0.2µm AseptiSure® WS Mini 2.5", 5"
mdi AseptiSure® WS are low protein binding hydrophilic PVDF membrane mini cartridge filters offering serial filtration incorporating a large pore size upstream membrane to protect the downstream membrane for enhanced throughput.
These cartridge 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
- Antibodies
- Protein Solutions
- Buffers
- Vaccine concentrates
- Small Volume Parenterals
Construction | |||
Membrane | Hydrophilic PVDF | ||
Final Filter Pore Size | 0.2µm | ||
Prefilter Pore Size | 0.45 µm | ||
Support Layers | Polyester | ||
Plastic parts | Polypropylene | ||
Body and Core | Polypropylene | ||
Size | |||
Size |
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Effective Filtration Area (Nominal) |
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Integrity Testing / Retention | |||
Bubble Point | > 50psi (3.51Kg/cm²) with Water | ||
Microbial Retention | LRV >7 for B. diminuta (ATCC 19146) per cm² | ||
Operational | |||
Max. Operating Temperature | 80 °C @ < 2 Kg/cm² (30 psi) | ||
Max. Differential Pressure | 3.5 Kg/cm² (50 psi) @ 25 °C | ||
Reverse Pressure | < 0.7 Kg/cm² (10 psi) @ 25 °C | ||
Typical Water Flow Rates (10" Cartridge filters) |
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Sterilization | Autoclavable/ Inline steam sterilizable at 135°C for 3 cycles of 30 minutes each |
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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 | ||
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 | ||
Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices. | ||
Oxidizable Substances | Within limits as specified in USP | ||
Particle Shedding | Passes USP test for particulates in injectables. | ||
TOC/Conductivity at 25 °C | Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush | ||
Quality Management System | ISO-9001 Certified | ||
USFDA | DMF No. 015554 |
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*G0 adapter code is not available with any elastomer. Please mention XX in place of elastomer code while ordering
**Adapter code F0 is available only in 5” cartridge filters
Example :
CWHX | 53 | 01 | E0 | SS | 1 | 01 |