Description
Sterilizing-Grade Filters for Cell Harvest Material and Final Bulk Biological Process Fluids
Offered in a range of scalable formats, Fluorodyne EX grade EDF membrane filters feature a unique membrane pairing. These filters are most effective when filtering high-fouling feeds for which conventional dual-layer filters may have insufficient capacity, including:
- Downstream processing: sterile filtration of clarified cell harvest
- Formulation and filling: sterile filtration of nanosuspensions such as liposomes and emulsions
Superior Performance
Fluorodyne EX EDF membrane filters have a 0.2 µm removal rating and incorporate a high-capacity asymmetric polyethersulfone (PES) prefilter layer over a polyvinylidene fluoride (PVDF) membrane layer.
Benefits From Using Fluorodyne EX Grade EDF Filters
- Very low protein and preservative binding
- Fast and easy scale-up: all process development-scale filter formats are designed to scale directly to larger cGMP filter configurations
- Low extractables
- Exceptional throughput due to unique cartridge construction results in compact filter systems
Security of Supply and Reliability of Performance
Pall manufactures the PES and PVDF membranes used in Fluorodyne EX grade EDF filters. All Fluorodyne EX EDF filters are made at manufacturing sites in Puerto Rico and the United Kingdom.
Scientifically Validated
With a removal rating of 0.2 µm in liquids, Fluorodyne EX grade EDF filters are validated by bacterial liquid challenge using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) at a challenge level of 107 cfu/cm2, supported with comprehensive validation data.
Specifications
膜片过滤器
| 规格 | 有效过滤面积 (EFA) (cm2) |
典型批量 (L) | 灭菌条件 |
| 47 mm Discs | 14 | 0.05 – 2 | 高压灭菌 |
囊式过滤器
| 规格 | 有效过滤面积 (EFA) (cm2) |
典型批量 (L) | 灭菌条件 |
| Mini Kleenpak™ Syringe Filters | 2.8 | Up to 0.1 | 通过伽玛辐照进行了预灭菌 |
| Mini Kleenpak 20 Capsules | 20 | 0.05 – 2 | 通过伽玛辐照进行了预灭菌 |
| Mini Kleenpak Capsules | 240 | 2 – 50 | 高压灭菌：135 ℃ 下为 3 × 30 分钟； 伽玛辐照：最大 50 kGy |
| Kleenpak Capsules | 750 | 2 – 120 | 高压灭菌：135 ℃ 下为 3 × 60 分钟； 伽玛辐照：最大 50 kGy |
| Kleenpak Nova Capsules | 5,300 – 11,000 | 50 – 1,000 | 高压灭菌：135 ℃ 下为 3 × 60 分钟； 伽玛辐照：最大 50 kGy |
滤芯
| 规格 | 有效过滤面积 (EFA) (cm2) |
典型批量 (L) | 灭菌条件 |
| Filter Cartridges | 5,300 – 11,000 | 100 – 1,000 | 高压灭菌：135 ℃ 下为 5 × 60 分钟 在线蒸气灭菌：135 ℃ 下为 5 × 60 分钟 |
质量放行标准
| 47 mm Discs | Mini Kleenpak Syringe Filters |
Mini Kleenpak 20 Capsules |
Mini Kleenpak Capsules | Kleenpak Capsules | Kleenpak Nova Capsules | Filter Cartridges | |
| 按照 ISO 9000 质量管理体系认证标准进行设计、开发和制造 | ● | ● | ● | ● | ● | ● | ● |
| 工艺开发 | ● | ● | ● | ● | ● | ||
| 制造等级 – cGMP | ● | ● | ● | ● | ● | ||
| 定量滤膜起泡点 | ● | ● | ● | ● | ● | ● | ● |
| 生产过程的完整性测试方案（仅批次） | N/A | ● | ● | ||||
| 生产过程的完整性测试方案 - 每个过滤器均 100％ 进行测试 | N/A | ● | ● | ● | ● | ||
| 与微生物截留测试相关联 | ● | ● | ● | ● | ● | ● | ● |
| 符合 VI-121 °C 级塑料的 USP 体内生物反应性试验要求 | ● | ● | ● | ● | ● | ● | ● |
| 随附一份制药级证书("P"级证书) | ● | ● | ● | ● | ● | ● | |
