Fluorodyne® II DFL - Kleenpak™ Capsules
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Description
These validated 0.2 micron-rated sterilizing grade filters retain Brevundimonas diminuta (ATCC 19146) at 107 CFU/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.
Kleenpak capsules are rugged and compact, can be supplied with a broad range of filter media, and can be offered in up to four different filter area sizes designed for a variety of applications in pharmaceutical manufacturing environments (volumes of 30 L to 1000 L) from small to large-scale. 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
- Resin and surfactant-free
- 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
- Material of Construction
- Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
Specifications
¹ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction
² Pre-sterilized Kleenpak capsules must not be re-sterilized. Kleenpak capsules must not be sterilized in-situ by passing steam under pressure
³ Tested on capsules without pre-flushing
Materials Of Construction
| Filter Membrane | Hydrophilic modified PVDF |
|
Support/Drainage |
Polypropylene Polypropylene Polypropylene |
| Sealing Technology | Thermal bonding without adhesives |
Operating Parameters¹
| Maximum Operating Temperature | 40 °C |
| Maximum Operating Pressure | 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) |
Application
Filters - Liquid - Sterile (0.2 micron)
