细胞培养基滤器

无菌过滤用于保护上游细胞培养操作免受污染。无论您需要降低细菌还是支原体污染的风险,我们的Millipore Express®非全氟烷基物质(non-PFAS)细胞培养基滤膜都能提供微生物去除方案,同时确保最佳细胞生长与生产效率,并满足工艺经济性所需的过滤容量与吞吐量性能。
在选择滤器前,建议您进行风险分析以确定所需的生物负荷控制级别——需选用灭菌滤器或兼具支原体去除功能的灭菌滤器。每款滤器均能提供无菌保障,让您对过滤过程充满信心。此外,我们的过滤产品线由Emprove®计划提供支持,该计划可提供所需文件以简化风险评估流程并优化合规管理。
如需协助确定适合您工艺的滤芯,请联系我们。
灭菌细胞培养基滤器
Millipore Express® SHC(无菌、高容量)滤器为细胞培养基灌注提供极高的过滤容量。其集成式0.5微米聚醚砜(PES)预滤膜可保护0.2微米PES灭菌膜,最大化过滤容量并提升过滤稳定性。
- 密理博Express® SHC滤器具有高通透性,易润湿且便于完整性测试,并具备广泛的化学兼容性。
- 大面积胶囊和筒式滤芯设计在不增加占地面积的前提下,最大限度地提高了过滤效率。
细胞培养基用支原体去除滤器
Millipore Express® SHR滤器(无菌、高截留)可实现≥7.0对数级支原体去除,并为需要额外安全保障的上游工艺提供灭菌级性能。0.1微米支原体截留PES膜兼具高通透性与卓越微生物截留能力。
针对易堵塞的细胞培养基,我们的Millipore Express® SHRP滤器内置0.5微米PES预滤器,可保护0.1微米支原体截留膜,从而提升滤器容量并增强工艺稳定性。
从实验台到生产规模的多种规格
我们的细胞培养基过滤器提供:
- OptiScale®规格实现高效筛选与规模化生产,卡式与胶囊规格在制造过程中均通过100%完整性测试。
- 大面积胶囊与滤芯规格,在不增加占地面积的前提下最大化过滤效率。
- 可高压灭菌、预灭菌或伽马射线灭菌的规格,可集成至Mobius®一次性组件。
胶囊式与筒式滤器的近似过滤面积。完整信息及各产品线精确过滤面积请参阅产品规格说明。更多滤器规格详情请参阅我们的技术文章。
产品
Products
质量标准与文件记录
所有Millipore Express®滤膜均依据经认证注册机构批准的ISO 9001质量管理体系进行设计、开发和制造,并附有质量证书。
所有Millipore Express® SHC、Millipore Express® SHR及Millipore Express® SHRP滤膜均纳入Emprove®计划体系,该计划提供三类技术档案以支持开发与生产各阶段需求,涵盖资质认证、风险评估及工艺优化等环节。这些档案以便捷形式整合全面的产品专属测试数据、质量声明及法规信息,助您从容推进项目进程。
相关资源
- Article: Millipore Express® Express Sterilizing-Grade Membrane Filters Selection Guide
Discover various Millipore Express® sterilizing-grade membrane filters for liquid filtration in aseptic drug production.
- Article: Optimizing Upstream Processing: Media Filtration and Cell Culture Performance
This technical article provides guidance on selecting and sizing filters for cell culture media filtration.
- Application Note: Cell Culture Media Filtration. Selection and Sizing Filters for CHO Cell Culture Processes
Explore throughput performance of Millipore Express® aseptic filters for cell culture media filtration and their impact on filter sizing.
- Application Note: Cell Culture Media Filtration. Evaluating Performance of CHO Cell Cultures
Learn how to check if your media filter impacts performance. Studies confirmed PES and PVDF membrane filters did not affect cell growth and viability.
- Technical Note: Performance of High-Area Millipore Express® Cartridge Filters
High area filters can improve filtration productivity for mid- to high- plugging streams. Read how our model can help predict the benefits for different streams.
- Technical Note: Mycoplasma clearance by Millipore Express® SHR filters at pilot and production scales
Retention studies demonstrate that both pilot and production-scale filters consistently provided the expected level of mycoplasma retention over extended filtration times, affirming their performance under continuous flow processing conditions.
- Application Note: Cell Culture Media Mixing and Microfiltration: Reducing Risk with Single-use Technology
This application note explains considerations for the preparation of cell culture media and focuses on the benefits of mixing and filtration using single use technologies.
- Millipore Express® Family Guide
Read this guide to review key differentiators and product specifications of Millipore Express® membrane filters.
- Technical Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
Filter integrity testing doesn’t always go smoothly. Learn how to avoid costly mistakes and troubleshoot integrity test challenges.
- Brochure: Vmax™ Constant Pressure Test for sizing Aseptic Filters
This protocol describes how to use results from small scale studies to predict filtration area requirements.
- Article: Prefilters and Sterilizing-grade Filter Formats: Selection Guide
Aseptic filters are offered in disposable capsules and cartridge formats. This guide will help you find the right format for your bioburden control.
相关网络研讨会
选择生物制造用无菌过滤器需根据具体工艺需求而定。了解如何为您的工艺选择最佳过滤器。
变更管理常被视为复杂的任务。了解如何运用基于风险的方法来加速产品获批后的变更流程。
本次网络研讨会阐述了未受控生物负荷的影响、生物负荷来源以及降低风险的策略。通过最小化风险,可减少故障发生和调查需求。
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