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Merck
CN

5741

NovaSeptum® SURe High Purity Bag Sampling Unit

with Inlet C-Flex® Tubing, sterile; γ-irradiated, volume 100 mL

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About This Item

UNSPSC Code:
41104019
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Quality Level

material

C-Flex tubing, TPE tubing, polycarbonate Luer lock, polycarbonate container, polyethylene body, polyethylene cannula, polyethylene clip

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

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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 single unit with a high purity bag and connects via C-flex® tubing for thermowelding. 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

50 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).

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

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Articles

Explore microbial control strategies in drug manufacturing: bioburden management, contamination prevention, and reliable closed sampling.

Explore the importance of closed sampling in pharma manufacturing, focusing on regulatory guidance, bioburden control, and process monitoring.

Symbolic depiction of a (bio-)pharmaceutical process with persons in lab coats working, possibly taking samples.

Struggling to find a sampling solution for your process? Explore sterile manual and automated aseptic sampling to ensure product quality and safety.

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Global Trade Item Number

SKUGTIN
5741-1010004065270784391

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