Quality Level
material
connector (Polyester, 316 stainless steel cannula (ASTM®) and Platinum-cured silicone trigger
Polycarbonate), silicon tubing
sterility
sterile; γ-irradiated
product line
NovaSeptum®
storage condition
room temperature
parameter
max. pressure at 0.50 bar (7.25 psi), 4-40 °C operating temperature (39-104 °F)
fitting
inlet connection (1mm trigger and silicone tubing), inlet connection (AseptiQuik® S High Temperature)
application(s)
sterile sampling
General description
The NovaSeptum® SURe transfer unit is ideal for manufacturing processes requiring autoclave. This product comes as a single unit with a NovaSeptum® 1mm trigger and connects via a High Temperature AseptiQuik® S connector to any other sampling assemblies with AseptiQuik® S connector. The design enable to autoclave your equipment with the transfer unit and then connect any sampling design with an AseptiQuik® S connection to take your samples. 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, 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
- Ideal for autoclavable application
- Can connect to any sampling device with an AseptiQuik(R): 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 according to ISO 14644-1 standards.
Analysis Note
All component materials, in contact with sampling liquid, meet the criteria for Biological Reactivity Testing.These tests can be any one or a combination of the following test methods USP <88> ; Systemic Injection Test (In Vivo), USP <87> Cytotoxicity Elution Test (In Vitro), ISO 10993-5.
Other Notes
Autoclavable (up to 1h, 125°C)
Legal Information
ASTM is a registered trademark of American Society for Testing and Materials
AseptiQuik is a registered trademark of Colder Products Company
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
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Regulatory Information
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