IKSX0636MNXX104 IKS10636MNXX104 IKSX0636MNRX104 IKS10636MNRX104IKSX0636HHXX104 IKS10636HHXX104 IKSX0636HHRX104 IKS10636HHRX104IKSX0636BBXX104 IKS10636BBXX104 IKSX0636BBRX104 IKS10636BBRX104IKSX0636MNXX304 IKS10636MNXX304 IKSX0636HHXX304 IKS10636HHXX304 IKSX0636BBXX304 IKS10636BBXX304 VKSX1036BSXX102 VKS11036BSXX102 VKSX1036BSRX102 VKS11036BSRX102VKSX1036BBXX102 VKS11036BBXX102 VKSX1036BBRX102 VKS11036BBRX102VKSX1036BSXX302 VKS11036BSXX302 VKSX1036BBXX302 VKS11036BBXX302
Capsule filters, filters, asepticap,
AseptiCap® KS-γ (with vent) (0.2 μm Upstream)
| VKS1 |
AseptiCap® KS-γ (with vent) (0.45 μm Upstream)
| VKSX |
AseptiCap® KS-γ (without vent) (0.2 μm Upstream)
| IKS1 |
AseptiCap® KS-γ (without vent) (0.45 μm Upstream)
| IKSX |
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
|
Low Protein Binding:
| Results in increased overall product yield
|
High Throughputs:
| Translates to lower filtration costs, less number of filter changes and overall economy of operations.
|
Low Extractables:
| Mean less addition to impurity profile of the biological product from the filters.
|
Sterile Filtration of:
- Cell culture media
- Cell culture media containing serum
- Media additives
- Final product concentrates
Construction |
Membrane |
0.1 µm Hydrophilic PES |
Prefilter Membrane |
0.2 µm or 0.45 µm Hydrophilic PES |
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 |
> 26 psi (1.82 Kg/cm²) with 50% IPA > 65 psi (4.56 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 |
|
pH Compatibility |
Compatible with pH range of 1-14 |
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 |
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 500ml flush |
Particle Release |
Passes USP test for particulates in injections |
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® KS- γ (25mm)
Type | AseptiCap KS®-γ (0.2μm Upstream)
| IKS1 | AseptiCap KS®-γ (0.45μm Upstream)
| IKSX | | | 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
| ¼" Hose Barb | B | | 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: IKSX0636MNRX104 Example for Gamma Sterile: IKSX0636MNXX304
AseptiCap® KS- γ (50mm)
Type | AseptiCap® KS-γ (with vent) (0.2 μm Upstream)
| VKS1 | AseptiCap® KS-γ (with vent) (0.45 μm Upstream)
| VKSX | AseptiCap® KS-γ (without vent) (0.2 μm Upstream)
| IKS1 | AseptiCap® KS-γ (without vent) (0.45 μm Upstream)
| IKSX | | | 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 irradiated filters can not be gamma sterlized 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: VKSX1036BBRX102 Example for Gamma Sterile: VKSX1036BBXX302