0.2μm AseptiCap® WL/WS-γ 5", 10", 20", 30"
mdi AseptiCap® WL/WS-γ are low protein binding hydrophilic PVDF gamma sterilizable membrane capsule filters offering serial filtration incorporating a larger pore size upstream membrane to protect the downstream membrane for enhanced throughput.
These capsule filters are validated to meet compendia and regulatory requirements and are well characterized. They meet key process requirements such as absolute retention efficiency, extremely low extractables, high throughputs, wide chemical compatibility and other important characteristics.
- Absolute retention
- 100% integrity tested
- Low hold up volume
| 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 of filter changes and overall economy of operations. |
| Low Extractables: | Mean less addition to impurity profile of the biological product from the filters. |
Sterile Filtration of:
- Antibodies
- Protein Solutions
- Buffers
- Vaccine concentrates
- Small Volume Parenterals
| Construction | |||||
| Membrane | Hydrophilic PVDF | ||||
| Final Filter Pore Size | 0.2 µm | ||||
| Prefilter Pore Size | 0.8 µm or 0.45 µm Hydrophilic PVDF | ||||
| Support Layers | Polyester | ||||
| Plastic parts | Polypropylene | ||||
| Body and Core | Gamma Stable Polypropylene | ||||
| Size | |||||
| Size |
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| Effective Filtration Area |
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| Dimensions (End to End) - 1½" Sanitary Flange I/O |
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| Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet |
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| Dimension (End to End) - ½" Single Step Hose Barb I/O |
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| Operational Radius (with Vent/ Drain) |
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| Vent and Drain | ¼" Hose Barb with Silicone "O" ring | ||||
| Integrity Testing / Retention | |||||
| Bubble Point | > 50 psi (3.51 Kg/cm² ) with Water | ||||
| Microbial Retention | LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² | ||||
| Operational | |||||
| Max. Operating Temperature | 80°C @ < 2Kg/cm² (30 psi) | ||||
| Max. Differential Pressure | < 4 Kg/cm² (60 psi) @ 30° C | ||||
| Sterilization By Irradiation | Gamma Irradiatiable up to 50 kGy. These filters must 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 | ||||
| TOC and Conductivity | Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 10 liter flush for 5” capsule filters and 20 liter flush for 10” capsule filters. | ||||
| 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 NVR test as per USP <661> | ||||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices | ||||
| Oxidizable Substances | Passes test as per USP <1231> | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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* Gamma sterilized filters cannot be gamma irradiated again
** T-line Capsule Filters are available with 1½” Sanitary Flange I/O Connections Only
***3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filters
****1" Hose Barb is not available in 5" capsule filters
Example:
| LWSX | 56 | 01 | R | X | 1 | 01 |
