特色及优点
- Filter elements are 100% integrity and capsules are 100% pressure tested
- 0.2 micron sterilizing-grade
- 低蛋白结合率
- 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
材料成分
| 膜 | Nylon 6,6 Bio-Inert |
| Support and Drainage | 聚酯 |
| Core and Cage | Polypropylene or polyester |
| Endcaps and Shell | 聚酯 |
| O 型圈 | 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 上海羽令
有效过滤面积
| 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.
| 描述 | 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 |
