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