0.1µm AseptiCap® KS Inline
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
- pH adjusters
- Final product concentrates
Bioburden Reduction/ Particulate Removal:
- Buffers
- Centrifuge supernatants
- Clarified cell lysates
| Construction | |||
| Membrane | 0.1 μm Hydrophilic PES | ||
| Prefilter Membrane | 0.2 μm or 0.45 μm Hydrophilic PES | ||
| Plastic parts | Polypropylene | ||
| Size | |||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) – Female Luer Lock Inlet/ Male Luer Slip |
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| Dimension (End to End) – ¾” Sanitary Flange Inlet I/O |
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| Dimension (End to End) – ¼” SHB |
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| Operational Radius (with Vent/ Drain) |
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| 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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| 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 | |||
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| 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, 3 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 500ml flush | ||
| Particle Release | Passes USP test for particulates in injections | ||
| Indirect Food Additive | All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR Part 177.1520 | ||
| Extractables with WFI | Passes NVR test as per USP <661> | ||
| Oxidizable Substances | Passes test as per USP <1231> | ||
| Quality Management System | ISO-9001 Certified | ||
| USFDA | DMF No. 015554 | ||
AseptiCap® KS (25mm)
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*Female Luer Lock is available as Inlet only
**Male Luer Slip is available as Outlet only
Example :
| IKSX | 06 | 36 | MN | X | X | 1 | 04 |
Example for Non Sterile: IKSX0636MNXX104 Example for EO Sterile: IKSX0636MNXX204
AseptiCap® KS (50mm)
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*¼” Stepped Hose Barb and ¾” Sanitary Flange are available in filters with vent only
**¼” Single Step Hose Barb and Female luer lock is available in filters without vent only
Example :
| VKSX | 10 | 36 | SS | X | X | 1 | 02 |
Example for Non Sterile: VKSX1036SSXX102 Example for EO Sterile: VKSX1036SSXX202
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