0.1µm AseptiCap® KS-γ Inline
MDI AseptiCap® KS-γ are specially designed filters for process development and formulation development labs with identical materials of construction for easy scale up to larger capsule filters and cartridge filters. 50mm is a special vented device for use with peristaltic pump to ensure easy removal of entrapped air in upstream. These are validated for mycoplasma removal and are gamma sterilizable with up to 50 kGy for ready to use disposable assemblies.
- 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 | Gamma Stable 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) – ¼” SHB |
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| Dimension (End to End) – ¾” Sanitary Flange Inlet I/O |
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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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| 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 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 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 | ||
AseptiCap® KS- γ (25mm)
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*Gamma sterilized filters cannot be gamma irradiated again
**Female Luer Lock is available as Inlet only
***Male Luer Slip is available as Outlet only
Example:
| IKSX | 06 | 36 | MN | R | X | 1 | 04 |
Example for Non Sterile: IKSX0636MNRX104 Example for Gamma Sterile: IKSX0636MNXX304
AseptiCap® KS- γ (50mm)
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* Gamma irradiated filters can not be gamma sterlized again
**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 | R | X | 1 | 02 |
Example for Non Sterile: VKSX1036BBRX102 Example for Gamma Sterile: VKSX1036BBXX302
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