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About This Item

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物料

316 stainless steel cannula
polycarbonate syringe (fluid contact layer)
polyester body
silicone septum (platinum-cured)
silicone syringe (medical fluid contact layer; platinum cured silicone)
silicone tubing

质量水平

400

Agency

ISO 10993-5 (all components materials)
USP 87 Cytotoxicity Elution Test (In Vitro)
according to ISO 11131 (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

参数

-80-134 °C temp. range (-112-273 °F)
0.50 bar max. pressure (7.25 psi)

杂质

<2.15 EU/device bacterial endotoxins (LAL test)

配件

female Luer-Lok® outlet
 male Luer-Lok® outlet

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

Device configuration: single unit sampling
NovaSeptum® GO Accurate Volume Syringes are designed to take samples from 1 mL to 20 mL, enabling operators to directly dispense sample products with milliliter accuracy. The ability to accurately measure the sample taken is particularly important for sampling of high value products and reduces expensive product waste. For sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis and fermentation applications. The syringes are ideal for storage. 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.

应用

Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications

包装

50 units per box

组分

  • Septum: Platinum-cured silicone
  • Body: Polyester
  • Cannula: ASTM® 316 L Stainless steel
  • Fluid contact layer (syringe): Polycarbonate, platinum-cured silicone, medical silicone fluid
  • Tubing: Silicone
  • Outlet Tubing: Female and male Luer-Lok®

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

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