颇尔's standard AB-style filters are replaceable cartridges used with stainless steel housing assemblies, suitable for medium-to-large-scale manufacturing operations (100 L to > 1000 L).With Code 7 fittings as standard, these cartridges are the most versatile filtration units in 颇尔's product range, and are available with a broader range of filtration media than any other filter type.These cartridges are also available encapsulated in the Kleenpak™ Nova capsule format.
特色及优点
- Intrinsically water wettable
- Fixed pores, non-shedding
- 不含树脂和表面活性剂
- 广泛的溶剂兼容性
- Low filter extractables
- High-area for long-life
- Low protein-binding for excellent product transmission
- 可在线重复进行蒸汽灭菌
Quality and Bio-Safety*
Integrity
（正直诚信）
- Every filter integrity tested during manufacture, test correlated to microbial retention
Biological Tests
- Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
- Meets Cleanliness per USP Particulates in Injectables
- Non-Fiber-Releasing per 21 CFR
- Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)
- Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water
Steam Resistance
- Lot samples multi-cycle autoclave challenged
* Per lot samples soak or rinse-up flush aliquots.
材料成分
| 膜 | Nylon 6,6, double-layer |
| Support.Drainage and End Caps | 聚酯 |
| Core and Cage | 聚丙烯 |
| O 型圈 | Silicone¹ |
Microbial Removal Ratings²
| NRL, NFL | 0.2 µm sterilizing-grade |
| NT | 0.1 µm mycoplasma sterilizing-grade |
Nominal Dimensions
| Lengths | 254 mm (10 in.), 508 mm (20 in.) |
| Diameter | 70 mm (2.75 in.) |
Operating Conditions³
| Maximum Differential Pressure during Steam-Sterilization | 300 mbar (4.35 psi) in a forward direction |
| Maximum Differential Pressure and Temperature |
5.5 bard (80 psid) to 50 °C 4.1 bard (60 psid) to 80 °C |
Typical Liquid Flow Rates4
Configuration (AB Code 7)5
|
Double 226 O-ring adapter Fin end with bayonet lock |
Autoclavable or Steamable In-situ6
| Cumulative Steam Exposure |
16 hours (1-hour cycles) at 121 °C 4 hours (1-hour cycles) at 140 °C |
Aqueous Extractables (NVR) per 254mm (10 in.)滤芯
|
Typically 15 – 25 mg |
| Part Number1 | 描述 |
| AB1NFL7PH4 |
Bio-Inert Membrane Filter Cartridge, Grade NFL Nominal length 254 mm (10 in.);颇尔 Code 7 double O-ring, bayonet lock and fin |
| AB2NFL7PH4 |
Bio-Inert Membrane Filter Cartridge, Grade NFL Nominal length 508 mm (20 in.);颇尔 Code 7 double O-ring, bayonet lock and fin |
| AB1NRL7PH4 |
Bio-Inert Membrane Filter Cartridge, Grade NRL Nominal length 254 mm (10 in.);颇尔 Code 7 double O-ring, bayonet lock and fin |
| AB2NRL7PH4 |
Bio-Inert Membrane Filter Cartridge, Grade NRL Nominal length 508 mm (20 in.);颇尔 Code 7 double O-ring, bayonet lock and fin |
| AB1NT7PH4 |
Bio-Inert Membrane Filter Cartridge, Grade NT Nominal length 254 mm (10 in.);颇尔 Code 7 double O-ring, bayonet lock and fin |
| AB2NT7PH4 |
Bio-Inert Membrane Filter Cartridge, Grade NT Nominal length 508 mm (20 in.);颇尔 Code 7 double O-ring, bayonet lock and fin |
1 All configurations shown are pharmaceutical-grade filters designed for use in conformance with CGMP in manufacturing, processing, packing or holding of drugs (21 CFR 210) and CGMP for finished pharmaceuticals (21 CFR 211.72) including batch release certificate and full traceability.For non-pharmaceutical grade filters, omit the letter P from the part number, e.g. AB1NFL7H4
