5443

NovaSeptum^® SURe Accurate Volume Syringe Sampling Unit

Manifold (3-valve) with Inlet C-Flex^® Tubing, sterile; γ-irradiated, volume 5 mL & 20 mL

• UNSPSC Code: 41104019

Propiedades

• Quality Level: 400
• material: C-Flex tubing, polycarbonate Luer lock, polycarbonate body, polycarbonate cannula, polycarbonate clip, polycarbonate container, silicone tubing
• sterility: sterile; γ-irradiated
• product line: NovaSeptum^® SURe
• storage condition: room temperature
• parameter: -80-50 °C temp. range (-112-122 °F), 0.5 bar max. pressure (7.25 psi)
• 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

Descripción

General description

The NovaSeptum^® SURe sterile sampling assembly is for single-use manufacturing processes, where aseptic connection and disconnection is necessary.
This product comes as a manifolded unit with accurate volume syringes and connects via C-flex^® tubing for thermowelding. The syringes enable sampling for small, accurate volumes, which is particularly important for sampling of high value products. 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

8 units per box (3*5mL)
6 units per box (3*20mL)

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).

Other Notes

Not autoclavable

Legal Information

C-Flex is a registered trademark of Saint-Gobain Performance Plastics Corp.

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany