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Merck
CN
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主要文件

MSP010056

Millipore

Steritest® NEO Device

For liquids in large vials with septa., Blue base canister with vented needle adapter, pkg of 10 blisters per box, Single packed

别名:

Blue Base Steritest® NEO device for sterility testing, Sterility testing device, membrane filtration device, membrane filtration canister, closed membrane filtration

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About This Item

UNSPSC代码:
23151818
eCl@ss:
32014001
NACRES:
NB.24

物料

blue base (canister)
mixed cellulose esters (MCE) (for membrane filter)
plain filter
stainless steel (for needle)
styrene-acrylonitrile (SAN) (for canister)

质量水平

400

Agency

EP (2.6.1)
JP (4.06)
USP (71)

无菌性

sterile; γ-irradiated

特点

Blue base canister with vented needle adapter

制造商/商品名称

Steritest®

包装

pkg of 10 blisters per box, Single packed

参数

120 mL sample volume (graduation marks at 25, 50, 75 and 100 mL)

颜色

blue Canister Base

基质

MF-Millipore™

孔径

0.45 μm pore size

输入

pharmaceutical(s)

应用

pharmaceutical
sterility testing

相容性

For liquids in large vials with septa.

运输

ambient

相关类别

一般描述

Device configuration: 2 canisters

Steritest® NEO is a membrane filtration device for sterility testing of filterable pharmaceutical products. The device simplifies every aspect of testing, from handling to traceability. The closed system minimizes false positives and offers the highest levels of quality and reliability. This device ensures that pharmaceutical products are never exposed to the environment during the testing process. This test system offers an optimized and fully regulatory compliant testing process when used with the Steritest® Symbio pump, specific accessories and high-quality culture media and rinsing fluids. A vented needle adapter vents and transfers the test product from large volume containers with a septum to the Steritest® NEO devices. The blue canister base indicates mixed esters of cellulose membrane. This membrane provides an optimal filtration flow rate for standard products.

应用

The Steritest® NEO Device for liquids in vials is used for sterility testing of large volume parenterals and synthetic drugs without antimicrobial activity.

特点和优势

  • One-stop-shop for sterility testing with our devices, pumps, media, fluids, and services
  • Steritest® devices are manufactured in our Center of Excellence in Molsheim, France, with high-quality control standards maintaining the Certificate of Quality for each lot.
  • New needle design
The design of this new needle has been optimized with short needle length, grips, and ridges to offer dexterity and security to the operator while piercing the small container
  • Smarter workflow
The new Steritest® NEO cartridge device benefits from all the improvements such as colored clamps, graduations for accurate volume measurement, optimized identification, and traceability with the new peel-off label
  • Completely closed set up
Pharmaceutical products are never exposed to the environment during the testing process with Steritest® NEO devices. Filtration, rinsing, media addition and incubation are conducted within a closed system.
  • Consistent performance
100% integrity testing, strict physical and microbiological tests performed at every step of the assembly of the Steritest® NEO device before release from manufacturing.
  • New tubing disconnection tool
The Velax® cutting clamps are mounted on all Steritest® NEO devices and allow safe and easy cutting of the tubes.

包装

Pack of 10 single packed blisters per box

法律信息

MF-Millipore is a trademark of Merck KGaA, Darmstadt, Germany
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
VELAX is a registered trademark of Merck KGaA, Darmstadt, Germany

储存分类代码

11 - Combustible Solids

WGK

WGK 2

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