产品名称
NovaSeptum® SURe Sampling Unit; Bottle Application, 5x60mL; Inlet C-Flex® Tubing
material
C-Flex tubing, PETG body, PETG container, TPE tubing, polycarbonate Luer lock
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® SURe
feature
autoclavable: no
storage condition
room temperature
parameter
-80-50 °C temp. range (-112-122 °F) (Freeze sampling bottle vertically), 0.30 bar max. pressure (4.35 psi)
capacity
60 mL
volume
60 mL
impurities
<2.15 EU/device bacterial endotoxins (LAL test)
fitting
Luer-Lok® inlet connection (3-piece), inlet connection (containing a male, female and an injection site), Luer-Lok® outlet connection (3-piece), outlet connection (containing a male, female and an injection site)
application(s)
sterile sampling
storage temp.
10-30°C
General description
The product comes as a manifolded unit with 5 bottles and connects via C-flex® tubing for thermowelding. The bio-neutral plastic bottles are ideal for all tests. The closed design ensures your sample will be isolated from point of sample to analysis, reducing the risk of losing valuable product and maintaining the integrity of your fluid samples.
Application
Features and Benefits
- Product design ensures process integrity and a representative sample from single-use manufacturing processes
- Industry-standard aseptic connection and disconnection for easy integration into your single-use process
- Other container options available: bags, bottles, syringes, and conical tubes
- Stocked and ready-to-ship for fast delivery
Packaging
Preparation Note
Analysis Note
Other Notes
- Inlet tubing: C-Flex®
- Fluid contact layer (bottle): Polyethylene Terephtalate Glycol
- (Drainage bag): PureFlex™ Polyethylene film
- Tubing: Thermoplastic elastomer (TPE)
- Outlet Tubing: Cap
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