These validated 0.2 micron-rated sterilizing grade filters retain
Brevundimonas diminuta (ATCC 19146) at 10
7CFU/cm² effective filter area (EFA) and ensure very low extractables and adsorption.They are recommended for sterilizing filtration of pharmaceutical fluids including solutions with active ingredients, biologicals, biotech proteins, ophthalmics and other dilute preservative solutions.
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
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Encapsulated format for higher flexibility, minimized cleaning and low installation costs
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Minimal hold up volume
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Ideal for scale-up trials
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Highest flow of comparable PVDF filters
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Low extractables
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High protein transmission
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Rapid preservative recoveries
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Easy integrity testing
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Compatible with organic solvents, acids and chemicals¹
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不含树脂和表面活性剂
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Melt-sealed, non shedding
¹ Except ketones and amides
Quality Standards
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Manufactured for use in conformance with cGMP
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100% integrity tested
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ISO 9000 Certified Quality System
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Meets USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
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Every filter tested during manufacture
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Test correlated to microbial retention
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Certificate of Test provided includes
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Fabrication Integrity
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Bacterial Retention
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Material of Construction
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Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
材料成分
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Filter Membrane |
Hydrophilic modified PVDF |
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Support/Drainage
囊式过滤器
Filling Bell
|
聚丙烯
聚丙烯
聚碳酸酯 |
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Sealing Technology |
Thermal bonding without adhesives |
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Operating Parameters¹
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Maximum Operating Temperature |
40 °C |
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最大操作压力 |
4.1 bar (60 psi) at 40 °C |
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Maximum Differential Pressure (Forward Direction) |
4.1 bar (60 psi) at 40 °C |
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¹ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction
Sterilization²
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Autoclave (G option only) |
3 x 60 minutes at 125 °C |
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Gamma Irradiation (G option only) |
Maximum of 50 kGy |
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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
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G option only |
< 1 mg |
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S option only |
< 5 mg |
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³ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction
Nominal Dimensions
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Maximum diameter including valves |
41 mm (1.6 in.) |
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Length - Code 2 |
105 mm (4.1 in.) |
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Length - Code 8 |
73 mm (2.9 in.) |
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Nominal Effective Filter Area (EFA)
