0.1µm AseptiCap® WL/WS-γ Inline
MDI AseptiCap® WS-γ 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:
- Cell culture media
- Growth Regulators
- Small Volume Parenterals
| Construction | |||
| Membrane | Hydrophilic PVDF | ||
| Prefilter Membrane | 0.2 µm or 0.45 µm Hydrophilic PVDF | ||
| Plastic parts | Gamma Stable Polypropylene | ||
| Size | |||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) – Female Luer Lock Inlet/ Male Luer Slip |
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| Dimension (End to End) – ¼” SHB |
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| Dimension (End to End) – ¾” Sanitary Flange Inlet I/O |
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| Operational Radius (with Vent/ Drain) |
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| 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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| Bacterial Retention | LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area | ||
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| Sterilization By Irradiation | Gamma Irradiatiable up to 50 kGy | ||
| 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 | ||
| 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 | All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 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 | ||
0.1µm AseptiCap® WL/WS-γ (25mm)
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* Gamma sterilized filters cannot be gamma irradiated again
**Female Luer Lock is available as Inlet only
***Male Luer Slip is available as Outlet only
Example:
| IWSX | 06 | 36 | M | N | X | X | 1 | 04 |
Example for Non Sterile: IWSX0636MNRX104 Example for Gamma Sterile: IWSX0636MNXX304
0.1µm AseptiCap® WL/WS-γ (50mm)
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*Gamma sterilized filters cannot be gamma irradiated again
**¼” Stepped Hose Barb and ¾” Sanitary Flange are available in filters with vent only
**¼” Single Step Hose Barb and Female luer lock is available in filters without vent only
Example:
| VWSX | 10 | 36 | SS | R | X | 1 | 04 |
Example for Non Sterile: VWSX1036SSRX104 Example for Gamma Sterile: VWSX1036SSXX304
| File Type | Download |
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| Datasheet | Download |
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