Skip to Content
Merck

Key Documents

View All Documentation

E714-10100

NovaSeptum® GO Sampling System; High Purity Application

5x100mL

Sign In to View Organizational & Contract Pricing.

Select a Size

Change View

About This Item

UNSPSC Code:
41104105
Technical Service
Need help? Our team of experienced scientists is here for you.
Let Us Assist

Quality Segment

400

material

316 stainless steel cannula (ASTM®), PureFlex™ polyethylene bag, TPE tubing (Thermoplastic elastomer), polyester body, silicone septum (platinum-cured)

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; β-irradiated

product line

NovaSeptum® GO

feature

autoclavable: no

parameter

-20-50 °C temp. range (-4-122 °F) (up to -80°C/-112°F when used with a NovaSeptum® Case), 0.30 bar max. pressure (4.35 psi)

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

fitting

female Luer-Lok® outlet (3-piece), male Luer-Lok® outlet (3-piece containing an injection site), male Luer-Lok® outlet (3-piece)

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

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. NovaSeptum® GO high purity bags for multi-sampling systems are available from 50 to 250 mL.
Device configuration: Multi-sampling

Application

Regular Sampling Sample (with or without protective case).
Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications.

Packaging

5x100 ml bags, 5 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 (bag): Polyethylene film (PureFlex™ film)
  • Tubing: Thermoplastic elastomer (TPE)
  • Outlet Tubing: 3-piece Luer-Lok®, containing a male, female and an injection site

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
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany

Still not finding the right product?

Explore all of our products under NovaSeptum® GO Sampling System; High Purity Application

Stay compliant with GMP using the Emprove® Program

Accelerate qualification, maintain compliance, and save time with Emprove® Dossiers.

Download Dossiers

Note: you will be brought to EmproveSuite.com. Your username and password are separate from SigmaAldrich.com and may differ.

Register for free and access Emprove® Dossiers within minutes. Upgrade your subscription plan to unlock advanced and customized content in the Emprove® Suite

Not finding what you are looking for? Visit the Emprove® Program Help page.

Already Own This Product?

Find documentation for the products that you have recently purchased in the Document Library.

Visit the Document Library