0.1μm AseptiPrime® KS-γ 1", 2", 5", 8"
AseptiPrime® KS-γ capsule filters use mdi PES membrane in gamma compatible polypropylene housing. No adhesives or glue are used in the manufacturing process and all bonding is done by heat welding.The products are deeply validated for use in biopharmaceutical applications.
AseptiPrime® KS-γ are manufactured in class 10,000 clean rooms and ISO 9001 certified facilities. Packaging is done in double polybags for direct irradiation by gamma or for convenience of taking AseptiPrime® KS-γ in clean areas for making disposable assemblies for subsequent sterilization.
- Very high throughput
- Absolute retention
- 100% integrity tested
- Low protein binding
- Very low hold up volume in filters
- High flow rates
- 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 Gamma irradiation or autoclaving (1 cycle)
Sterile Filtration of :
- Cell culture media
- Cell culture media containing serum
- Media additives
- Final product concentrates
| Construction | |||||
| Membrane | Hydrophilic PES | ||||
| Final Filter Pore Size | 0.1 μm | ||||
| Prefilter Membrane | 0.3μm or 0.5μm PES | ||||
| Support Layers | Polyester | ||||
| Plastic parts | Gamma Stable Polypropylene | ||||
| Size | |||||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimensions (End to End) - 1½" Sanitary Flange I/O |
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| Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet |
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| Dimension (End to End) - ¼" SHB I/O |
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| Dimension (End to End) - ¾" Sanitary Flange Inlet I/O |
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| Dimension (End to End) - ½" Hose Barb I/O |
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| Dimension (End to End) - ½" Single Step Hose Barb I/O |
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| Clean water Flow Rate @ 10 psi with ½" Hose Barb Connection |
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| Operational Radius (with Vent/ Drain) |
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| Vent and 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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| Max. Air Diffusion Flows (10") | < 29 ml/min @ 50 psi (3.52 Kg/cm²) with water | ||||
| Microbial Retention | LRV >7 for Acholeplasma laidlawii (ATCC 23206) per cm² | ||||
| 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 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 | ||||
| Hold-up Volume |
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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 | ||||
| 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 | ||||
| Indirect Food Additive | Comply with USFDA 21 CFR Part 177.1520 | ||||
| Extractables with WFI | Passes test as per USP | ||||
| Oxidizable Substances | Within limits as specified in USP | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*Single step ½” Hose Barb and 3/8" Hose Barb is not available in 1” Capsule Filters.
**Male luer slip is available only in 1” capsule filter as outlet
***3/16" Hose Barb end connection is available in:
- 1" and 2" capsule filters as inlet and outlet
- 5" capsule filters as outlet only
****Gamma irradiated capsule filters cannot be gamma sterilized again
Example:
| DKX7 | 57 | 36 | DD | R | X | 1 | 01 |
Example for Non Sterile: DKX75136QQRX101 Example for Gamma Sterile: DKX75136QQXX301
