IKS70636MNXX104 IKS90636MNXX104IKS70636HHXX104 IKS90636HHXX104IKS70636BBXX104 IKS90636BBXX104IKS70636MNXX304 IKS90636MNXX304IKS70636HHXX304 IKS90636HHXX304IKS70636BBXX304 IKS90636BBXX304 VKS71036BSXX102 VKS91036BSXX102VKS71036BBXX102 VKS91036BBXX102 VKS71036BSXX302 VKS91036BSXX302VKS71036BBXX302 VKS91036BBXX302 IKS70636MNXX104 IKS90636MNXX104IKS70636MBXX104 IKS90636MBXX104IKS70636MMXX104 IKS90636MMXX104IKS70636MHXX104 IKS90636MHXX104 IKS70636BNXX104 IKS90636BNXX104IKS70636BBXX104 IKS90636BBXX104IKS70636BMXX104 IKS90636BMXX104IKS70636BHXX104 IKS90636BHXX104 IKS70636HNXX104 IKS90636HNXX104IKS70636HBXX104 IKS90636HBXX104IKS70636HMXX104 IKS90636HMXX104IKS70636HHXX104 IKS90636HHXX104 IKS70636MNXX304 IKS90636MNXX304IKS70636MBXX304 IKS90636MBXX304IKS70636MMXX304 IKS90636MMXX304IKS70636MHXX304 IKS90636MHXX304 IKS70636BNXX304 IKS90636BNXX304IKS70636BBXX304 IKS90636BBXX304IKS70636BMXX304 IKS90636BMXX304IKS70636BHXX304 IKS90636BHXX304 IKS70636HNXX304 IKS90636HNXX304IKS70636HBXX304 IKS90636HBXX304IKS70636HMXX304 IKS90636HMXX304IKS70636HHXX304 IKS90636HHXX304 IKS70636MNRX104 IKS90636MNRX104IKS70636HHRX104 IKS90636HHRX104IKS70636BBRX104 IKS90636BBRX104 IKS70636MNRX104 IKS90636MNRX104IKS70636MBRX104 IKS90636MBRX104IKS70636MMRX104 IKS90636MMRX104IKS70636MHRX104 IKS90636MHRX104 IKS70636BNRX104 IKS90636BNRX104IKS70636BBRX104 IKS90636BBRX104IKS70636BMRX104 IKS90636BMRX104IKS70636BHRX104 IKS90636BHRX104 IKS70636HNRX104 IKS90636HNRX104IKS70636HBRX104 IKS90636HBRX104IKS70636HMRX104 IKS90636HMRX104IKS70636HHRX104 IKS90636HHRX104 VKS71036BSRX102 VKS91036BSRX102VKS71036BBRX102 VKS91036BBRX102 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 |
0.1 μm |
Prefilter Membrane |
0.3μm or 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 |
> 26 psi (1.82 Kg/cm²) with 50% IPA > 65 psi (4.56 Kg/cm²) with Water |
Max. Air Diffusion Flows (10") |
< 29 ml/min @ 50 psi (3.52 Kg/cm²) with water |
Microbial Retention |
LRV >7 for Acholeplasma laidlawii (ATCC 23206) 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 (0.3μm optimized pre-filter)
| IKX9 | AseptiPrime® KS-γ (0.5μm optimized pre-filter)
| IKX7 | | | Pore Size | Pore Size | Code | 0.1µm | 36 | | 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:
Example for Non Sterile: IKX70636MNRX104 Example for Gamma Sterile: IKX70636MNXX304
AseptiPrime® KS- γ (50mm) PES Membrane Capsule filters
Type | AseptiPrime® KS-γ (0.3μm optimized pre-filter)
| VKX9 | AseptiPrime® KS-γ (0.5μm optimized pre-filter)
| VKX7 | | | Pore Size | Pore Size | Code | 0.1µm | 36
| | 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: VKX71036BBRX102 Example for Gamma Sterile: VKX71036BBXX302