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E5SU711

NovaSeptum® GO Preloaded System with High Purity Bag, 5-port

sterile; β-irradiated

别名:

NovaSeptum® GO High Purity Bag

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UNSPSC Code:
41104105
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Quality Segment

400

material

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

agency

according to ISO 11137 (sterilization), according to ISO 146441, meets USP 88 Biological Reactivity (all component materials)

sterility

sterile; β-irradiated

product line

NovaSeptum® GO

feature

autoclavable: no

parameter

-80-50 °C temp. range (-112-122 °F), 0.50 bar max. pressure (7.25 psi) (for 1000 mL), 0.50 bar max. pressure (7.25 psi) (up to 250 mL)

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

fitting

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

application(s)

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

storage temp.

room temp

General description

Device configuration: single unit sampling - preloaded system
TheNovaSeptum® 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

sterile sampling

Packaging

E5SU711-10050 (5x50 ml bags, 8 units per box)
E5SU711-10100 (5x100 ml bags, 8 units per box)
E5SU711-10250 (5x250 ml bags, 7 units per box)
E5SU711-11000 (5x1000 ml bags, 6 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.
NOVASEPTIC is a registered trademark of Merck KGaA, Darmstadt, Germany
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany

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全球贸易项目编号

货号GTIN
E5SU711-1100004061841098027
E5SU711-1005004061841097990
E5SU711-1025004061841098010
E5SU711-1010004061841098003