0.2µm AseptiCap® KL/KS-γ 1", 2", 5", 8"
mdi AseptiCap® KL/KS- γ PES membrane capsule filters are available in a wide range of pore sizes, sizes and end connections to suit a multitude of sterilization applications in biopharmaceuticals for process development, pilot scale and production batch sizes. These are gamma sterilizable up to 50 KGy for ready to use gamma sterilized disposable assemblies.
| Consistent and Reliable Quality: | AseptiCap® capsule filters are produced with ISO 9001 certified quality management systems. |
| Regulatory Compliance: | Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554 |
| Low Protein Binding: | Results in increased overall product yield |
| High Throughputs: | Translates to lower filtration costs, less number of filter changes and overall economy of operations. |
| Low Extractables: | Mean less addition to impurity profile of the biological product from the filters. |
- Bioburden reduction from cell harvest supernatants
- Filtration of equilibrating, washing and elution buffers for chromatography columns
- Sterilization of biopharmaceuticals such as vaccines and therapeutic proteins
- Sterilization of buffers
- Sterilization of adjuvants
| Construction | |||||
| Membrane | Hydrophilic PES | ||||
| Final Filter Pore Size | 0.2µm | ||||
| Support Layers | Polyester | ||||
| Body and Core | Polypropylene | ||||
| Prefilter Pore Size (in case of AseptiCap KS- γ) | 0.8µm, 0.65µm, 0.45µm | ||||
| Size | |||||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimensions (End to End) - 1½" Sanitary Flange I/O |
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| Dimension (End to End) - ½" Hose Barb I/O |
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| Dimension (End to End) - ¾" Sanitary Flange I/O |
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| Dimension (End to End) - ½" Single Step Hose Barb I/O |
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| Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet |
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| Operational Radius (with Vent/ Drain) |
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| Vent and Drain |
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| Integrity Testing / Retention | |||||
| Bubble Point | > 50psi (3.52Kg/cm²) with Water | ||||
| Microbial Retention | LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² | ||||
| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 2 Kg/cm² (30 psi) | ||||
| Max. Differential Pressure | < 4 Kg/cm² (60 psi) @ 30 °C | ||||
| pH Compatibility | Compatible with pH range of 1-10 | ||||
| Sterilization By Irradiation | Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized. | ||||
| Shelf Life | 2 years after gamma sterilization | ||||
| Assurance | |||||
| Toxicity | Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics | ||||
| Cytotoxicity | Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity | ||||
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test | ||||
| Bioburden | Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 : 2018 | ||||
| Non Fiber Releasing | Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release | ||||
| Indirect Food Additive | All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 | ||||
| Extractables with WFI | Passes NVR test as per USP <661> | ||||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices | ||||
| Oxidizable Substances | Within limits as specified in USP <1231> | ||||
| Particle Shedding | Passes USP test for particulates in injectables | ||||
| TOC/Conductivity at 25 °C | Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 3 liter flush | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*0.45µm upstream is available with 0.2µm pore size only
**1” Capsule Filters are not available with ½” Single step Hose Barb, ½” MNPT and 3/8" Hose Barb
***3/16" Hose Barb end connection is available in:
- 1" and 2" capsule filters as inlet and outlet
- 5" capsule filters as outlet only
****Male luer slip is available only in 1” capsule filter as outlet
*****Gamma sterilized filters cannot be gamma irradiated again
******Bell and bell with cover is available with:
- ½" Hose Barb outlet connections in 1", 2", 5" and 8" capsule filters
- ¼" SHB outlet connection in 1" capsule filters only
Example:
| DKSX | 57 | 01 | DD | R | X | 1 | 01 |
Example for Non Sterile: DKLX5101QQRX101 Example for Gamma Sterile: DKLX5101QQXX301
