Catalogue No |
LSCFL17 |
CONSTRUCTION |
Membrane |
Hydrophilic Polyethersulfone |
Final Filter Pore Size |
0.2 µm |
Prefilter Pore Size |
0.5µm |
Support Layers |
Polyester |
Body and Core |
Polypropylene |
Integrity Testing / Retention |
Bubble Point |
> 50psi (3.52 Kg/cm²) with Water |
Microbial Retention |
LRV >7 for B.diminuta (ATCC 19146) per cm² |
Size |
Size |
|
Effective Filtration Area (Nominal) |
|
OPERATIONAL |
Max. Operating Temperature |
80°C @ < 30 psi (2 Kg/cm²) |
Max. Differential Pressure |
50 psi (3.5 Kg/cm²) @ 25°C |
Reverse Pressure |
< 0.7 Kg/cm² (10 psi) @ 25 °C |
Sterilization |
In-line steam sterilizable at 135°C for 30 minutes at a maximum differential pressure of 3 psi (0.21 kg/cm²), 25 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 |