VWSX1001BSXX102 IWSX0601MNXX104 IWSX0601MNXX204VWSX1001BBXX102 IWSX0601MBXX104 IWSX0601MBXX204 IWSX0601MMXX104 IWSX0601MMXX204IWSX1001BSXX102 IWSX0601MHXX104 IWSX0601MHXX204IWSX1001BBXX102 IWSX0601BNXX104 IWSX0601BNXX204 IWSX0601BBXX104 IWSX0601BBXX204VWSX1001BSXX202 IWSX0601BMXX104 IWSX0601BMXX204VWSX1001BBXX202 IWSX0601BHXX104 IWSX0601BHXX204 IWSX1001BSXX202 IWSX0601HNXX104 IWSX0601HNXX204IWSX1001BBXX202 IWSX0601HBXX104 IWSX0601HBXX204 IWSX0601HMXX104 IWSX0601HMXX204 IWSX0601HHXX104 IWSX0601HHXX204 IWSX0601HNXX104 IWSX0601HNXX204 IWSX0601HBXX104 IWSX0601HBXX204 IWSX0601HMXX104 IWSX0601HMXX204 IWSX0601HHXX104 IWSX0601HHXX204 capsule filters, filters
- Absolute retention
- 100% integrity tested
- Low protein binding
- Low extractables
- Very low hold up volume
Sterile Filtration of:
- Antibodies
- Protein Solutions
- Buffers
- Heat labile additives
- Vaccine concentrates
- Small Volume Parenterals
Construction |
Membrane |
0.2 µm Hydrophilic PVDF |
Prefilter Membrane |
0.45 µm Hydrophilic PVDF |
Plastic parts |
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 |
> 50psi (3.52 Kg/cm²) with Water |
Microbial Retention |
LRV>7 for Brevundimonas diminuta (ATCC 19146) per cm² |
Operational |
Max. Operating Temperature |
|
Max. Differential Pressure |
75 Psi (5 Kg/cm²)@ 25 °C | 42 Psi (3 Kg/cm²) @ 30 °C |
|
Sterilization By Gas |
Sterilization by Ethylene Oxide |
Sterilization By Autoclave |
Autoclavable at 125°C for 30 minutes, 2 cycles 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 |
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 |
AseptiCap® WL/WS (25mm)
Type | IWL (Single Layer) | IWLX | IWS (0.8 μm Upstream) | IWS5 | IWS (0.45 μm Upstream) | IWSX | | | Pore Size | Pore Size | Code | 0.2µm | 01
| | Inlet/Outlet | Connection | Code | ⅛" Hose Barb
| H
| ¼" Hose Barb | B | Female Luer Slip | M | Male Luer lock | N | | | | Sterility | | Code | Non Sterile | 1 | EO Sterile | 2
| | Pack Size | Pack Size | Code | 100 | 04 | |
Example:
Example for Non Sterile: IWSX0601MNXX104 Example for EO Sterile: IWSX0601MNXX204
AseptiCap® Wl/WS (50mm)
Type | IWL(without Vent) (Single Layer) | IWLX | IWS (without Vent) (0.8 μm Upstream) | IWS5 | IWS (without Vent) (0.45 μm Upstream | IWSX | VWL (with Vent) (Single Layer) | VWLX | VWS (with Vent) (0.8 μm Upstream) | VWS5 | VWS (with Vent) (0.45 μm Upstream | VWSX | | | Pore Size | Pore Size | Code | 0.2µm | 01
| | Inlet/Outlet | 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 | 100 | 04 | |
Example:
*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 for Non Sterile: VWSX1001SSXX104 Example for EO Sterile: VWSX1001SSXX204