特色及优点
- Intrinsically water wettable
- Fixed pores, non-shedding
- 不含树脂和表面活性剂
- Low filter extractables
- High-area for long-life
- 广泛的溶剂兼容性
- High protein recovery from most protein solutions
- 可在线重复进行蒸汽灭菌
- Manufactured for use in conformance with cGMP
- ISO 9000 Certified Quality System
- Pharmaceutical P optimized
- Certificate of Test provided
- Double open-ended (DOE) available
-
FDA-listed materials per 21 CFR
注意事项:These filters are also available in Kleenpak Nova capsule format.
Quality and Bio-Safety
Biological Tests
- Meets USP Biological Reactivity test,in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests (AB Style)*
- Meets Cleanliness per USP Particulates in Injectables
- Non-Fiber-Releasing
- Non-Pyrogenic per USP
-
Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots.
Materials of Constructions
膜 | 尼龙 6,6 |
Support, Drainage and End Caps | 聚酯 |
Core and Cage | 聚丙烯 |
O 型圈 | Silicone1 |
Microbial Removal Ratings
NK | 0.65 µm particulate rated |
NB | 0.45 µm microbial-rated (Typical Serratia marcescens TR > 104 – 6) |
NX, NL | 0.45 µm microbial-rated (Lot samples retain > 107/cm2 Serratia marcescens) |
钠 | 0.2 µm microbial-rated (Typical Brevundimonas diminuta TR > 104 – 6) |
Nominal Dimensions
Lengths | 254 mm (10 in.), 508 mm (20 in.), 762 mm (30 in.), 1016 mm (40 in.) |
Diameter | 70 mm (2.75 in.) |
Configuration (AB Code 7)2
Double 226 O-ring adapter Fin end with bayonet lock |
Operating Conditions3
Maximum Differential Pressure and Temperature |
5 .5 bard (80 psid) to 50 °C 4.1 bard (60 psid) to 80 °C 2.1 bard (30 psid) to 125 °C |
Typical Flow Rates 4
4 Typical initial clean media P 254mm (10 in.) element; water at 20 °C; viscosity 1 cP.For assistance in filter assembly sizing and housing selection, contact 上海羽令.
Autoclave and Steaming in situ5
Cumulative Steam Exposure |
16 hours (1-hour cycles) at 121 °C 4 hours (1-hour cycles) at 140 °C |
Aqueous Extractables (NVR) per 254 mm (10 in.)滤芯
Typically < 15 – 20 mg |