IWSX0636MNXX104 IWS10636MNXX104 IWSX0636MNRX104 IWS10636MNRX104IWSX0636HHXX104 IWS10636HHXX104 IWSX0636HHRX104 IWS10636HHRX104IWSX0636BBXX104 IWS10636BBXX104 IWSX0636BBRX104 IWS10636BBRX104IWSX0636MNXX304 IWS10636MNXX304 IWSX0636HHXX304 IWS10636HHXX304 IWSX0636MLXX104 IWS10636MLXX104IWSX0636BBXX304 IWS10636BBXX304 IWSX0636MLXX304 IWS10636MLXX304VWSX1036BSXX102 VWS11036BSXX102 VWSX1036BSRX102 VWS11036BSRX102VWSX1036BBXX102 VWS11036BBXX102 VWSX1036BBRX102 VWS11036BBRX102VWSX1036BSXX302 VWS11036BSXX302 VWSX1036BBXX302 VWS11036BBXX302 Capsule filters, filters, asepticap
- Absolute retention
- 100% integrity tested
- Low protein binding
- Low extractables
- Very low hold up volume
Sterile Filtration of:
- Cell culture media
- Growth Regulators
- Small Volume Parenterals
Construction |
Membrane |
Hydrophilic PVDF |
Prefilter Membrane |
0.2 µm or 0.45 µm Hydrophilic PVDF |
Plastic parts |
Gamma Stable Polypropylene |
Size |
Size |
|
Effective Filtration Area (Nominal) |
|
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip |
|
Dimension (End to End) - ¼" SHB |
|
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O |
|
Operational Radius (with Vent/ Drain) |
|
Integrity Testing / Retention |
Bubble Point |
> 28 psi (1.96 Kg/cm²) with 50% IPA > 70 psi (4.92 Kg/cm²) with Water
|
Bacterial Retention |
LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area |
Operational |
Max. Operating Temperature |
|
Max. Differential Pressure |
75 Psi (5 Kg/cm²)@ 25 °C | 42 Psi (3 Kg/cm²) @ 30 °C |
|
Sterilization By Irradiation |
Gamma Irradiatiable up to 50 kGy |
Shelf Life |
2 years after gamma sterilization |
Assurance |
Toxicity |
Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics |
Cytotoxicity |
Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity |
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 |
TOC and Conductivity |
Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a specified minimal flush |
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 |
Oxidizable Substances |
Within limits as specified in USP |
Particle Shedding |
Passes USP test for particulates in injectables. |
Quality Management System |
ISO-9001 Certified |
USFDA |
DMF No. 015554 |
0.1µm AseptiCap® WL/WS-γ (25mm)
Type | IWL (Single Layer) | IWLX | IWS (0.2 μm Upstream) | IWS1 | IWS (0.45 μm Upstream) | IWSX | | | Pore Size | Pore Size | Code | 0.1µm | 36 | | Inlet/Outlet | Connection | Code | ⅛" Hose Barb
| H
| ¼" Hose Barb | B | Male Luer Slip | N | Male Luer lock | N | | Radiation Sterilizable | | Code | Yes | R | No | X | | | Sterility | | Code | Non Sterile | 1 | Gamma Sterile | 3 | | Pack Size | Pack Size | Code | 100 | 04 | |
* Gamma sterilized filters cannot be gamma irradiated again
Example:
Example for Non Sterile: IWSX0636MNRX104 Example for Gamma Sterile: IWSX0636MNXX304
0.1µm AseptiCap® WL/WS-γ (50mm)
Type | IWL (without Vent) (Single Layer) | IWLX | IWS (without Vent) (0.2 μm Upstream | IWS1 | IWS (without Vent) (0.45 μm Upstream) | IWSX | VWL (with Vent) (Single Layer) | VWLX | VWS (with Vent) (0.2 μm Upstream | VWS1 | VWS (with Vent) (0.45 μm Upstream | VWSX | | | Pore Size | Pore Size | Code | 0.1µm | 36 | | Inlet/Outlet | Connection | Code | ¼" Stepped Hose Barb | B** | ¾" Sanitary Flange | S** | Female Luer Lock | M*** | | Radiation Sterilizable | | Code | Yes | R | No* | X | | | Sterility | | Code | Non Sterile | 1 | Gamma Sterile | 3 | | Pack Size | Pack Size | Code | 10 | 02 | 100 | 04 | |
*Gamma sterilized filters cannot be gamma irradiated again
**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: VWSX1036SSRX104 Example for Gamma Sterile: VWSX1036SSXX304