These 0.1 micron-rated filters with serial layer (0.2/0.1 micron) membrane construction assure high flow rates compared with other 0.1 micron (and even some 0.2 micron)-rated filters.Fluorodyne II grade DJL filters are validated for removal of
Acholeplasma laidlawii mycoplasma (ATCC 28206) with a typical T
R >10
11 and retention of
Brevundimonas diminuta (ATCC 19146) at 10
7 CFU/cm² effective filter area (EFA).This allows for enhanced sterilization assurance as well as efficient mycoplasma control.
若无大型过滤器（工艺容量 2 升至 50 升）工艺要求，则小型 Kleenpak 囊式过滤器可用于实验室工艺开发和中试级生产规模运营。They are the smallest capsule filters with a pleated membrane in 颇尔’s UpScale range and are excellent for modeling filter performance at large production scale
Key Features and Benefits
-
Encapsulated format for higher flexibility, minimized cleaning and low installation costs
-
Minimal hold up volume
-
Ideal for scale-up trials
-
Highest flow of comparable PVDF filters
-
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
囊式过滤器
Filling Bell
|
聚丙烯
聚丙烯
聚碳酸酯 |
|
Sealing Technology |
Thermal bonding without adhesives |
|
|
Operating Parameters¹
|
|
|
Maximum Operating Temperature |
40 °C |
|
最大操作压力 |
4.1 bar (60 psi) at 40 °C |
|
Maximum Differential Pressure (Forward Direction) |
4.1 bar (60 psi) at 40 °C |
|
|
¹ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction
Sterilization²
|
|
|
Autoclave (G option only) |
3 x 60 minutes at 125 °C |
|
Gamma Irradiation (G option only) |
Maximum of 50 kGy |
|
|
² Pre-sterilized Mini Kleenpak capsules must not be re-sterilized. Mini Kleenpak capsules must not be sterilized in-situ by passing steam under pressure
Typical Extractables in Water at 20 °C³
|
|
|
G option only |
< 1 mg |
|
S option only |
< 5 mg |
|
|
³ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction
Nominal Dimensions
|
|
|
Maximum diameter including valves |
41 mm (1.6 in.) |
|
Length - Code 2 |
105 mm (4.1 in.) |
|
Length - Code 8 |
73 mm (2.9 in.) |
|
|
Nominal Effective Filter Area (EFA)
