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Merck
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重要文件

TZVC00010

Millipore

Steridilutor® NEO 装置

For liquids and soluble powders in vials., Devices with an expansion chamber for sample preparation and dilution., pkg of 10 blisters per box, Single packed

同義詞:

用于无菌测试的Steridilutor® NEO设备

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About This Item

分類程式碼代碼:
23151818
eCl@ss:
32014001
NACRES:
NB.24

材料

Nylon 66 adapter (for needle)
PVC tubing
stainless steel (for needle)

品質等級

400

agency

EP (2.6.1)
JP (4.06)
USP 71

無菌

sterile; γ-irradiated

特點

Devices with an expansion chamber for sample preparation and dilution.

製造商／商標名

Steridilutor®

包裝

pkg of 10 blisters per box, Single packed

輸入

sample type pharmaceutical(s)

應用

pharmaceutical
sterility testing

相容性

For liquids and soluble powders in vials.
for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01)
for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01)
for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01)

運輸包裝

ambient

相關類別

一般說明

带扩展室的 Steridilutor® NEO 装置是管和针头组件，用于难溶粉末、稀释超强抗生素和小瓶中库产品。纯产品（固体或液体）难以冲洗，产品中的残留物可能是无菌测试中的主要抑制因素。对于粉末，需要进行充分溶解，避免任何可能的聚集。强烈建议对液体抗生素进行稀释，降低抗菌剂的浓度。这样处理能降低试剂与过滤器结合的可能性。扩展室用于小瓶中排出残留的真空或压力，不存在无滴落或污染风险。小直径双针头将测试产品与稀释剂连接起来。随后将稀释的产品用合适的 Steritest® NEO 装置过滤。

應用

带扩展室的Steridilutor® NEO 装置用于稀释粉末和超强抗生素以及小瓶中的库产品。扩展室可排空稀释容器。

法律資訊

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

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配置

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需要但未提供

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分析證明 (COA)

輸入產品批次/批號來搜索 分析證明 (COA)。在產品’s標籤上找到批次和批號，寫有 ‘Lot’或‘Batch’.。

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文章

Application Note - Sterility Testing of Products with Antimicrobial Properties

Steritest™ NEO System – Specific Steritest™ NEO closed systems allow aseptic dissolution/dilution of product samples. The Steridilutor® NEO system is specifically designed to dissolve and dilute drugs in vials. The Steridilutor® NEO device for liquid transfer kit enables to dilute liquids from open ampoules into a diluent container with septum.

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