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E461-90005

NovaSeptum® GO Sampling System; Accurate Volume Application

5mL

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UNSPSC Code:
41104105
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Quality Segment

400

material

316 stainless steel cannula, polycarbonate syringe (fluid contact layer), polyester body, silicone septum (platinum-cured), silicone syringe (medical fluid contact layer; platinum cured silicone), silicone tubing

agency

ISO 10993-5 (all components materials), USP 87 Cytotoxicity Elution Test (In Vitro) , according to ISO 11131 (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; β-irradiated

product line

NovaSeptum® GO

feature

autoclavable

parameter

-80-134 °C temp. range (-112-273 °F), 0.50 bar max. pressure (7.25 psi)

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

fitting

female Luer-Lok® outlet, male Luer-Lok® outlet

application(s)

cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pathogen testing
pharma/biopharma processes
pyrogen testing
sterile sampling
sterility testing
viral therapy

storage temp.

10-30°C

General description

Device configuration: single unit sampling
NovaSeptum® GO Accurate Volume Syringes are designed to take samples from 1 mL to 20 mL, enabling operators to directly dispense sample products with milliliter accuracy. The ability to accurately measure the sample taken is particularly important for sampling of high value products and reduces expensive product waste. For sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis and fermentation applications. The syringes are ideal for storage. A closed, sterile sampling method can significantly reduce risk of cross contamination. Ideal for sampling from aseptic and sterile processes, the NovaSeptum® GO sterile sampling system provides consistently representative samples, safely and securely.

Application

Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications

Packaging

50 units per box

Preparation Note

Units are integrity tested at regular intervals during manufacturing.

Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.

Other Notes

  • Septum: Platinum-cured silicone
  • Body: Polyester
  • Cannula: ASTM® 316 L Stainless steel
  • Fluid contact layer (syringe): Polycarbonate, platinum-cured silicone, medical silicone fluid
  • Tubing: Silicone
  • Outlet Tubing: Female and male Luer-Lok®

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
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

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.

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.

Automated Sampling and Process Monitoring for Biopharma

Discover how Process Analytical Technology (PAT) enhances biopharmaceutical manufacturing through aseptic sampling and real-time quality assurance.

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グローバルトレードアイテム番号

カタログ番号GTIN
E461-9000504054839988462