0.1µm AseptiCap® KS Large
MDI AseptiCap® KS PES membrane capsule filters are validated for mycoplasma removal and are used for sterile media filtration in mammalian cell culture. The filters meet key process requirements such as high retention efficiency, very high protein recoveries, extremely low extractables, high throughputs, wide chemical compatibility etc.
- Absolute retention
- 100% integrity tested
- Low protein binding
- Very low hold up volume in filters
- High flow rates
- Serial construction with prefilter for higher throughput with fouling streams
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Widest range of end connections
- Products available for total scalability from a few ml to thousands of liters
- Total traceability through unique serial number for each filter
- Individual certificate of quality for each device
- Sterilizable by EO gas or autoclaving
Sterile Filtration of:
- Cell culture media
- Cell culture media containing serum
- Media additives
- Final product concentrates
| Construction | |||||
| Membrane | 0.1 μm Hydrophilic PES | ||||
| Prefilter Membrane | 0.2 μm or 0.45 μm Hydrophilic PES | ||||
| Support Layers | Polyester | ||||
| Plastic parts | 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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| Dimensions (End to End) Inline Capsule Filters – 1½” Sanitary Flange I/O |
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| Dimensions (End to End) Inline Capsule Filters – ½” Single Step Hose Barb I/O |
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| Clean Water Flow Rate @ 10 psi with 1½” Sanitary Flange connection |
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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 | > 26 psi (1.82 Kg/cm²) with 50% IPA
> 65 psi (4.56 Kg/cm²) with Water |
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| Max. Air Diffusion Flow (@ 50psi (3.51 Kg/cm²) with water) |
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| Bacterial Retention | LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area
LRV> 7 for Brevudimonas diminuta ATCC 19146 per cm² of filter area as per ASTM F 838 |
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| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||||
| Max. Differential Pressure | 60 psi (4 Kg/cm²) @ 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 it cannot be in-line steam sterilized | ||||
| Shelf Life | 3 years after EO 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 as per USP <85> | ||||
| 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 | ||||
| TOC and Conductivity | Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 3 liter flush | ||||
| Particle Release | Passes USP test for particulates in injectables | ||||
| 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> | ||||
| Oxidizable Substances | Within limits as specified in USP <1231> | ||||
| Particle Shedding | Passes USP test for particulates in injectables. | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*1″ hose barb and 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 | 36 | EE | X | X | 1 | 01 |
Example for Non Sterile: LKSX5436EEXX101 Example for EO Sterile: LKSX5436EEXX201
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