Catalogue No |
LSCPF38 |
CONSTRUCTION |
Membrane |
Hydrophilic PES |
Pore size |
0.1µm, 0.2µm, 0.5µm |
Prefilter Membrane |
Microglassfiber |
Support Layers |
Polyester |
Body and Core |
Polypropylene |
Size |
Size |
|
Effective Filtration Area (Nominal) |
2500 cm² |
5000 cm² |
10000 cm² |
15000 cm² |
|
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet |
203 mm |
332 mm |
607 mm |
882 mm |
|
Dimension (End to End) - 1½" Sanitary Flange I/O |
207 mm |
326 mm |
601 mm |
876 mm |
|
Dimension (End to End) - ½" Single Step Hose Barb I/O |
217 mm |
332 mm |
607 mm |
882 mm |
|
Operational Radius (with Vent/ Drain) |
|
Vent and Drain |
¼" Hose Barb with Silicone "O" ring |
OPERATIONAL |
Max. Operating Temperature |
80 °C @ < 30 psi (2 Kg/cm²) |
Max. Differential Pressure |
< 60 psi (4 Kg/cm²) @ 30 °C |
Sterilization - By Autoclave |
Autoclavable at 125°C for 30 minutes, 1 cycle after gamma irradiationa and it cannot be in-line steam sterilized |
Sterilization - By Irradiation |
Gamma Irradiatable up to 50 kGy |
Shelf Life |
2 years after gamma sterilization |
ASSURANCE |
Toxicity |
Passes Bioreactivity test, In Vivo, as per USP 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 |
Quality Management System |
ISO-9001:2008 Certified |
USFDA |
DMF No. 015554 |