選擇合適的緩衝濾波器
章節概述
- 滅菌緩衝液 過濾器
- 生物負荷降低緩衝液 過濾器
- 從實驗台到生產規模的格式
- 品質標準與文件記錄
生物製藥生產需為不同製程步驟準備大量多種緩衝液。選擇緩衝液過濾器可能相當複雜：您選用的過濾膜與規格將取決於製程步驟、所需的生物負荷控制等級、緩衝液用量及緩衝液特性。無論您需要用於製程開發的緩衝液過濾器，還是關鍵配方緩衝液的過濾解決方案，我們皆能滿足需求。 我們的MilliporeExpress®與Milligard®聚醚砜（PES）緩衝液過濾器均採用非全氟烷基物質（non-PFAS）材質，在合理成本下提供高流速與大容量過濾性能，並具備符合特定製程需求的細菌截留規格，實現精準的生物負荷控制。此外，為簡化風險評估與合規流程，我們的過濾產品系列皆由Emprove®計畫提供技術支援。
如需協助選定適合您製程的緩衝濾器，歡迎聯繫我們。
滅菌緩衝濾器 | 生物負荷降低緩衝液過濾器 |
|---|---|
Millipore Express®SHF 濾膜
| Milligard®PES濾膜
*PES：聚醚砜 |
Millipore Express®PHF濾膜
|
滅菌緩衝液過濾器
針對無堵塞緩衝液的滅菌過濾，我們推薦使用Millipore Express®SHF（滅菌、高通量）濾器或Millipore Express®PHF（製程保護、高通量）濾器。所有Millipore Express®膠囊式與筒式濾器（）均採用0.2微米PES滅菌膜，具備高透水性、易潤濕性、完整性檢測特性及廣泛化學相容性。
針對易堵塞緩衝液，Millipore Express®SHC（無菌、高容量）濾器為更佳選擇。此類濾器（）內含整合式0.5微米聚醚砜（PES）預濾膜，可保護0.2微米PES滅菌膜，最大化過濾容量。
- 對於需確保無菌性的關鍵製程緩衝液步驟，應選用Millipore Express®SHF與Millipore Express®SHC濾器。
- 對於非關鍵步驟使用的緩衝液（可能無需無菌保證），Millipore Express®PHF 濾器是經濟實惠的無菌緩衝液過濾選擇。
生物負荷降低緩衝過濾器
Milligard® PES 濾膜可用作生物負荷降低緩衝過濾器。此類濾膜具備快速流速、高通量、易潤濕性、完整性測試便利性及廣泛化學相容性，是經濟實惠的緩衝過濾解決方案。
提供兩種孔徑規格，各具不同生物負荷降低性能：
- Milligard®PES 1.2/0.2 微米標稱值：依據 ASTM F838 方法，通常可去除 ≥ 6 log短桿菌
- Milligard®PES 1.2/0.45 微米：依據 ASTM D3863 與 F838 方法學，通常可達到 ≥ 6 log 濕黴菌（Serratia marcescens）去除率
膠囊式與筒式濾芯的近似過濾面積。完整資訊請參閱產品規格。欲瞭解不同濾芯規格的詳細資訊，請閱讀我們的技術文章。
| 格式 | 尺寸 | 過濾面積 (m²) |
|---|---|---|
| Opti Scale®膠囊 | 25 毫米 | 3.5平方公分 |
| 47 毫米 | 17.7平方公分 | |
| Opticap®小型膠囊* | XL 150 | 0.014-0.025 |
| XL/小型量產 300† | 0.028-0.048 | |
| XL 600 | 0.059-0.101 | |
| Opticap®膠囊 | XL 3 | ~0.13-0.16 |
| XL 5 | ~0.23-0.29 | |
| XL 10 | ~0.49-60 | |
| XLT/T-line 10† | ~0.49-60 | |
| XLT/T-line 20† | ~0.98-1.21 | |
| XLT/T-線 30† | ~1.47–1.81 | |
| 每10英吋高面積Opticap®XLT感測器* | ~1.0 | |
| 每支感測器 | 5英吋 | ~0.23-0.29 |
| 10英吋 | ~0.46-0.48 | |
| 每10吋高面積濾芯 | ~1.0 |
產品
相關資源
- 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: Membrane Prefilters Improve Sterilizing Filter Capacity and Process Economics in Bioprocessing
This technical article focuses on capacity performance improvements in sterilizing filters when Milligard® PES prefilters are upstream.
- Brochure: Mission Control: Strategies for Effective Bioburden and Aseptic Control
Read this brochure to learn more about bioburden control, filter selection, and optimization of your filtration process.
- Millipore Express® Family Guide
Filters containing Millipore Express® membranes provide broad chemical compatibility across a wide pH range, are easy to wet and integrity test, and are available in a range of formats to meet the specific needs of different biomanufacturing operations.
- Technical Note: Extended Bacterial Retention Testing of Millipore Express® SHF 0.2 μm Filters in a Continuous Flow System.
This technical note summarizes retention performance of Millipore Express SHF sterilizing filter over long duration, constant flow processing conditions.
- 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.
- Technical Note: Bioburden Reduction and Particulate Retention Using Milligard® PES Filters
Explore Milligard® PES filters’ high flux, high throughput, efficient bioburden reduction performance for efficient filtration of bioprocessing fluid streams.
- 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.
- Application Note: Optimizing Buffer Mixing and Preparation
This study develops optimal process conditions for mixing and filtration of 1x PBS buffer using the single-use Mobius® MIX solution and Millipore Express® filters.
- Application Note: Improved Accuracy of Scaling with OptiScale® 25 Devices
In this application note, the scalability of OptiScale® 25 devices to 10 inch cartridges was evaluated.
- 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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