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AseptiCap® NL/NS Inline
MDI AseptiCap NL/NS Nylon 66 membrane 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
- Absolute retention
- 100% integrity tested
- Very low hold up volume in filters
- High flow rates
- Serial construction with prefilter for higher throughput with fouling streams
- 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 from a few ml to thousands of liters
- Total traceability through unique serial number for each filter
- Individual certificate of quality for each device
- Sterilizable by EO gas or autoclaving
- 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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| Body and Core | Polypropylene | ||
| Prefilter Pore Size (In case of AseptiCap NS) |
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| Integrity Testing / Retention | |||
| Bubble Point (with 50% IPA) |
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| Size | |||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) – ¾” Sanitary Flange Inlet I/O |
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| Dimension (End to End) – ¼” SHB |
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| Dimension (End to End) – Female Luer Lock Inlet/ Male Luer Slip Outlet |
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| Operational Radius (with Vent/ Drain) |
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| Operational | |||
| Max. Operating Temperature |
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| Max. Differential Pressure |
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| Sterilization By Gas | Sterilizable by Ethylene Oxide | ||
| Sterilization By Autoclave | Autoclavable at 125°C for 30minutes 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 as per USP <85> | ||
| Bioburden | Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 : 2018 | ||
| Microbial Retention |
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| 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 NVR test as per USP <661> | ||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices. | ||
| Oxidizable Substances | Passes test as per USP <1231> | ||
| Particle Shedding | Passes USP test for particulates in injectables. | ||
| TOC/Conductivity at 25 °C | Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 500ml flush | ||
| Quality Management System | ISO-9001 Certified | ||
| USFDA | DMF No. 015554 | ||
AseptiCap NL/NS- (25 mm)
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*0.45μm Upstream is only available in 0.2μm Pore Size
**Female Luer Lock is available as Inlet only
***Male Luer Slip is available as Outlet only
Example :
| INSX | 06 | 01 | MN | X | X | 1 | 04 |
Example for Non Sterile: INSX0601MNXX104 Example for EO Sterile: INSX0601MNXX204
AseptiCap NL/NS- (50 mm)
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*0.45μm Upstream is only available in 0.2μm Pore Size
**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 :
| VNSX | 10 | 01 | SS | X | X | 1 | 02 |
Example for Non Sterile: VNSX1001SSXX102 Example for EO Sterile: VNSX1001SSXX202
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