals during manufacturing.
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
Units are integrity tested at regular intervals during manufacturing.
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
Assembled under ISO Clean Room Class 8 conditions in a facility certified to ISO 14644-1 standards.
Other Notes
- Septum: Platinum-cured silicone; Body: Polyester; Cannula: ASTM® 316 L Stainless steel
- Drainage bag: Polyethylene film (PureFlex film)
- Fluid contact layer (syringe): Polycarbonate,
platinum-cured silicone, medical silicone fluid
- Tubing: Silicone
- Outlet Tubing: Female and male Luer-Lok®
Legal Information
ASTM is a registered trademark of American Society for Testing and Materials
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany
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Ensure sample integrity and accurate results with NovaSeptum® sterile sampling containers: bags, bottles, syringes & more.
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