0.2µm AseptiCap® KS 5", 10", 20", 30"
mdi AseptiCap® KS PES membrane large capsule filters are available in a wide range of pore sizes, sizes and end connections to suit a multitude of sterilization applications in biopharmaceuticals production processes.
| 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 | 0.2 μm | ||||
| Prefilter Pore Size | 0.8 µm, 0.65 µm, 0.45 µm | ||||
| Support Layers | Polyester | ||||
| Body and Core | Polypropylene | ||||
| Size | |||||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet |
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| Dimension (End to End) - ¾" Sanitary Flange I/O |
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| Dimension (End to End) - 1½" Sanitary Flange I/O |
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| Dimensions (End to End) - ½" Single Step Hose Barb I/O |
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| Dimension (End to End) - 1" Hose Barb I/O |
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| Operational Radius (with Vent/ Drain) |
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| Dimension (End to End) - 3/8" Hose Barb I/O |
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| Vent and Drain | ¼" Hose Barb with Silicone "O" rings | ||||
| Integrity Testing / Retention | |||||
| Bubble Point | > 50psi (3.52Kg/cm²)with Water | ||||
| Max. Air Diffusion Flows (10") |
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| 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 Gas | Sterilizable by Ethylene Oxide | ||||
| Sterilization By Autoclave | Autoclavable at 125°C for 30 minutes, 25 cycles and cannot be in-line steam sterilized | ||||
| Shelf Life | 3 years after EO sterilization |
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| 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 10 liter flush for 5” capsule filters and 20 liter flush for 10” capsule filters | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*T-line is not available in 5" Capsule filter
*T-line Capsule filter are available with 1½" Sanitary Flange I/O connection only
***3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filters
Example :
| LKSX | 54 | 01 | EE | X | X | 1 | 01 |
