AseptiSure® NS Mini
MDI Aseptisure® NS Nylon 66 membrane mini cartridge filters are sterilizing grade filters offering absolute retention and wide chemical compatibility. These filters offer serial filtration for enhanced throughput. The upstream layer is of larger pore size to protect the downstream final filtration layer.
- Absolute Retention
- Wide Chemical Compatibility
- 100% Integrity Tested
| Consistent and Reliable Quality: | AseptiSure® cartridge filters are produced with ISO 9001-2008 certified quality management systems. |
| Regulatory Compliance: | Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554 |
| Low Protein Binding: | Results in increased overall product yield and higher throughputs with biological streams |
| High Throughputs: | Translates to lower filtration costs, less number of filter changes and overall economy of operations. |
| Total Traceability | Unique identification number is laser etched on each other. |
- Sterilization of compatible solvents and chemicals
- Sterilization of disinfecants in pharmaceutical labs and process areas
- Filtration of hospital disinfectants
- Filtration of rinse water for endoscopes and other hospital equipments
- Sterilizing filtration of pharmaceutical, aqueous and nonaqueous solutions
| Construction | |||
| Membrane | Nylon 66 | ||
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| Support Layers | Polyester | ||
| Body and Core | Polypropylene | ||
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| Microbial Retention |
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| Operational | |||
| Max. Operating Temperature | 80 °C @ < 2 Kg/cm² (30 psi) | ||
| Max. Differential Pressure | < 3.5Kg/cm² (50 psi) @ 25°C | ||
| Reverse Pressure | < 0.7 Kg/cm² (10 psi) @ 25 °C | ||
| Sterilization | Autoclavable/In-line Steam Sterilizable at 121°C for 30 minutes @ Δp= 5psi (0.3kg/cm²) | ||
| 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 ISO 11737-1 : 2018 | ||
| Non Fiber Releasing | Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release | ||
| 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 | ||
| 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 | ||
| Quality Management System | ISO-9001 Certified | ||
| USFDA | DMF No. 015554 | ||
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*0.45µm cartridge filter are available with 0.8µm upstream layer only
**G0 adapter code is not available with any elastomer. Pleasemention XX in place of elastomer code while ordering
***Adapter code F0 is available only in 5” cartridge filters
Example :
| CPNX | 50 | 01 | E0 | SS | 1 | 01 |
Example for Non Sterile: CPNX5001E0SS101
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