屬性

質(zhì)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

無(wú)菌性

sterile; γ-irradiated

manufacturer/tradename

Steritest

包裝

pkg of 10 blisters per box, Single packed

參數(shù)

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

顏色

blue Canister Base

基質(zhì)

MF-Millipore

展開

說(shuō)明

一般描述

設(shè)備配置：2個(gè)罐

SteritestNEO設(shè)備是一種膜過(guò)濾設(shè)備，用于可過(guò)濾藥品的無(wú)菌測(cè)試。該設(shè)備簡(jiǎn)化了從處理到可追溯性的測(cè)試的各個(gè)方面。封閉式系統(tǒng)最大程度地減少了假陽(yáng)性，并提供了最高水平的質(zhì)量和可靠性。該設(shè)備確保測(cè)試過(guò)程中藥品不會(huì)暴露于環(huán)境中。該測(cè)試系統(tǒng)與SteritestSymbio泵、專用附件以及高品質(zhì)培養(yǎng)基和沖洗液一起使用時(shí)，可提供優(yōu)化的、完全合規(guī)的測(cè)試過(guò)程。該設(shè)備包括一個(gè)便于接觸安瓿的單針和一個(gè)單獨(dú)的排氣針。單個(gè)針頭適配器可輕松進(jìn)入可折疊袋。藍(lán)色底部罐表示混合纖維素酯（MCE）膜，該膜為標(biāo)準(zhǔn)產(chǎn)品提供了最佳的過(guò)濾流速。

應(yīng)用

SteritestNEO設(shè)備用于對(duì)大體積的注射藥物和不含抗生素活性的合成藥物進(jìn)行無(wú)菌測(cè)試。

特點(diǎn)和優(yōu)勢(shì)

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

包裝

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

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