0.1μm AseptiPrime® KS Inline
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 tosuit 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
- Very low hold up volume in filters
- High flow rates
- Serial construction with prefilter for higher throughput with fouling streams
- 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 EO gas or autoclaving
- Sterile Filtration of:
- Cell culture media
- Cell culture media containing serum
- Media additives
- pH adjusters
- Final product concentrates
Bioburden Reduction/ Particulate Removal:
- Buffers
- Centrifuge supernatants
- Clarified cell lysates
| Construction | |||
| Membrane | 0.1μm Hydrophilic PES | ||
| Final Filter Pore Size | 0.1 μm | ||
| Prefilter Pore Size | 0.3μm or 0.5μm | ||
| 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 | > 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 | |||
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| 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 as per USP <85> | ||
| 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> | ||
| Indirect Food Additive | Comply with USFDA 21 CFR Part 177.1520 | ||
| Extractables with WFI | Passes NVR test as per USP <661> | ||
| Oxidizable Substances | Within limits as specified in USP <1231> | ||
| 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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*Female Luer Lock is available as Inlet only
**Male Luer Slip is available as Outlet only
Example:
| IKX7 | 06 | 36 | M | N | X | X | 1 | 04 |
Example for Non Sterile: IKX70636MNXX104 Example for EO Sterile: IKX70636MNXX204
AseptiPrime® KS (50mm)
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Example:
| VKX7 | 10 | 36 | BB | X | X | 1 | 02 |
Example for Non Sterile: VKX71036BBXX104 Example for EO Sterile: VKX71036BBXX204
| File Type | Download |
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| Datasheet | Download |
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