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重要文件

E5SU871

Millipore

NovaSeptum® GO Preloaded System with Bottle, 5-port

sterile; γ-irradiated

同義詞:

NovaSeptum® GO Bottle, Sterile_Sampling_Container

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About This Item

分類程式碼代碼:
41104105

材料

316 stainless steel cannula (ASTM®)
PETG bottle
TPE tubing
polyester body (platinum-cured)
polyethylene bottle
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; γ-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)

雜質

<2.15 EU/device bacterial endotoxins (LAL test)

接頭

outlet tubing (cap)

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
The NovaSeptum® GO bottle sampling unit is intended for applications where high purity, such as low endotoxin levels, is required. This sampling unit is available with a 2 mm needle and must be used with a NovaSeptum® GO holder. The bio-neutral plastic bottles are ideal for all tests and available in a range of sizes. 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.

應用

sterile sampling

包裝

E5SU871-80060 (5x60 ml bottles, 6 units per box)
E5SU871-80125 (5x125 ml bottles, 4 units per box)
E5SU871-80250 (5x250 ml bottles, 3 units per box)
E5SU871-80500 (5x500 ml bottles, 2 units per box)

成分

  • Septum: Platinum-cured silicone
  • Body: Polyester
  • Cannula: ASTM® 316 L Stainless steel
  • Fluid contact layer (bottle): Polyethylene Terephtalate Glycol
  • Tubing: Thermoplastic elastomer (TPE)
  • Outlet Tubing: Cap

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
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany

分析證明 (COA)

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