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
| 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 |
|
||
| Support Layers | Polyester | ||
| Body and Core | Polypropylene | ||
| Prefilter Pore Size (In case of AseptiCap NS) |
|
||
| Size | |||
| Size |
|
||
| Effective Filtration Area (Nominal) |
|
||
| Dimension (End to End) – ¾” Sanitary Flange Inlet I/O |
|
||
| Dimension (End to End) – ¼” SHB |
|
||
| Dimension (End to End) – Female Luer Lock Inlet/ Male Luer Slip Outlet |
|
||
| Operational Radius (with Vent/ Drain) |
|
||
| Integrity Testing / Retention | |||
| Bubble Point (with 50% IPA) |
|
||
| Operational | |||
| Max. Operating Temperature |
|
||
| Max. Differential Pressure |
|
||
| Burst Pressure |
|
||
| Hold-up Volume(with air purge) |
|
||
| 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 | ||
| Bioburden | Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 : 2018 | ||
| Microbial Retention |
|
||
| 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 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)
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
*0.45μm Upstream is only available in 0.2μm Pore Size
Example :
| INSX | 06 | 01 | MN | X | X | 1 | 04 |
Example for Non Sterile: INSX0601MNXX104 Example for EO Sterile: INSX0601MNXX204
AseptiCap NL/NS- (50 mm)
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
*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
Have questions or need assistance?
Our team is here to help! Contact us today, and we’ll get back to you as soon as possible.