Catalogue No |
LSCPF70 |
CONSTRUCTION |
Membrane |
Positively Charged Nylon 66 |
Final Filter Pore Size |
0.2µm |
Prefilter Pore Size |
|
Support Layers |
Polyester |
Body and Core |
Polypropylene |
Integrity Testing / Retention |
Microbial Retention |
LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² |
Bubble Point (with 50% IPA) |
> 17psi (1.19Kg/cm²) |
Size |
Size |
|
Effective Filtration Area (Nominal) |
200cm² |
700cm² |
1400cm² |
2100cm² |
|
Dimension (End to End) - 1½" Sanitary Flange I/O |
91 mm |
110 mm |
161 mm |
211 mm |
|
Dimension (End to End) - ½" Single Step Hose Barb I/O |
|
OPERATIONAL |
Max. Operating Temperature |
80 °C @ < 30 psi (2 Kg/cm²) |
Max. Differential Pressure |
< 60 psi (4 Kg/cm²) @ 30 °C |
Sterilization By Gas |
Sterilizable by Ethylene Oxide |
Sterilization - By Autoclave |
Autoclavable at 125 °C for 30 minutes, 1 cycles and it cannot be steam sterilized. |
ASSURANCE |
Toxicity |
Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics |
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 |
Particle Release |
The filtrate complies with USP <788> test for particulate matter in injections |
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 |
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 |