0.2µm AseptiCap® WL/WS-γ Large
MDI AseptiCap® WS-γ are low protein binding hydrophilic PVDF gamma sterilizable membrane capsule filters, designed for sterile filtration of very small fluid volumes in formulation and process development labs.
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 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
- Wide 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 Gamma irradiation
Sterile Filtration of:
- Antibodies
- Protein Solutions
- Buffers
- Heat labile additives
- 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 | ||||
| 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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a: 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
***T-line and 1″ Hose Barb is not available in 5″ capsule filters
Example:
| LWSX | 56 | 01 | R | X | 1 | 01 |
Example for Non Sterile: LWSX5601QQRX101 Example for Gamma Sterile: LWSX5601QQXX 301
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