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Merck
CN
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主要文件

安全信息

DEM461-90005

Millipore

Trial kit - NovaSeptum® GO; Accurate Volume Syringe Sampling System, 5ml

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About This Item

UNSPSC代码:
60104202

物料

polycarbonate syringe (Fluid contact layer)
polyester body
silicone septum (platinum-cured)
silicone syringe (Fluid contact layer, medical silicone fluid)
silicone syringe (Fluid contact layer, platinum-cured)
silicone tubing
stainless steel body (ASTM® 316 L)

质量水平

400

Agency

according to ISO ISO 11137
meets USP 88 Biological Reactivity

无菌性

sterile; β-irradiated

产品线

NovaSeptum® GO

特点

autoclavable: no

参数

-80-121 °C temp. range (-112-250 °F) (20 mL)
-80-134 °C temp. range (-112-273 °F) (5 mL)
0.50 bar max. pressure (7.25 psi)

杂质

<2.15 bacterial endotoxins (LAL test, EU/device)

配件

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

应用

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

储存温度

room temp

一般描述

A range of NovaSeptum® GO small pack size kits available to trial a sterile sampling solution for your process. Choose from several collection container types: high purity bags, autoclavable bags, bottles or accurate volume syringes (5 containers per pack). The 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 Accurate Volume Syringes are designed to take samples from 1 mL to 20 mL, enabling operators to directly dispense sample products with milliliter accuracy. Autoclavable bags are intended for applications where the unit is connected to a vessel that needs to be sterilized by autoclave. Bio-neutral plastic bottles or high purity bags are ideal for all tests and are available in a range of sizes. Use a trial kit in combination with a NovaSeptum® GO holder.

应用

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

包装

5x accurate volume syringe 5ml

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

All component materials, in contact with sampling liquid, meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo.
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.
Assembled under ISO Clean Room Class 8 conditions in a facility certified to ISO 14644-1 standards.

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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