| Construction |
| Final Filter Pore Size |
0.1 μm |
Prefilter Membrane
(in case of AseptiCap KS) |
0.45 μm |
| Membrane |
Hydrophilic PES |
| Support Layers |
Polyester |
| Body and Core |
Polypropylene |
| Integrity Testing / Retention |
| Bubble Point |
> 31psi (2.18Kg/cm²)
with 50% IPA/Water Solution |
| Microbial Retention |
LRV >7 for Acholeplasma laidlawii
(ATCC 23206) per cm² |
| Size |
| Size |
25 mm |
50 mm |
| Effective Filtration Area (Nominal) |
5 cm² |
20 cm² |
Dimension
(End to End) |
¼" SHB |
-- |
64.7 mm |
| ¾" Sanitary Flange Inlet I/O |
-- |
51.4 mm |
| Female Luer Lock Inlet/ Male Luer Slip Out let |
23 mm |
-- |
| Operational Radius (with Vent/ Drain) |
15 mm |
28 mm |
Operational |
| Max. Operating Temperature |
55 °C |
60 °C |
| Max. Differential Pressure |
75 Psi (5 Kg/cm²)@ 25 °C |
42 Psi (3 Kg/cm²) @ 30 °C |
| Hold-up Volume(with air purge) |
<50 µL |
<30O µL |
| Burst Pressure |
> 14 Kg/cm² |
> 8 Kg/cm² |
| Sterilization |
By Irradiation |
AseptiCap KL/KS- γ: Gamma Irradiatiable up to 50 kGy |
| By Gas |
Sterilizable by Ethylene Oxide |
| By Autoclave |
Autoclavable at 121°C for 30minutes, 1 cycle after gamma irradiation. Can not be in-line steam sterilized |
| Shelf Life |
2 years after gamma sterilization |
| pH Compatibility |
Compatible with pH range of 1-10 |
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 |
| Bioburden |
Bioburden level is < 1000 cfu/filter device as per ANSI/AAMI/ISO 11737-1 : 1995 |
| Bacterial Endotoxin |
Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test |
| Non Fiber Releasing |
Passes test as per USP and comply with USFDA 21 CFR Part 211.72 for fiber release |
| 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. |
| 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 |
| Indirect Food Additive |
All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 |
| Good Manufacturing Practice |
These products are manufactured in a facility which adheres to Good Manufacturing Practices. |
| Quality Management System |
ISO-9001:2008 Certified |
| ISO-13485 : 2003 for Medical Devices Only |
