选择合适的缓冲滤波器
章节概述
- 灭菌缓冲液 过滤器
- 生物负荷降低缓冲液 过滤器
- 从实验台到生产规模的规格
- 质量标准与文件记录
生物制药生产需要为不同加工步骤准备大量多种缓冲液。选择缓冲液过滤器可能相当复杂：您选择的过滤膜和规格将取决于工艺步骤、所需的生物负荷控制水平、缓冲液体积以及缓冲液特性。无论您需要用于工艺开发的缓冲液过滤器，还是用于关键配方缓冲液的过滤器，我们都能满足需求。 我们的MilliporeExpress®和Milligard®聚醚砜（PES）缓冲液过滤器均不含全氟烷基物质（PFAS），在合理成本下提供高流速与大容量，并配备针对特定工艺需求的细菌截留规格，实现精准的生物负荷控制。此外，为简化风险评估与合规流程，我们的过滤产品线均纳入Emprove®计划支持体系。
如需协助确定适合您工艺的缓冲液过滤器，请联系我们。
灭菌缓冲液过滤器
对于非堵塞性缓冲液的无菌过滤，我们推荐使用Millipore Express®SHF（无菌、高通量）滤器或Millipore Express®PHF（工艺保护、高通量）滤器。所有Millipore Express®胶囊式和筒式滤器均采用0.2微米PES灭菌膜，具备高通透性、易润湿性、易于完整性测试及广泛的化学兼容性。
对于易堵塞缓冲液，Millipore Express®SHC（无菌、高容量）滤器更为适用。该系列滤器（）内置0.5微米聚醚砜（PES）预滤膜，可保护0.2微米PES灭菌膜，最大限度提升过滤容量。
- Millipore Express®SHF与SHC滤膜适用于需确保无菌性的关键工艺缓冲步骤。
- 对于非关键步骤使用的缓冲液（可能无需无菌保障），Millipore Express®PHF滤器是经济高效的无菌过滤方案。
生物负荷降低缓冲过滤器
Milligard® PES 滤膜可作为生物负荷降低缓冲过滤器使用。该滤膜具有流速快、通量高、易润湿、易于完整性测试及广谱化学兼容性等特点，是经济高效的缓冲过滤解决方案。
提供两种孔径规格，各具不同生物负荷降低性能：
- Milligard®PES 1.2/0.2微米标称孔径：依据ASTM F838方法，对微小短杆菌的去除率通常≥6个对数级
- Milligard®PES 1.2/0.45微米：依据ASTM D3863和F838方法，对枯草芽孢杆菌的去除率通常≥6个对数级
胶囊式和筒式过滤器的近似过滤面积。完整信息请参阅产品规格说明。有关不同过滤器格式的更多信息，请阅读我们的技术文章。
Products
相关资源
- Article: Millipore Express® Express Sterilizing-Grade Membrane Filters Selection Guide
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- Article: Membrane Prefilters Improve Sterilizing Filter Capacity and Process Economics in Bioprocessing
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- Brochure: Mission Control: Strategies for Effective Bioburden and Aseptic Control
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- Millipore Express® Family Guide
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- Technical Note: Extended Bacterial Retention Testing of Millipore Express® SHF 0.2 μm Filters in a Continuous Flow System.
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- Technical Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
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- Technical Note: Bioburden Reduction and Particulate Retention Using Milligard® PES Filters
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- Article: Prefilters and Sterilizing-grade Filter Formats: Selection Guide
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- Application Note: Optimizing Buffer Mixing and Preparation
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- Application Note: Improved Accuracy of Scaling with OptiScale® 25 Devices
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- Article: Membrane Filtration: Efficient Particle Retention and Bioburden Reduction in Bioprocessing Fluid Streams
Some prefilters reduce bioburden and can be used as a cost-effective alternative to sterilizing filters for bioburden control in bioprocessing.
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