AseptiSure® NS Standard
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
- Minimal extractables
- High heat resistance
- Wide chemical compatibility
- Biologically inert
- Long service life
- Non-toxic material of construction
- Pre-flushed to minimize particulate release after installation
- 100% integrity tested
- High flow rates
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Unique identification number is laser etched on each filter
- Individual certificate of quality for each device
- Sterilizable by Autoclaving/Steaming in place (SIP)
- 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
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| Membrane | Nylon 66 | ||||
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| Support Layers | Polyester | ||||
| Body and Core | Polypropylene | ||||
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| 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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*FV is available in Adapter Code A0 (7P) and A1 (7P without fin) only
**Size 5″ is available in Code A0 (7P) and A1 (7P without fin) only
***0.45µm Cartridge filters are available with 0.8µm upstream layer only.
Example :
| CPN5 | 55 | 01 | A0 | SV | 1 | 01 |
Example for Non Sterile: CPN55501A0SV101
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