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0.1µm AseptiCap® KS-γ Large
MDI AseptiCap® KS-γ PES membrane capsule filters are validated for mycoplasma removal and are used for sterile media filtration in mammalian cell culture.
These are gamma sterilizable and are available in a wide range of sizes and end connections.
- 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
- pH adjusters
| Construction | |||||
| Membrane | 0.1 µm Hydrophilic PES | ||||
| Prefilter Membrane | 0.2µm or 0.45µm Hydrophilic PES | ||||
| Support Layers | Polyester | ||||
| Plastic parts | Gamma Stable 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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| Dimension (End to End) – 1″ Hose Barb I/O |
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| Operational Radius (with Vent/ Drain) |
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| Clean Water Flow Rate @ 10 psi with 1½” Sanitary Flange Connection |
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| Vent and Drain |
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| Integrity Testing / Retention | |||||
| 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 | ||||
| Bubble Point | > 26 psi (1.82 Kg/cm²) with 50% IPA
> 65 psi (4.56 Kg/cm²) with Water |
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| 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 | ||||
| TOC and Conductivity | 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 | ||||
| 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 | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
| pH Compatibility | Compatible with pH range of 1-10 | ||||
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*Gamma sterilized filters cannot be gamma irradiated again
**1” Hose Barb and T-line are 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 | R | X | 1 | 01 |
Example for Non Sterile: LKSX5336EERX101
Example for Gamma Sterile: LKSX5336EEXX301
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