0.1µm AseptiCap® KS Large
MDI AseptiCap® KS PES membrane capsule filters are validated for mycoplasma removal and are used for sterile media filtration in mammalian cell culture. The filters meet key process requirements such as high retention efficiency, very high protein recoveries, extremely low extractables, high throughputs, wide chemical compatibility etc.
| 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 | ||||
| Support Layers | Polyester | ||||
| Plastic parts | Polypropylene | ||||
| Size | |||||
| Size |
|
||||
| Effective Filtration Area (Nominal) |
|
||||
| Dimension (End to End) – 1½” Sanitary Flange Inlet ½” Hose Barb Outlet |
|
||||
| Dimension (End to End) – ¾” Sanitary Flange I/O |
|
||||
| Dimensions (End to End) Inline Capsule Filters – 1½” Sanitary Flange I/O |
|
||||
| Dimensions (End to End) Inline Capsule Filters – ½” Single Step Hose Barb I/O |
|
||||
| Clean Water Flow Rate @ 10 psi with 1½” Sanitary Flange connection |
|
||||
| Dimension (End to End) – 1″ Hose Barb I/O |
|
||||
| Operational Radius (with Vent/ Drain) |
|
||||
| Dimension (End to End) – 3/8″ Hose Barb I/O |
|
||||
| Vent and Drain | ¼” Hose Barb with Silicone “O” rings | ||||
| 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 Flow (@ 50psi (3.51 Kg/cm²) with water) |
|
||||
| Bacterial Retention | LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area | ||||
| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||||
| Max. Differential Pressure | 60 psi (4 Kg/cm²) @ 30 °C | ||||
| pH Compatibility | Compatible with pH range of 1-10 | ||||
| Sterilization By Gas | Sterilizable by Ethylene Oxide | ||||
| Sterilization By Autoclave | Autoclavable at 125°C for 30 minutes, 25 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 10 liter flush for 5” capsule filters and 20 liter flush for 10” capsule filters | ||||
| Particle Release | Passes USP test for particulates in injectables | ||||
| Indirect Food Additive | All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 | ||||
| Extractables with WFI | Passes NVR test as per USP <661> | ||||
| Oxidizable Substances | Within limits as specified in USP <1231> | ||||
| Particle Shedding | Passes USP test for particulates in injectables. | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
*T-line is not available in 5″ Capsule filter
*T-line Capsule filter are available with 1½” Sanitary Flange I/O connection only
**3/4″ Sanitary Flange end connection is available only in 5″ and 10″ capsule filters
Example:
| LKSX | 54 | 36 | EE | X | X | 1 | 01 |
Example for Non Sterile: LKSX5436EEXX101 Example for EO Sterile: LKSX5436EEXX201
Have questions or need assistance?
Our team is here to help! Contact us today, and we’ll get back to you as soon as possible.