Description
Kleenpak filter capsules with low-protein-binding 0.2 micron Bio-Inert membrane are self-contained sanitary filters, designed for convenient sterilizing filtration of small-batch dilute protein solutions. They are validated to produce sterile effluent when challenged with B. diminuta (ATCC 19146) at a concentration greater than 107 CFU per cm2effective filter area of membrane (per ASTM 838-05). Incorporating two layers of intrinsically hydrophilic acrylate-modified Nylon 6,6 filter membrane, they are well suited to the microbial filtration of biological process fluids where the end user desires to minimize non-specific adsorption of proteins. Their rugged, compact design ensures reliability.
Features and Benefits
- Filter elements are 100% integrity and capsules are 100% pressure tested
- 0.2 micron sterilizing-grade
- Low protein binding
- Low filter extractables
- Sanitary vent and drain valves with non-twist hose barbs
- Low hold-up volumes
- Autoclavable version
- Manufactured for use in conformance with cGMP
Quality and Bio-Safety Biological Tests
Integrity Tests
Every filter element tested during manufacture. Test correlated to microbial retentionBiological Tests
Meets USP Biological Reactivity test, in vivo, for Class VI-121°C PlasticsEffluent Quality Tests*
- Meets Cleanliness per USP Particulates in Injectables
- Non-Fiber-Releasing
- Non-Pyrogenic per USP Bacterial Endotoxins (<0.25 EU/mL)
- Meets Total Organic Carbon and Water Conductivity per USP Purified Water
* Per lot sample or rinse-flush aliquots
Specifications
Materials of Construction
| Membrane | Nylon 6,6 Bio-Inert |
| Support and Drainage | Polyester |
| Core and Cage | Polypropylene or polyester |
| Endcaps and Shell | Polyester |
| O-rings | Ethylene Propylene (EPDM) |
Microbial Removal Rating1
| Grade NFL | 0.2 micron, sterilizing-grade |
1 Lot samples retain > 107 CFU/cm2 of Brevundimonas diminuta per modified ASTM F838-05 test
Typical Liquid Flow Rate2
| Size 1 (KA1) | 0.3 L/min |
| Size 2 (KA2) | 0.6 L/min |
| Size 3 (KA3) | 1.4L/min |
2 Typical clean filter delta P, water at 20 °C (68 °F), 1 cP. Values shown are for 11⁄2in. (38 mm) sanitary flange connections. Values with other connections are available on request. For assistance, contact your local Pall representative
Effective Filtration Area
| Size 1 (KA1) | 0.05 m2 (0.53 ft2) |
| Size 2 (KA2) | 0.1 m2 (1 ft2) |
| Size 3 (KA3) | 0.23 m2 (2.1 ft2) |
Sterilization Conditions
| Autoclave | 16 x 1-hour cycles at 125 °C (257 °F) 4 x 1-hour cycles at 140 °C (284 °F) |
Operating Conditions3
| Maximum Pressure and Temperature | 5.2 barg (75 psig) to 40 °C (104 °F) |
| Maximum Differential Pressure | 4.1 bard (60 psid) at 40 °C (104 °F) |
3 Using compatible liquids
Aqueous Extractables (NVR)4
| Size 1 (KA1) | Size 2 (KA2) | Size 3 (KA3) |
| 7 mg | 10 mg | 12 mg |
4 4 hours recirculation with water at 20 – 25 °C after autoclaving
Nominal Dimensions5
| Length (including Sanitary Connection) | Size 1 (KA1): 107 mm (4.6 in.) Size 2 (KA2): 158 mm (6.2 in.) Size 3 (KA3): 174 mm (6.8 in.) |
| Maximum Diameter of Bowl (including Valves) | Size 1 (KA1): 94 mm (3.7 in.) Size 2 (KA2): 94 mm (3.7 in.) Size 3 (KA3): 109 mm (4.2 in.) |
5 Sanitary connection is Tri-Clamp♦ compatible. Tri-Clamp is a trademark of Ladish.
Type
Filter Capsules
Ordering Information
| Description | Part Number |
| Kleenpak Capsules with Bio-Inert Membrane Size 1; 1 to 11⁄2 in. sanitary flange inlet/outlet connections | KA1NFLP1 |
| Kleenpak Capsules with Bio-Inert Membrane Size 1; 1⁄2 in. (13 mm) hosebarb inlet/outlet connections | KA1NFLP6 |
| Kleenpak Capsules with Bio-Inert Membrane Size 2; 1 to 11⁄2 in. sanitary flange inlet/outlet connections | KA2NFLP1 |
| Kleenpak Capsules with Bio-Inert Membrane Size 2; 1⁄4 to 1⁄2 in. (6 mm to 13 mm) stepped hose barb inlet/outlet connections | KA2NFLP2 |
| Kleenpak Capsules with Bio-Inert Membrane Size 2; 1⁄2 in. (13 mm) hosebarb inlet/outlet connections | KA2NFLP6 |
| Kleenpak Capsules with Bio-Inert Membrane Size 3; 1 to 11⁄2 in. sanitary flange inlet/outlet connections | KA3NFLP1 |
| Kleenpak Capsules with Bio-Inert Membrane Size 3; 1⁄2 in. (13 mm) hosebarb inlet/outlet connections | KA3NFLP6 |
Product Summary
0.2 micron rated filters, validated for sterilizing-grade applications
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