0.2μm AseptiCap® KL/KS 25mm, 50mm
mdi AseptiCap® KL/KS are disposable PES membrane capsule filters offering a convenient lab scale solutions for process development with identical materials of construction for easy scale up to pilot scale and finally production scale filters.
| Consistent and Reliable Quality: |
AseptiCap® capsule filters are produced with ISO 9001 certified quality management systems. |
| Regulatory Compliance: |
Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554 |
| Low Protein Binding: |
Results in increased overall product yield |
| High Throughputs: |
Translates to lower filtration costs, less number o f filter changes and overall economy of operations. |
| Low Extractables: |
Mean less addition to impurity profile of the biological product from the filters. |
- Bioburden reduction from cell harvest supernatants
- Filtration of equilibrating, washing and elution buffers for chromatography columns
- Sterilization of biopharmaceuticals such as vaccines and therapeutic proteins
- Sterilization of buffers
- Sterilization of adjuvants
| Construction | |||
| Membrane | Hydrophilic PES | ||
| Final Filter Pore Size | 0.2µm | ||
| Prefilter Pore Size | 0.8 µm, 0.65µm, 0.45µm | ||
| Body and Core | 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) - ¾" Sanitary Flange Inlet I/O |
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| Dimension (End to End) - ¼" SHB |
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| Operational Radius (with Vent/ Drain) |
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| Integrity Testing / Retention | |||
| Bubble Point | > 50psi (3.52Kg/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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| Burst Pressure |
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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 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 | ||
| 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 for TOC <643> and Conductivity <645> after a 500ml flush Integrity Testing/ Retention Size Assurance Operational DST | ||
| Quality Management System | ISO-9001 Certified | ||
| USFDA | DMF No. 015554 | ||
0.2µm AseptiCap® KL/KS (25 mm)
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* 0.45µm upstream is available with 0.2µm pore size only
Example :
| IKSX | 06 | 01 | MN | X | X | 1 | 04 |
0.2µm AseptiCap® KL/KS (50 mm)
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* 0.45µm upstream is available with 0.2µm pore size only
**¼" Stepped Hose Barb and ¾" Sanitary Flange are available in filters with vent only
***Female luer lock is available in filters without vent only
Example :
| VKSX | 10 | 01 | SS | X | X | 1 | 02 |
