AseptiCap® NL/NS Large
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
| 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 | ||||
| Size | |||||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) – ¾” Sanitary Flange I/O |
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| Dimension (End to End) – 1½” Sanitary Flange I/O |
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| Dimensions (End to End) Inline Capsule Filters – 1½” Sanitary Flange Inlet ½” Single Step Hose Barb Outlet |
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| Dimensions (End to End) Inline Capsule Filters – ½” Single Step Hose Barb I/O |
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| Dimension (End to End) – 1″ Hose Barb I/O |
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| Operational Radius (with Vent/ Drain) |
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| Dimension (End to End) – 3/8″ Hose Barb I/O |
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| Vent and Drain | ¼” Hose Barb with Silicone “O” rings | ||||
| Integrity Testing / Retention | |||||
| Microbial Retention |
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| Air Diffusion Flow per 10″ Capsule filter (with 50% IPA Wetted) |
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| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 2 Kg/cm² (30 psi) | ||||
| Max. Differential Pressure | < 4 Kg/cm² (60 psi ) @ 30 °C | ||||
| Sterilization By Gas | Sterilizable by Ethylene Oxide | ||||
| Sterilization By Autoclave | Autoclavable at 125 °C for 30 minutes 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 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 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 3 liter of WFI 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
**T-line is not available in 5″ Capsule filter
**T-line Capsule Filters are available with 1½” Sanitary Flange I/O Connections only
*** 3/8″ Hose Barb is available only with Inline capsule filters
**** 3/4″ Sanitary Flange end connection is available only in 5″ and 10″ capsule filters
Example :
| LNS5 | 54 | 01 | EE | X | X | 1 | 01 |
Example for Non Sterile: LNS55401EEXX101 Example for EO Sterile: LNS55401EEXX201
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