0.1μm 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
Construction | |||||
Final Filter Membrane | 0.1μm Polyethersulfone | ||||
Prefilter Membrane | 0.3 μm or 0.5 μm Asymmetric Hydrophilic PES | ||||
Support Layers | Polyester | ||||
Plastic parts | 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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Dimension (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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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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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 Gas | Sterilizable by Ethylene Oxide | ||||
Sterilization By Autoclave | Autoclavable at 125°C for 30 minutes, 3 cycles. Can not 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 | ||||
Microbial Retention | LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area | ||||
Non Fiber Releasing | Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release | ||||
Particle Release | The filtrate complies with USP <788> test for particulate matter 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 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 | ||||
TOC/Conductivity at 25 °C | Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 3 liter 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
**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” HB outlet connections in 1”, 2”, 5” and 8” capsule filters
- ¼” SHB outlet connection in 1” capsule filters only
Example:
DKX9 | 51 | 36 | AA | X | X | 1 | 01 |