Catalogue No |
LSCPF51 |
CONSTRUCTION |
Membrane |
0.2 µm Hydrophilic PVDF |
Prefilter Membrane |
0.45 µm Hydrophilic PVDF |
Plastic parts |
Polypropylene |
Integrity Testing / Retention |
Bubble Point |
> 50psi (3.52 Kg/cm²) with Water |
Microbial Retention |
LRV>7 for Brevundimonas diminuta (ATCC 19146) per cm² |
Size |
Size |
|
Effective Filtration Area (Nominal) |
|
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip |
|
Dimension (End to End) - ¼" SHB |
|
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O |
|
Operational Radius (with Vent/ Drain) |
|
OPERATIONAL |
Max. Operating Temperature |
|
Max. Differential Pressure |
75 Psi (5 Kg/cm²)@ 25 °C |
42 Psi (3 Kg/cm²) @ 30 °C |
|
pH Compatibility |
Compatible with pH range of 1-14 |
Sterilization By Gas |
Sterilization by Ethylene Oxide |
Sterilization - By Autoclave |
Autoclavable at 125°C for 30 minutes, 25 cycles and it cannot be in-line steam sterilized |
Shelf Life |
3 years after EO 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 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 |
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 |