material
TPE tubing, polycarbonate connector (
), polyethylene body, PETG container
Quality Segment
sterility
sterile; γ-irradiated
product line
NovaSeptum® SURe
storage condition
room temperature
parameter
0.5 bar max. pressure (7.25 psi), 4-40 °C temp. range (39-104 °F)
fitting
inlet connection (TPE), Luer-Lok® outlet connection (3 piece), outlet connection (containing a male, female and an injection site)
application(s)
sterile sampling
General description
The NovaSeptum® SURe sterile sampling assembly is for single-use manufacturing processes, where aseptic connection and disconnection is necessary.
The product comes as a single unit with a High Purity bag. 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.
The product comes as a single unit with a High Purity bag. 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
Sterility testing, bioburden, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, fermentation applications or any other routine lab testing
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
40 units per box
Preparation Note
Assembled under ISO Clean Room Class 8 conditions in a facility certified to ISO 14644-1 standards.
Analysis Note
Components in contact with sampling fluid are
composed of materials which meet the criteria for
Biological Reactivity Testing.
These tests can be any one or a combination of the following test methods: USP <88> Class VI (in vivo), USP <87> (in vitro), ISO 10993-5 (in vitro).
composed of materials which meet the criteria for
Biological Reactivity Testing.
These tests can be any one or a combination of the following test methods: USP <88> Class VI (in vivo), USP <87> (in vitro), ISO 10993-5 (in vitro).
Other Notes
Not autoclavable
Legal Information
AseptiQuik is a registered trademark of Colder Products Company
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
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