0.1µm AseptiCap® WL/WS-γ Small
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:
- Cell culture media
- Growth Regulators
- Small Volume Parenterals
| Construction | |||||
| Membrane | Hydrophilic PVDF | ||||
| Final Filter Pore Size | 0.1µm | ||||
| Prefilter Pore Size | 0.2 µm or 0.45 µm | ||||
| Support Layer | Polyester | ||||
| Plastic parts | Gamma Stable 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 | ¼” Hose Barb with Silicone “O” rings | ||||
| Integrity Testing / Retention | |||||
| Bubble Point | > 28 psi (1.96 Kg/cm²) with 50% IPA
> 70 psi (4.92 Kg/cm²) with Water |
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| Microbial Retention | LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area | ||||
| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||||
| Max. Differential Pressure | 60 psi (4 Kg/cm²) @ 30 °C | ||||
| Sterilization By Irradiation | Gamma Irradiatiable up to 50 kGy. Gamma sterilized capsule 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 specified minimal flush | ||||
| Indirect Food Additive | Comply with USFDA 21 CFR Part 177.1520 | ||||
| Extractables with WFI | Passes NVR test as per USP <661> | ||||
| Oxidizable Substances | Passes test as per USP <1231> | ||||
| Particle Shedding | Passes USP test for particulates in injectables | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*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
a: Gamma sterile capsule filters cannot be gamma irradiated again
b: Bell and bell with cover is available with :
- ½” HB outlet connections in 1”, 2”, 5” and 8” capsule filters
- ¼” SHB outlet connection in 1” capsule filters only
Example:
| DWSX | 53 | 36 | R | X | 1 | 01 |
Example for Non Sterile: DWSX5336QQRX101 Example for Gamma Sterile: DWSX5336QQXX301
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