AseptiCap® Nano Large
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
| Construction | |||||
| Membrane | Hydrophilic PES | ||||
| Plastic parts | Polypropylene | ||||
| Size | |||||
| Size |
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| Effective Filtration Area |
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| Operational Radius (with Vent/ Drain) |
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| Vent and Drain | ¼” Hose Barb with Silicone “O” rings | ||||
| Integrity Testing / Retention | |||||
| Air Diffusion Flows @20 psi |
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| 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 30minutes. Can not be in-line steam sterilized | ||||
| Assurance | |||||
| 100% Integrity Tested |
Each AseptiCap® Nano is tested for integrity to comply with validated Acceptable Integrity Test Specifications.
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| 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>
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| Bioburden | Device bioburden is tested as per ISO 117 37-1 and assured to be <1000 cfu/device. | ||||
| 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 10 liter flush for 5” capsule filters and 20 liter flush for 10” capsule filters | ||||
| 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 | ||||
| Package Integrity | AseptiCap® Nano capsule filters are fitted with vent caps and are packed in bags to ensure package integrity during transit as well as to prevent particulate contamination while transferring to clean room assembly or process areas. | ||||
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*T-line is not available in 5″ Capsule filter
*T-line Capsule filter are available with 1½” Sanitary Flange I/O connection only
***3/4″ Sanitary Flange end connection is available only in 5″ and 10″ capsule filters
Example :
| LKNX | 57 | S7 | EE | X | X | 1 | 01 |
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