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ACC71

NovaSeptum® SURe Conical Tube Sampling Unit

with AseptiQuik® S connector, sterile; γ-irradiated, volume 15 mL

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UNSPSC Code:
41104019
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Quality Segment

400

material

TPE tubing, polycarbonate connector, polystyrene body, polystyrene cannula, polystyrene clip, polystyrene container

sterility

sterile; γ-irradiated

product line

NovaSeptum® SURe

storage condition

room temperature

parameter

0.5 bar max. pressure (7.25 psi), 4-40 °C temp. range (39-104 °F)

fitting

inlet connection (TPE), Luer-Lok® outlet connection (3-piece), outlet connection (containing a male, female and an injection site)

application(s)

sterile sampling

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 conical tube and connects via AseptiQuik® S connector. 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

35 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

AseptiQuik is a registered trademark of Colder Products Company
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany

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資料

Regulatory Framework for Sampling in Drug Manufacturing

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

Bioprocess Sampling Systems: Find the Right Sampling Approach for Your Needs

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

Improve Product Quality and Process Control with Sampling Solutions for Pharma and Biopharma

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

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関連コンテンツ

Data Sheet -NovaSeptum® SURe

NovaSeptum® SURe SterileSampling AssembliesStandard, closed, and sterile sampling assemblies foryour single-use manufacturing processes

Virus Inactivation

Learn more on mAb downstream processing, more specifically virus inactivation and the relevant associated products.

グローバルトレードアイテム番号

カタログ番号GTIN
ACC71-8001504065270784414