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Merck
CN

E464-90005

NovaSeptum® GO Sampling Unit; Accurate Volume Application

Manifold; 5x5mL

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UNSPSC Code:
41104105

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material

316 stainless steel cannula, PureFlex™ polyethylene bag (Drainage bag), 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 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), 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.

room temp

Quality Level

400

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General description

Device configuration: multiple sampling
The NovaSeptum® GO Accurate volume syringes are used in critical sampling operation in Biopharma environment where high value drugs are manufactured and where material waste downsizing is at utmost importance.
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. 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, sterile sampling, and fermentation applications

Packaging

5 x 5 ml syringes, 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
Drainage bag: Polyethylene film (PureFlex™ film)
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
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany

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