0.2µm AseptiPrime® KS 1", 2", 5", 8"
mdi AseptiPrime® KS are sterilizing grade PES membrane capsule filters specially designed for very high throughput.
It incorporates a highly asymmetric PES membrane prefilter to provide enhanced protection to the well proven and widely accepted sterilization grade final mdi PES membrane.
These are available in a wide range of sizes and end connections to suit a multitude of sterilization applications in biopharmaceuticals for process development,pilot scale and production batch sizes.
AseptiPrime® KS filters meet key process requirements such as absolute retention, high protein recoveries and low extractables.
- Absolute retention
- 100% integrity tested
- Low protein binding
- Low extractables
- Very low hold up volume in filters
Sterile Filtration of:
- Cell culture media
- Cell culture media containing serum
- Media additives
- Buffers
- pH adjusters
- Final product concentrates
- Small volume parenterals
| Construction | |||||
| Final Filter Membrane | 0.2µm Hydrophilic PES | ||||
| Prefilter Membrane | 0.5µm Asymmetric Hydrophilic PES | ||||
| Support Layers | Polyester | ||||
| Body and Core | Polypropylene | ||||
| Size | |||||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) - ½" Hose Barb I/O |
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| Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet |
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| Dimensions (End to End) - ¾" Sanitary Flange I/O |
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| Dimension (End to End) - 1½" Sanitary Flange I/O |
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| Dimension (End to End) - ½" Single Step Hose Barb I/O |
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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 | > 50psi (3.52Kg/cm²) with Water | ||||
| Microbial Retention | LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² | ||||
| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 2 Kg/cm² (30 psi) | ||||
| Max. Differential Pressure | < 4 Kg/cm² (60 psi) @ 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, 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 | ||||
| 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 | ||||
| Indirect Food Additive | All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 | ||||
| Extractables with WFI | Passes test as per USP | ||||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices | ||||
| Oxidizable Substances | Within limits as specified in USP | ||||
| Particle Shedding | Passes USP test for particulates in injectables | ||||
| TOC/Conductivity at 25 °C | Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*1” Capsule Filters are not available with ½” Single Step Hose Barb, ½" MNPT and 3/8” hose barb connection
**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
****Bell and bell with cover is available with:
- ½” Hose Barb outlet connections in 1", 2", 5" and 8" Capsule filters
- ¼" SHB outlet connection in 1" capsule filters only
Example :
| DKX7 | 53 | 01 | DD | X | X | 1 | 01 |
