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 | ||||
| Integrity Testing / Retention | |||||
| Bubble Point | > 50psi (3.52Kg/cm²) with Water | ||||
| Microbial Retention | LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² | ||||
| 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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| 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 |
