with a typical titer reduction (TR) of > 106 ensures that they are also suitable for bioburden control.A serial layer (0.65/0.45 micron) membrane construction allows for high throughputs and high flow rates compared with other 0.45 micron-rated filters.
Kleenpak 囊式过滤器坚固耐用且体积小巧，可提供多种过滤介质，并有 4 种过滤面积尺寸以满足小型到大型的规模制药生产环境中的多种应用需求（容量为 30 升至 1000 升）。These in-line single-use assemblies are available with sanitary or hose barb inlet/outlet fittings.
Key Features and Benefits
- Encapsulated format for higher flexibility, minimized cleaning and low installation costs
- Built in prefiltration
- Minimal hold up volume
- Low extractables
- High protein transmission
- Rapid preservative recoveries
- Easy integrity testing
- Compatible with organic solvents, acids and chemicals¹
- 不含树脂和表面活性剂
-
Melt-sealed, non shedding
¹ Except ketones and amides
Quality Standards
- Manufactured for use in conformance with cGMP
- 100 % integrity tested
- ISO 9000 Certified Quality System
- Meets USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
- Every filter tested during manufacture
- Test correlated to microbial retention
-
Certificate of Test provided includes
- Fabrication Integrity
- Bacterial Retention
- 材料成分
- Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
材料成分
| Filter Membrane | Hydrophilic modified PVDF |
|
Support/Drainage |
聚丙烯 聚丙烯 聚丙烯 |
| Sealing Technology | Thermal bonding without adhesives |
Operating Parameters¹
| Maximum Operating Temperature | 40 °C |
| 最大操作压力 |
5.2 bar (75 psi) at 20 °C 4.0 bar (58 psi) at 40 °C |
| Maximum Differential Pressure (Forward Direction) | 4.0 bar (58 psi) at 40 °C |
Sterilization²
| Autoclave (G and blank option only) |
30 x 60 minutes at 125 °C 10 x 60 minutes at 140 °C |
| Gamma Irradiation (G option only) | Maximum of 50 kGy |
Typical Extractables in Water at 20 °C³
| < 5 mg per capsule |
Nominal Dimensions
| KA1 | KA2 | KA3 | KA4 | |
| Diameter incl.Valves | 94 mm (3.7 in.) | 94 mm (3.7 in.) | 105 mm (4.1 in.) | 105 mm (4.1 in.) |
| Length - Code 1 | 117 mm (4.6 in.) | 157 mm (6.2 in.) | 174 mm (6.8 in.) | 287 mm (11.3 in.) |
| Length - Code 2 | 158 mm (6.2 in.) | 198 mm (7.8 in.) | - | - |
| Length - Code 6 | 157 mm (6.2 in.) | 197 mm (7.7 in.) | 210 mm (8.3 in.) | 327 mm (12.8 in.) |
| Length - Code 12 | 137 mm (5.4 in.) | 177 mm (7.0 in.) | - | - |
| Length - Code 16 | 137 mm (5.4 in.) | 177 mm (7.0 in.) | 192 mm (7.6 in.) | 305 mm (12.0 in.) |
Nominal Effective Filter Area (EFA)
| KA1 | 400 cm² (0.4 ft²) |
| KA2 | 800 cm² (0.9 ft²) |
| KA3 | 1500 cm² (1.6 ft²) |
| KA4 | 3300 cm² (3.6 ft²) |
