Merck
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E464

Millipore

NovaSeptum® GO Accurate Volume Syringe Sampling System, Manifold (5-valve)

sterile; β-irradiated

Synonym(s):
NovaSeptum GO Accurate Volume Syringes

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

according to ISO 11137 (sterilization)
according to ISO 146441
meets USP 88 biological reactivity (all component materials)

无菌性

sterile; β-irradiated

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

application(s)

pathogen testing
pathogen testing
pyrogen testing
sterility testing

储存温度

room temp

Related Categories

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

E464-90005 (5 x 5 ml syringes, 5 units per box)
E464-90020 (5 x 20 ml syringes, 5 units per box)

组分

  • 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®

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 Millipore AB - Sweden
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany

Certificate of Analysis

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Certificate of Quality

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