属性

质量水平

400

物料

Nylon 66 adapter (for needle)
PVC tubing (double lumen)
mixed cellulose esters (MCE) membrane
plain filter
stainless steel (for needle)
styrene-acrylonitrile (SAN) (for canister)

Agency

EP (2.6.1)
JP (4.06)
USP 71

无菌性

sterile; γ-irradiated

manufacturer/tradename

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)
3.1 bar max. inlet pressure (45 psi) at 25 °C
45 °C max. temp.

tubing L

850mm

颜色

blue Canister Base

基质

MF-Millipore

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说明

一般描述

设备配置：2个罐

SteritestNEO设备是一种膜过滤设备，用于可过滤药品的无菌测试。该设备简化了从处理到可追溯性的测试的各个方面。封闭式系统最大程度地减少了假阳性，并提供了最高水平的质量和可靠性。该设备确保测试过程中药品不会暴露于环境中。该测试系统与SteritestSymbio泵、专用附件以及高品质培养基和冲洗液一起使用时，可提供优化的、完全合规的测试过程。该设备包括一个便于接触安瓿的单针和一个单独的排气针。单个针头适配器可轻松进入可折叠袋。蓝色底部罐表示混合纤维素酯（MCE）膜，该膜为标准产品提供了最佳的过滤流速。

应用

SteritestNEO设备用于对大体积的注射药物和不含抗生素活性的合成药物进行无菌测试。

特点和优势

One-stop-shop for sterility testing with our devices, pumps, media, fluids, and services

Steritestdevices 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 SteritestNEO 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 SteritestNEO 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 SteritestNEO device before release from manufacturing

包装

Pack of 10 single packed blisters per box

法律信息

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

STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany

Millipore TZHALA210 Millipore TZHALA210 集菌培养器