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Merck
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缓冲液过滤

缓冲液处理囊式和筒式滤器

生物生产下游工艺步骤需要大量缓冲液,其中的滤器选择高度依赖特定工艺步骤自身的需求。针对非关键步骤,我们提供可降低生物负荷的滤器,以实现卓越的工艺经济性;而我们的无菌级缓冲液滤器则可提供更高的流速和通量,从而实现卓越的工艺效率。 

我们齐全的滤器可实现从实验室工艺开发工具,到中式和生产规模的无缝扩展,主流产品形式为一次性、伽马射线辐照囊式和筒式。此外,每一款滤器都提供了多种连接选项,可针对您的特定工艺需求灵活选择。

  • Millipore Express® SHC(无菌级,高容量)滤器含有两层(0.5/0.2 µm)的聚醚砜(PES)膜,同时具有无菌级的性能、广泛的化学相容性和出色的截流能力。每款滤器的制造过程均经过完整性测试。
  • 0.22 µm  Durapore®滤器含有一层0.22 µm聚偏二氟乙烯(PVDF)膜,同时具有低吸附性、低浸出性,无纤维。每款滤器的制造过程均经过完整性测试。


相关资源

  • Tech Note: Bioburden Reduction and Particulate Retention Using Milligard® PES Filters

    Milligard® PES filters with two layers of asymmetric polyethersulfone (PES) membranes are widely used in biopharmaceutical production to safeguard process fluids from contaminants. They can be used as prefilters to increase the capacity of sterilizing filters or independently to reduce bioburden and turbidity in process streams, providing an alternative to sterilizing-grade filters for bioburden risk reduction in non-critical process steps.

  • Tech Note: Holistic Buffer Preparation

    Buffer preparation is critical in biologics production, requiring significant volume and precise timing. The document will discuss optimizing in-house preparation and potential outsourcing, considering various options based on process needs.

  • Tech Note: Recommendations for Steam-in-place Sterilization of Filtration Trains Containing Milligard® PES Prefilters

    Milligard® PES filters reduce bioburden and protect downstream filters in biotechnology manufacturing. They can be sterilized by SIP, autoclave, and gamma irradiation, but require wetting before use. Studies are ongoing to establish best practices for SIP sterilization when using these filters in a filtration train.

  • Tech Note: Integrity Test Troubleshooting - Beyond Rewet and Retest

    Integrity testing is crucial for sterilizing grade filters in biopharmaceutical processing. This application note aims to ensure accurate integrity testing and address specific challenges.

  • Guide: Durapore® Family Guide

    Durapore® polyvinylidene fluoride (PVDF) membranes, known for their reliability, are offered in multiple pore sizes and formats to meet diverse bioprocessing needs such as liquid sterile filtration, in-line integrity testing, and final sterilizing filtration. These low protein binding and non-fiber releasing filters are widely applicable, including in cell culture media filtration, monoclonal antibodies, vaccines, and ophthalmic and parenteral production, with all Durapore® sterilizing filters undergoing 100% integrity testing during manufacturing.

  • Guide: Millipore Express® Family Guide
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质量标准和档案

为和我们的产品线互为补充,Emprove®计划提供了三种类型的档案,可针对开发和制造运行各环节提供支持,包括认证、风险评估和工艺优化环节。这些档案整合了全面的产品专用测试数据、质量声明和监管信息,可方便获取。





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