0.2μm AseptiPrime® KS 25mm, 50mm
mdi AseptiPrime® KS are sterilizing grade PES membrane capsule filters specially designed for very high throughput.
The special asymmetric pre-filter membrane layer with high asymmetric proportion offers high loading and volume handling capacities to provide enhanced protection to the final membrane layer.
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.
Sterile Filtration of :
- Cell culture media
- Cell culture media containing serum
- Media additives
- Buffers
- pH adjusters
- Final product concentrates
- Small volume parenterals
- Absolute retention
- 100% integrity tested
- Low protein binding
- Low extractables
- Very low hold up volume in filters
Construction | |||
Membrane | Double layered Polyethersulfone with highly asymmetric prefilter membrane | ||
Final Filter Pore Size | 0.2μm | ||
Prefilter Membrane | 0.3μm or 0.5μm PES | ||
Support Layers | Polyester | ||
Plastic parts | Polypropylene | ||
Size | |||
Size |
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Effective Filtration Area |
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Dimension (End to End) - ¼" - 3/8" Stepped Hose Barb I/O |
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Dimension (End to End) - ¾" Sanitary Flange I/O |
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Dimension (End to End) - ⅛" Hose Barb I/O |
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Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip Outlet |
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Dimension (End to End) - ¼" Single Step Hose Barb I/O |
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Operational Radius (with Vent/ Drain) |
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Integrity Testing / Retention | |||
Bubble Point | > 50psi (3.52 Kg/cm²) | ||
Max. Air Diffusion Flows (10") | < 29 ml/min @ 50 psi (3.52 Kg/cm²) with water | ||
Microbial Retention | LRV>7 for Brevundimonas diminuta (ATCC 19146) per cm² | ||
Operational | |||
Max. Operating Temperature |
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Max. Differential Pressure |
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Sterilization By Gas | Sterilizable by Ethylene Oxide | ||
Sterilization By Autoclave | Autoclavable at 125°C for 30 minutes, 25 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 | ||
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 | ||
pH Compatibility | Compatible with pH range of 1-10 |
AseptiPrime® KS (25mm)
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Example:
IKX7 | 06 | 01 | M | N | X | X | 1 | 04 |
AseptiPrime® KS (50mm)
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Example:
VKX7 | 10 | 01 | SS | X | X | 1 | 04 |