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.
Mini Kleenpak 20 capsules are suited to both the filtration of low volumes of fluids (50 mL to 2 L) in the laboratory for filterability purposes, or in a GMP production environment where a certified filter product is essential and a single-use alternative to the cleaning of 47 mm disc holders is desired.
Key Features and Benefits
-
Highest flow of PVDF compared to other 0.1 µm filters
-
Built in prefiltration layer
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High safety for A. laidlawii
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Sterilizing grade claim
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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
-
不含树脂和表面活性剂
-
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
-
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
|
Filter Membrane |
Hydrophilic modified PVDF |
Housing, Vent Plug and Support Material |
Polypropylene (Filling Bell is polycarbonate) |
Sealing Technology |
Thermal bonding without adhesives |
|
Operating Parameters¹
|
Maximum Operating Temperature and Pressure |
1.4 bar (20 psi) at 20 °C |
|
¹ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction
Sterilization²
|
Pre-sterilized, subject to a minimum of 25 kGy of gamma irradiation |
|
² Pre-sterilized Mini Kleenpak 20 capsules must not be re-sterilized.Mini Kleenpak 20 capsules must not be sterilized in-situ by passing steam under pressure
Typical Hold up Volume
Nominal Dimensions
|
Capsule Length |
83 mm (3.3 in.) |
Capsule Diameter |
67 mm (2.7 in.) |
|
Nominal Effective Filter Area (EFA)
连接
|
¼ – ½ in. (6 – 13 mm) stepped hose barb.Inner bore to accept female slip luer interior and outer diameter to accept filling bell outlet |
|
|
配Fluorodyne II DJL 膜的小型 Kleenpak 20 囊式过滤器 |
KM5DJLP2S* |
|
* supplied as 1 box of 3 filters