選擇正確的緩衝過濾器
生物製藥生產需要大量的多種緩衝液，用於不同的製程步驟。選擇緩衝過濾器可能很複雜：您所選擇的過濾膜和格式取決於您的加工步驟、所需的生物負荷控制水平、緩衝液容量和緩衝液特性。我們的 Millipore Express® 和 Milligard® PES（非 PFAS）緩衝過濾器都能以合理的成本提供高流量和高容量，並具有細菌截留規格，可針對您特定的製程需求提供適當的生物負荷控制等級。此外，為了簡化您的風險評估並簡化合規性，我們的過濾產品組合受到Emprove® Program的支援。如欲協助您決定製程中適用的緩衝過濾器，請與我們聯絡.
。Millipore Express®PHF（過程保護、高通量）過濾器。所有Millipore Express®膠囊式和濾芯式過濾器都含有0.2 µm PES殺菌膜，具有高通濾性、易於潤濕和完整性測試，以及廣泛的化學相容性。
如需更多堵塞緩衝劑，Millipore Express® SHC（無菌、高容量）過濾器是更好的選擇。這些過濾器內含整合式 0.5 µm 聚醚砜 (PES) 膜預過濾器，可保護 0.2 µm PES 滅菌膜，最大化過濾容量。
- Millipore Express® SHF 和 Millipore Express® SHC 過濾器應用於需要無菌保證的關鍵製程緩衝步驟。
- Millipore Express® PHF 過濾器是一種低成本、無菌緩衝液過濾選項，適用於不太重要、可能不需要無菌保證的緩衝液製程步驟。
BIOBURDEN REDUCTION BUFFER FILTERS
Milligard® PES 過濾器可用作減少生物負荷緩衝過濾器。這些過濾器具有流速快、通量高、易於潤濕和完整性測試以及廣泛的化學相容性等優點，是一種具有成本效益的緩衝過濾選擇。
有兩種孔徑可供選擇，各有不同的減少生物負荷規格：
- Milligard® PES 1.2/0.2 µm 標稱：根據 ASTM F838 方法，通常去除率≥ 6 log Brevundimonas diminuta
- Milligard® PES 1.2/0.45 µm：基於 ASTM D3863 和 F838 方法，典型值≥ 6 log Serratia marcescens 清除率
膠囊式和濾芯式過濾器的近似過濾面積。完整資訊請參閱產品規格。請閱讀我們的技術文章，以獲得更多關於不同過濾器格式.
的資訊。品質標準與文件
所有 Millipore Express® 和 Milligard® 過濾器的設計、開發和製造均符合 ISO 9001 品質系統標準。和 Milligard® 所有 PES 過濾器的設計、開發和製造均符合 ISO 9001 品質系統標準，並獲得品質證書。
Millipore Express® SHF、Millipore Express® SHC和Milligard® PES過濾器獲得Emprove® .計劃提供三種類型的檔案資料，以支援不同階段的開發和製造作業，例如資格認證、風險評估和製程最佳化。這些檔案將特定產品的全面測試資料、品質聲明和法規資訊整合成一種容易取得的格式，讓您可以放心地向前邁進。
相關資源
- Aseptic Filter Formats: Selection Guide
This technical article provides a high level overview of different formats available to help guide product selection.
- 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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