AseptiCap NL/NS 1", 2", 5", 8"
mdi AseptiCap NL/NS Nylon 66 membranes capsule filters are sterilizing grade filters offering absolute retention, wide chemical compatibility, and very low hold up volumes.
- Single Layered: AseptiCap NL
- Multiple Layered: AseptiCap NS
| Consistent and Reliable Quality: |
AseptiCap capsule filters are produced with ISO 9001 certified quality management systems. |
| Regulatory Compliance: |
Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554 |
| Total traceability: |
Unique marking on each filter |
- Sterilizing filtration of stability batches in formulation development tabs
- Sterilization of Compatible solvents and chemicals
| Construction | |||||
| Membrane | Nylon 66 | ||||
| Final Filter Pore Size |
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| Support Layers | Polyester | ||||
| Body and Core | Polypropylene | ||||
| Prefilter Pore Size (In case of AseptiCap NS) |
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| Integrity Testing / Retention | |||||
| Microbial Retention |
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| Bubble Point (with 50% IPA) |
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| Size | |||||
| Size |
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| Effective Filtration Area (Nominal) - AseptiCap NL |
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| Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet |
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| Effective Filtration Area (Nominal) - AseptiCap NS |
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| Dimension (End to End) - ¾" Sanitary Flange Inlet I/O |
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| Dimension (End to End) - 1½" Sanitary Flange I/O |
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| Dimension (End to End) - ½" Hose Barb I/O |
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| Dimension (End to End) - ½" Single Step Hose Barb I/O |
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| Operational Radius (with Vent/ Drain) |
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| Vent and Drain |
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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 Gas | Sterilizable by Ethylene Oxide | ||||
| Sterilization By Autoclave | Autoclavable at 125 °C for 30 minutes 25cycles and it cannot be in-line steam sterilized. | ||||
| Shelf Life | 3 years after EO sterilization | ||||
| Assurance | |||||
| Toxicity | Passes Bioreactivity test, 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 | ||||
| Bioburden | Bioburden level is < 1000 cfu/filter device as per ANSI/AAMI/ISO 11737-1 : 1995 | ||||
| Non Fiber Releasing | Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(3) 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 NVR test as per USP <661> | ||||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices. | ||||
| Oxidizable Substances | Within limits as specified in USP <1231> | ||||
| 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 Upstream is only available in 0.2μm Pore Size
**1” Capsule Filters are not available with ½” Single step Hose Barb, ½" MNPT and 3/8" Hose Barb
***Female luer lock is available in 1” and 2” capsule filters only
****Male luer slip is available only in 1” capsule filter as outlet
*****Bell is available with:
- ½" Hose Barb outlet connections in 1", 2", 5" and 8" capsule filters
- ¼" SHB outlet connection in 1" capsule filters only
Example :
| DNS5 | 52 | 01 | DD | X | X | 1 | 01 |
