5743

NovaSeptum^® SURe High Purity Bag Sampling Unit

Manifold (3-valve) with Inlet C-Flex^® Tubing, sterile; γ-irradiated, volume 100 mL

• UNSPSC Code: 41104019

Properties

• material: C-Flex tubing; TPE tubing; polycarbonate Luer lock (; ); polyethylene body; polyethylene container
• Quality Level: 400
• sterility: sterile; γ-irradiated
• product line: NovaSeptum^® SURe
• storage condition: room temperature
• parameter: -80-50 °C temp. range (112-122 °F) (when used with a NovaSeptum^® Case); 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

Description

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 manifolded unit with 3 High Purity bags. 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

12 units per box (3*100mL)

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