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AC711-10250

NovaSeptum® SURe Sampling Unit; High Purity Application

Single; 250mL; AseptiQuik® S connector

Synonym(s):

HP bag, PureFlex™ bag

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Quality Level

400

material

Luer lock (Polycarbonate and Polyisoprene), TPE tubing, polycarbonate connector, polyethylene container ( PureFlex™ film)

sterility

sterile; γ-irradiated

product line

NovaSeptum®

storage condition

room temperature

parameter

max. pressure at 0.50 bar (7.25 psi), 4-40 °C (39-104 °F) (Storage Temperature: –80 (when used with a NovaSeptum®
Case) to 50 °C (–112 to 122 °F))

fitting

inlet connection (AseptiQuik® S and TPE tubing), outlet connection (3-piece Luer-Lok®, 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 high purity bag 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, 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
  • Ideal for autoclavable application
  • Can connect to any sampling device with an AseptiQuik(R): bags, bottles, syringes, and conical tubes
  • Stocked and ready-to-ship for fast delivery

Packaging

21 units per box

Preparation Note

Assembled under ISO Clean Room Class 8 according to ISO 14644-1 standards.

Analysis Note

All component materials, in contact with sampling liquid, meet the criteria for Biological Reactivity Testing.These tests can be any one or a combination of the following test methods USP <88> ; Systemic Injection Test (In Vivo), USP <87> Cytotoxicity Elution Test (In Vitro), ISO 10993-5.

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
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany

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Regulatory Information

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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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