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5844-80060

NovaSeptum® SURe Sampling Unit; Bottle Application

Single; 60mL

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About This Item

UNSPSC Code:
41104105
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Product Name

NovaSeptum® SURe Sampling Unit; Bottle Application, 5x60mL; Inlet C-Flex® Tubing

Quality Segment

400

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 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 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

Sterility testing, bioburden, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, fermentation applications or any other routine lab testing
Supported Liquid Extraction

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

5 units per box (5x60mL)

Preparation Note

Assembled under ISO Clean Room Class 8 conditions in a facility certified to ISO 14644-1 standards.

Analysis Note

All component materials, in contact with sampling liquid, meet the criteria for Class VI testing based on USP 88 Biological Reactivity, in vivo.

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

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
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany

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