Details
0.1µm AseptiSure WS Mini 2.5", 5"
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.
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Absolute retention
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100% integrity tested
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Low protein binding
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Low extractables
Applications:
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Antibodies
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Protein Solutions
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Buffers
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Cell culture media
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Vaccine concentrates
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Small Volume Parenterals
Specifications:
Catalogue No |
LSCFL19 |
CONSTRUCTION |
Membrane |
Hydrophilic PVDF |
Final Filter Pore Size |
0.1µm |
Prefilter Pore Size |
0.2µm or 0.45 µm |
Support Layers |
Polyester |
Plastic parts |
Polypropylene |
Body and Core |
Polypropylene |
Integrity Testing / Retention |
Bubble Point |
> 31psi (2.18Kg/cm²) with 50% IPA/Water Solution |
Microbial Retention |
LRV >7 for A. laidlawii (ATCC 23206) per cm² |
Size |
Size |
|
Effective Filtration Area (Nominal) |
|
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 |
Sterilization |
Autoclavable/ Inline steam sterilizable at 135°C for 30 minutes, 2 cycles |
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 ANSI/AAMI/ISO 11737-1 : 1995 |
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-9001:2008 Certified |
USFDA |
DMF No. 015554 |
pH Compatibility |
Compatible with pH range of 1 - 10 |