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,
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
