0.2µm AseptiCap® WL/WS Large
MDI AseptiCap® WS are low protein binding hydrophilic PVDF gamma sterilizable membrane inline 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 | ||||
| Pore size | 0.2 μm | ||||
| Prefilter Pore Size | 0.45μm, 0.8μm | ||||
| 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) – ¾” Sanitary Flange I/O |
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| Dimension (End to End) – ½” Single Step Hose Barb I/O |
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| Dimension (End to End) – 1″ Hose Barb I/O |
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| Operational Radius (with Vent/ Drain) |
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| Dimension (End to End) – 3/8″ Hose Barb I/O |
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| Vent and Drain | ¼” Hose Barb with Silicone “O” ring | ||||
| Integrity Testing / Retention | |||||
| Microbial Retention |
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| Bubble Point (with 50% IPA) | >31psi (2.18 Kg/cm²) with 50% IPA/ water solution | ||||
| Operational | |||||
| Max. Operating Temperature | 80°C @ < 2Kg/cm² (30 psi) | ||||
| Max. Differential Pressure | < 4 Kg/cm² (60 psi) @ 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 | ||||
| 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 | ||||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices | ||||
| Oxidizable Substances | Within limits as specified in USP | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*0.45 μm capsule filters are available with 0.8 μm upstream only
** 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 | 54 | 01 | X | X | 1 | 01 |
Example for Non Sterile: LWSX5401QQXX101 Example for EO Sterile: LWSX5401QQXX201
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