| INLX0601MLXX204 |
| INNX1001CCXX102 |
| INNX1001CCXX108 |
| INS51002MMXX102 |
| INSX1001MMXX201 |
| INSX1001MMXX202 |
| INSX1001MMXX208 |
| VNS51002MMXX102 |
| VNSX1001BBXX202 |
capsule filters, filters, nylon
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) |
| > 17psi (1.19Kg/cm²) | > 11psi (0.77Kg/cm²) |
|
| Operational |
| Max. Operating Temperature |
|
| Max. Differential Pressure |
| 5 Kg/cm² (75 Psi) @ 25° C | 3 Kg/cm² (42 Psi) @ 30° C |
|
| 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 |
| (LRV >7 for) Brevundimonas diminuta (ATCC 19146) per cm² | (LRV >7 for) Serratia marcescens (ATCC 14756) per cm² |
|
| 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)
| Type | | AseptiCap NL (Single Layer ) | INLX | | AseptiCap NS (0.45 μm* Upstream) | INSX | | AseptiCap NS ( 0.8 μm Upstream ) | INS5 | | | | Pore Size | | Pore Size | Code | | 0.2µm | 01 | | 0.45µm | 02 | | | I/O Connection | | Connection | Code | | Female Luer lock | M | | Male Luer Slip | N | | ⅛" Hose Barb | H
| | ¼" Hose Barb | B | | | | | Sterility | | Code | | Non Sterile | 1 | | EO Sterile | 2 | | | Pack Size | | Pack Size | Code | | 100 | 04 | |
*0.45μm Upstream is only available in 0.2μm Pore Size
Example :
Example for Non Sterile: INSX0601MNXX104 Example for EO Sterile: INSX0601MNXX204
AseptiCap NL/NS- (50 mm)
| Type | | AseptiCap NL (without vent) (Single Layer ) | INLX | | AseptiCap NS (without vent) (0.45 μm* Upstream) | INSX | | AseptiCap NS (without vent) ( 0.8 μm Upstream ) | INS5 | | AseptiCap NL (with vent) (Single Layer ) | VNLX | | AseptiCap NS (with vent) (0.45 μm* Upstream) | VNSX | | AseptiCap NS (with vent) ( 0.8 μm Upstream ) | VNS5 | | | | Pore Size | | Pore Size | Code | | 0.2µm | 01 | | 0.45µm | 02 | | | I/O Connection | | Connection | Code | | ¼" Stepped Hose Barb | B** | | ¾" Sanitary Flange | S** | | Female Luer Lock | M*** | | | | | Sterility | | Code | | Non Sterile | 1 | | EO Sterile | 2 | | | Pack Size | | Pack Size | Code | | 10 | 02 | |
*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
***Female luer lock is available in filters without vent only
Example :
Example for Non Sterile: VNSX1001SSXX102 Example for EO Sterile: VNSX1001SSXX202
