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Nanodrug production system/GMP/MPE-P3 MICROFLUIDIC PREPARATION EQUIPMENT

Category:Preparation Equipment > Other Preparation Equipment
Product Name:Nanodrug production system/GMP/MPE-P3 MICROFLUIDIC PREPARATION EQUIPMENT
Price(USD):Negotiable
Company:Suzhou Aitesen Pharmaceutical Equipment Co., Ltd.

Basic Info
  • Factory Location: Suzhou, Jiangsu province

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

  • Sample Provided: no

    Payment Terms: other

    MICROFLUIDIC PREPARATION EQUIPMENT

    簡(jiǎn)介

    ITESEN Micro流體制備系統(tǒng)定位于微納復(fù)合物注射劑的科學(xué)研究和應(yīng)用。通過專利微流控芯片、高度集成和系統(tǒng)的硬件系統(tǒng)(如輸送泵系統(tǒng)、PAT工具包等),以及以工藝應(yīng)用為導(dǎo)向的人性化軟件系統(tǒng),為脂質(zhì)體、LNP、微乳液、微晶、微球等不同藥物遞送載體的科研和產(chǎn)業(yè)化應(yīng)用提供成熟、多樣化的解決方案?;贏ITESEN微流控技術(shù)的設(shè)備和解決方案已應(yīng)用于多種臨床和上市藥物的研究和產(chǎn)業(yè)化。

     

    MPE-P3 MICROFLUIDIC PREPARATION EQUIPMENT

    MPE-P3 MICROFLUIDIC PREPARATION EQUIPMENT

    MPE-P3 is a production type of Microfluidic Preparation System widely used in approved clinical mRNA vaccine projects, pre-IND nucleic acid drug projects, and FDA approved IND applications.

    MPE-P3 is designed and manufactured in accordance with GMP requirements, providing a complete set of GMP validation documents. The operating system software has rich functions and can be used for continuous preparation and online dilution of LNP samples, as well as for GMP production of samples for different projects and processes. The PLC control system is quipped with a formula program that allows for flexible formulation of sample production strategies. Equipped with audit tracking function, in compliance with FDA 21 CFR part 11 requirements.

    MPE-P3 supports customization, which can be customized according to different requirements such as process parameters, upstream and downstream linkage strategies, site constraints etc.

     

    Model

    MPE-P3

    Minimum Sample Volume

    100mL

    Maximum Pressure

    10MPa

    Flow Rate Rito

    Can be set, system is not limited

    Online DilutionRatio

    Can be set, system is not limited

    Preparation Flow Rate

    ≥400mL/min

    Diluent Flow Rate

    ≥1000mL/min

    Automatic Disposal


    Yes

    Chip Material

    Metal,SS316L material

    Operation Mode

    PLC control system

    Platform Expansion

    Both preparation chip and dilution chip can use the same structure as the pilot equipment.

    Audit Trail

    Compliance with FDA 21 CFR part 11

    Recipe Procedures

    Support

    CIP

    Support

    Others

    Supports customization, including but not limited to: pump flow rate, 3D design, PAT tool type, software system, etc.

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