Catalogue No |
LSCPF52 |
CONSTRUCTION |
Membrane |
Hydrophilic PVDF |
Final Filter Pore Size |
|
Prefilter Pore Size |
0.45μm, 0.8μm |
Plastic parts |
Polypropylene |
Integrity Testing / Retention |
Bubble Point |
> 50psi (3.51Kg/cm²) with Water |
Microbial Retention |
LRV >7 for B. diminuta (ATCC 19146) per cm² |
LRV >7 for S. marcescens(ATCC 14756) per cm² |
|
Size |
Size |
|
Effective Filtration Area (Nominal) |
250cm² |
500cm² |
1000cm² |
2000cm² |
|
Dimensions (End to End) - 1½" Sanitary Flange I/O |
91 mm |
110 mm |
161 mm |
211 mm |
|
Dimension (End to End) - ½" Hose Barb I/O |
90 mm |
112 mm |
164 mm |
215 mm |
|
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet |
|
Dimension (End to End) - ¼" SHB I/O |
92 mm |
122 mm |
172 mm |
223 mm |
|
Dimensions (End to End) - ¾" Sanitary Flange I/O |
91 mm |
103 mm |
155 mm |
205 mm |
|
Dimension (End to End) - ½" Single Step Hose Barb I/O |
|
Operational Radius (with Vent/ Drain) |
|
Vent and Drain |
¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only |
|
OPERATIONAL |
Max. Operating Temperature |
80 °C @ < 30 psi (2 Kg/cm²) |
Max. Differential Pressure |
60 psi (4 Kg/cm²) @ 30 °C |
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 |
Comply with USFDA 21 CFR Part 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 |
pH Compatibility |
Compatible with pH range of 1 - 10 |