AseptiCap® Nano 25mm, 50mm, nano, asepticap nano, asepticap nano, special filters, inline nano filters, 25mm asepticap nano, 50mm asepticap nano, VKNX, IKNX
- Absolute retention
- 100% integrity tested
- Low hold up volume for minimal filtration losses
- Very low extractables
- High flow rates
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Widest range of end connections
- Products available for total scalability
- Total traceability through unique serial number for each filter
- Individual certificate of quality for each device
Sterilizing filtration of nano particles based drug products
Construction |
Membrane |
Hydrophilic PES |
Plastic parts |
Polypropylene |
Size |
Size |
|
Effective Filtration Area (Nominal) |
|
Operational Radius (with Vent/ Drain) |
|
Operational |
Max. Operating Temperature |
|
Max. Differential Pressure |
5 Kg/cm² (75 Psi) @ 25° C | 3 Kg/cm² (42 Psi) @ 30° C |
|
Sterilization By Autoclave |
Autoclavable at 125 °C for 30minutes. Can not be in-line steam sterilized |
Assurance |
Toxicity |
Passes Biological Reactivity Tests, 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 as per USP <85> |
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 500ml flush |
Indirect Food Additive |
Comply with USFDA 21 CFR Part 177.1520 |
Extractables with WFI |
Passes NVR test as per USP <661> |
Oxidizable Substances |
Within limits as specified in USP <1231> |
Quality Management System |
ISO-9001 Certified |
USFDA |
DMF No. 015554 |
AseptiCap® Nano (25 mm)
Type | AseptiCap® Nano
| IKNX | | | | I/O Connection | Connection | Code | Female Luer Lock | M | Male Luer Slip | N | ⅛" Hose Barb | H
| ¼" Hose Barb | B | | | | Sterility | | Code | Non Sterile | 1 | | Pack Size | Pack Size | Code | 100 | 04 | |
Example :
AseptiCap® Nano (50 mm)
Type | AseptiCap® Nano (with vent)
| VKNX | AseptiCap® Nano (without vent)
| IKNX | | | | I/O Connection | Connection | Code | ¼" Stepped Hose Barb | B* | ¾" Sanitary Flange | S* | Female Luer Lock | M** | | | | Sterility | | Code | Non Sterile | 1 | | Pack Size | Pack Size | Code | 12 | 08 | |
*¼" Stepped Hose Barb and ¾" Sanitary Flange are available in filters with vent only
**Female luer lock is available in filters without vent only
Example :