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Merck
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Key Documents

E5SU711

Millipore

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

sterile; β-irradiated

别名:

NovaSeptum® GO High Purity Bag

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About This Item

分類程式碼代碼:
41104105

材料

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

品質等級

agency

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

無菌

sterile; β-irradiated

產品線

NovaSeptum® GO

特點

autoclavable: no

參數

-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)

雜質

<2.15 EU/device bacterial endotoxins (LAL test)

接頭

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

應用

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

儲存溫度

room temp

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一般說明

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.

應用

sterile sampling

包裝

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)

成分

  • 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


準備報告

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.

法律資訊

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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