0.45µm AseptiCap® KL/KS-γ Inline
mdi produces a wide range of Sterilizing grade PES membrane devices to meet filtration requirements of biopharmaceutical processing. These filter devices are validated to meet compendia and regulatory requirements and are well characterized. They meet key process requirements such as high retention efficiency, very high protein recoveries, extremely low extractables, high throughputs, wide chemical compatibility and other important characteristics.
With the advantages of pre-filtration layer built into the device for higher throughputs, linear scalability of filter area for smooth transitions from lab scale to pilot to process scale and widest range of end connections for quick and reliable connections to the existing fittings,mdi AseptiCap KL/KS filters are a universal solution for process filtration.
- 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
Bioburden Reduction/ Particulate Removal
- Buffers
- Centrifuge supernatants
- Clarified cell lysates
| Construction | |||
| Membrane | 0.45μm Hydrophilic PES | ||
| Upstream Membrane | 0.8 μm or 0.65 μm Hydrophilic PES | ||
| Plastic Parts | Gamma Stable Polypropylene | ||
| Size | |||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) – Female Luer Lock Inlet/ Male Luer Slip |
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| Dimension (End to End) – ¼” SHB |
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| Dimension (End to End) – ¾” Sanitary Flange Inlet I/O |
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| Operational Radius (with Vent/ Drain) |
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| Integrity Testing / Retention | |||
| Bubble Point | > 30psi (2.11Kg/cm²) with Water | ||
| Microbial Retention | LRV> 7 for Serratia marcescens (ATCC 14756) per cm² of filter area | ||
| Operational | |||
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| Hold-up Volume(with air purge) |
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| pH Compatibility | Compatible with pH range of 1-10 | ||
| Sterilization By Irradiation | Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized. | ||
| Shelf Life | 2 years after gamma 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> | ||
| 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 NVR test as per USP <661> | ||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices. | ||
| Oxidizable Substances | Within limits as specified in USP <1231> | ||
| Particle Shedding | Passes USP test for particulates in injectables. | ||
| TOC/Conductivity at 25 °C | Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 500ml flush | ||
| Quality Management System | ISO-9001 Certified | ||
| USFDA | DMF No. 015554 | ||
0.45µm AseptiCap® KL/KS -γ (25mm)
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a: Gamma irradiated filters can not be gamma sterilized again
*Female Luer Lock is available as Inlet only
**Male Luer Slip is available as Outlet only
Example:
| IKS5 | 06 | 02 | MN | R | X | 1 | 04 |
0.45µm AseptiCap® KL/KS- γ (50 mm)
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a: Gamma irradiated filters can not be gamma sterlized again
*¼” Stepped Hose Barb and ¾” Sanitary Flange are available in filters with vent only
**¼” Single Step Hose Barb and Female luer lock is available in filters without vent only
Example:
| VKS5 | 10 | 02 | BB | R | X | 1 | 02 |
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