0.2µm AseptiCap® WL/WS Small
MDI AseptiCap® WS 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
- Low extractables
- Very low hold up volume
Sterile Filtration of:
- Antibodies
- Protein Solutions
- Buffers
- Heat labile additives
- Vaccine concentrates
- Small Volume Parenterals
| Construction | |||||
| Membrane | Hydrophilic PVDF | ||||
| Final Filter Pore Size | 0.45 μm | ||||
| Prefilter Pore Size | 0.45μm, 0.8μm | ||||
| Plastic parts | Polypropylene | ||||
| Size | |||||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimensions (End to End) – 1½” Sanitary Flange I/O |
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| Dimension (End to End) – ½” Hose Barb I/O |
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| Dimension (End to End) – 1½” Sanitary Flange Inlet ½” Single Step Hose Barb Outlet |
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| Dimension (End to End) – ¼” SHB I/O |
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| Dimensions (End to End) – ¾” Sanitary Flange I/O |
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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 |
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| Integrity Testing / Retention | |||||
| Bubble Point | > 50psi (3.51Kg/cm²) with Water | ||||
| Microbial Retention |
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| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||||
| Max. Differential Pressure | 60 psi (4 Kg/cm²) @ 30 °C | ||||
| Sterilization By Gas | Sterilization by Ethylene Oxide | ||||
| Sterilization By Autoclave | Autoclavable at 125°C for 30 minutes, 2 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 | ||||
| TOC and Conductivity | Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a specified minimal flush | ||||
| Indirect Food Additive | Comply with USFDA 21 CFR Part 177.1520 | ||||
| Extractables with WFI | Passes test as per USP | ||||
| Oxidizable Substances | Within limits as specified in USP | ||||
| Particle Shedding | Passes USP test for particulates in injectables | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*0.45μm capsule filters are available with 0.8 μm upstream only
**1” Capsule Filters are not available with ½” Single step Hose Barb and 3/8″ Hose Barb
***Male luer slip is available only in 1” capsule filter as outlet
****3/16″ Hose Barb end connection is available in:
- 1″ and 2″ capsule filters as inlet and outlet
- 5″ capsule filters as outlet only
Example:
| DWSX | 53 | 01 | EE | X | X | 1 | 01 |
Example for Non Sterile: DWSX5301EEXX101 Example for EO Sterile: DWSX5301EEXX201
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