AseptiCap® Nano Inline
MDI AseptiCap® Nano Capsule filters are ready to use, disposable, highly retentive filtration devices specially designed for difficult to filter nano particles based drug formulations. These filters house specifically designed asymmetric PES membrane which allows high yield (> 90%) while assuring a sterile downstream.
- 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
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| Membrane | Hydrophilic PES | ||
| Plastic parts | Polypropylene | ||
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| Operational Radius (with Vent/ Drain) |
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| 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)
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Example :
| IKNX | 06 | S7 | MN | X | X | 1 | 04 |
AseptiCap® Nano (50 mm)
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*¼” Stepped Hose Barb and ¾” Sanitary Flange are available in filters with vent only
**¼” Single Step Hose Barb and Female luer lock is available in filters without vent only
Example :
| VKNX | 10 | S7 | BB | X | X | 1 | 08 |
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