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E714-10250

NovaSeptum® GO Sampling Unit; High Purity Application

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Manifold; 5x250mL

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About This Item

UNSPSC代码:
41104105

物料

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

质量水平

400

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)

无菌性

sterile; β-irradiated

产品线

NovaSeptum® GO

特点

autoclavable: no

参数

-20-50 °C temp. range (-4-122 °F) (up to -80°C/-112°F when used with a NovaSeptum® Case)
0.30 bar max. pressure (4.35 psi)

杂质

<2.15 EU/device bacterial endotoxins (LAL test)

配件

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

应用

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

储存温度

room temp

相关类别

一般描述

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. NovaSeptum® GO high purity bags for multi-sampling systems are available from 50 to 250 mL.
Device configuration: Multi-sampling

应用

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

包装

5x250 ml bags, 5 units per box

组分

  • 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

制备说明

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.

法律信息

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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