IKS70601MNXX104 IKS90601MNXX104IKS70601HHXX104 IKS90601HHXX104IKS70601BBXX104 IKS90601BBXX104IKS70601MNXX304 IKS90601MNXX304IKS70601HHXX304 IKS90601HHXX304IKS70601BBXX304 IKS90601BBXX304 VKS71001BSXX102 VKS91001BSXX102VKS71001BBXX102 VKS91001BBXX102 VKS71001BSXX302 VKS91001BSXX302VKS71001BBXX302 VKS91001BBXX302 IKS70601MNXX104 IKS90601MNXX104IKS70601MBXX104 IKS90601MBXX104IKS70601MMXX104 IKS90601MMXX104IKS70601MHXX104 IKS90601MHXX104 IKS70601BNXX104 IKS90601BNXX104IKS70601BBXX104 IKS90601BBXX104IKS70601BMXX104 IKS90601BMXX104IKS70601BHXX104 IKS90601BHXX104 IKS70601HNXX104 IKS90601HNXX104IKS70601HBXX104 IKS90601HBXX104IKS70601HMXX104 IKS90601HMXX104IKS70601HHXX104 IKS90601HHXX104 IKS70601MNXX304 IKS90601MNXX304IKS70601MBXX304 IKS90601MBXX304IKS70601MMXX304 IKS90601MMXX304IKS70601MHXX304 IKS90601MHXX304 IKS70601BNXX304 IKS90601BNXX304IKS70601BBXX304 IKS90601BBXX304IKS70601BMXX304 IKS90601BMXX304IKS70601BHXX304 IKS90601BHXX304 IKS70601HNXX304 IKS90601HNXX304IKS70601HBXX304 IKS90601HBXX304IKS70601HMXX304 IKS90601HMXX304IKS70601HHXX304 IKS90601HHXX304 IKS70601MNRX104 IKS90601MNRX104IKS70601HHRX104 IKS90601HHRX104IKS70601BBRX104 IKS90601BBRX104 IKS70601MNRX104 IKS90601MNRX104IKS70601MBRX104 IKS90601MBRX104IKS70601MMRX104 IKS90601MMRX104IKS70601MHRX104 IKS90601MHRX104 IKS70601BNRX104 IKS90601BNRX104IKS70601BBRX104 IKS90601BBRX104IKS70601BMRX104 IKS90601BMRX104IKS70601BHRX104 IKS90601BHRX104 IKS70601HNRX104 IKS90601HNRX104IKS70601HBRX104 IKS90601HBRX104IKS70601HMRX104 IKS90601HMRX104IKS70601HHRX104 IKS90601HHRX104 VKS71001BSRX102 VKS91001BSRX102VKS71001BBRX102 VKS91001BBRX102 Capsule filters, filters
- Higher throughput
- Absolute retention
- 100% integrity tested
- Low protein binding
- Very low hold up volume in filters
- High flow rates
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Widest range of end connections
- Products available for total scalability from a few ml to thousands of liters
- Total traceability through unique serial number for each filter
- Individual certificate of quality for each device
- Sterilizable by Gamma irradiation or autoclaving (1 cycle)
Sterile Filtration of :
- Cell culture media
- Cell culture media containing serum
- Media additives
- Final product concentrates
Construction |
Membrane |
Hydrophilic PES |
Final Filter Pore Size |
0.2μm |
Prefilter Membrane |
0.5μm PES |
Support Layers |
Polyester |
Plastic parts |
Gamma Stable Polypropylene |
Size |
Size |
|
Effective Filtration Area |
|
Dimension (End to End) - ¼" - 3/8" Stepped Hose Barb I/O |
|
Dimension (End to End) - ¾" Sanitary Flange I/O |
|
Dimension (End to End) - ⅛" Hose Barb I/O |
|
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip Outlet |
|
Dimension (End to End) - ¼" Single Step Hose Barb I/O |
|
Operational Radius (with Vent/ Drain) |
|
Integrity Testing / Retention |
Bubble Point |
> 50 psi (3.52 Kg/cm² ) with Water |
Max. Air Diffusion Flows (10") |
< 30 ml/min @ 37 psi (2.6 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 Irradiation |
Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized. |
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 |
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 3 liter flush |
Indirect Food Additive |
Comply with USFDA 21 CFR Part 177.1520 |
Extractables with WFI |
Passes test as per USP |
Oxidizable Substances |
Within limits as specified in USP |
Quality Management System |
ISO-9001 Certified |
USFDA |
DMF No. 015554 |
pH Compatibility |
Compatible with pH range of 1-10 |
AseptiPrime® KS- γ (25mm) PES Membrane Capsule filters
Type | AseptiPrime® KS-γ (0.5μm optimized pre-filter)
| IKX7 | | | Pore Size | Pore Size | Code | 0.2µm | 01
| | I/O Connection | Connection | Code | Female Luer lock | M | Male Luer Slip | N | ⅛" Hose Barb
| H
| | 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 for Non Sterile: IKX70601MNRX104 Example for Gamma Sterile: IKX70601MNXX304
AseptiPrime® KS- γ (50mm) PES Membrane Capsule filters
Type | AseptiPrime® KS-γ (0.5μm optimized pre-filter)
| VKX7 | | | Pore Size | Pore Size | Code | 0.2µm | 01
| | I/O Connection | 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 | |
* Gamma sterilized filters cannot be gamma irradiated again
Example:
Example for Non Sterile: VKX71001BBRX102 Example for Gamma Sterile: VKX71001BBXX302