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Merck
CN

E464-90020

NovaSeptum® GO Sampling Unit; Accurate Volume Application

new

Manifold; 5x20mL

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About This Item

UNSPSC代码:
41104105

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物料

316 stainless steel cannula
PureFlex™ polyethylene bag (Drainage bag)
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 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)
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

一般描述

Device configuration: multiple sampling
The NovaSeptum® GO Accurate volume syringes are used in critical sampling operation in Biopharma environment where high value drugs are manufactured and where material waste downsizing is at utmost importance.
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. 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, sterile sampling, and fermentation applications

包装

5 x 20 ml syringes, 5 units per box

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.

其他说明

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

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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