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Merck
CN

E9SU711

NovaSeptum® GO Preloaded System with High Purity Bag, 9-port

sterile; β-irradiated

别名:

NovaSeptum® GO High Purity Bag, Sterile_Sampling_Container

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UNSPSC Code:
41104105

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material

316 stainless steel cannula, PureFlex™ polyethylene bag (fluid contact layer), TPE tubing, polyester body, silicone septum (platinum-cured)

agency

according to ISO 11137 (sterilization), meets ISO 146441
146441, meets ISO 88 biological reactivity (all component materials)

sterility

sterile; β-irradiated

product line

NovaSeptum® GO

feature

autoclavable: no

parameter

-20-50 °C temp. range (-4-122 °F) (for 1000 mL), -80-50 °C temp. range (-112-122 °F) (for 50 mL to 250 mL), 0.30 bar max. pressure (4.35 psi) at ±25 °C (for 1000 mL), 0.50 bar max. pressure (7.25 psi) at ±25 °C (for up to 250 mL)

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

fitting

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

storage temp.

room temp

Quality Level

400

application(s)

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

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General description

Device configuration: Single Unit Sampling - Pre-loaded system
The NovaSeptum® GO pre-loaded disposable magazine is available with various standard configurations using NovaSeptum® GO high purity bags, autoclavable bags, bottles, transfer tubes or accurate volume (AV) syringe units. Other configurations are available upon request. For an optimal aseptic solution, use the NovaSeptum® GO pre-loaded disposable magazine together with a 1.5" or 2" NovAseptic® connector and NovaSeptum® GO pre-loaded starter kit (5/9 shot stainless steel base). Ideal for sampling from aseptic and sterile processes, the NovaSeptum® GO sterile sampling system provides consistently representative samples, safely and securely.

Application

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

Packaging

E9SU711-10050 (9x50 ml bags, 3 units per box)
E9SU711-10100 (9x100 ml bags, 3 units per box)
E9SU711-10250 (9x250 ml bags, 3 units per box)
E9SU711-11000 (9x1000 ml bags, 3 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

PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany
NOVASEPTIC is a registered trademark of Merck KGaA, Darmstadt, Germany
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
ASTM is a registered trademark of American Society for Testing and Materials
Luer-Lok is a registered trademark of Becton-Dickinson & Co.

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