AseptiCap® KS 5", 10", 20", 30"
mdi AseptiCap® KS PES membrane large capsule filters are available in a wide range of pore sizes, sizes and end connections to suit a multitude of sterilization applications in biopharmaceuticals production processes.
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. |
- Bioburden reduction from cell harvest supernatants
- Filtration of equilibrating, washing and elution buffers for chromatography columns
- Sterilization of biopharmaceuticals such as vaccines and therapeutic proteins
- Sterilization of buffers
- Sterilization of adjuvants
Construction | |||||
Membrane | Hydrophilic PES | ||||
Final Filter Pore Size |
|
||||
Prefilter Pore Size |
|
||||
Support Layers | Polyester | ||||
Body and Core | 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 |
|
||||
Dimension (End to End) - 1½" Sanitary Flange I/O |
|
||||
Dimensions (End to End) - ½" Single Step Hose Barb I/O |
|
||||
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 |
|
||||
Max. Air Diffusion Flows (10") |
|
||||
Microbial Retention |
|
||||
Operational | |||||
Max. Operating Temperature | 80 °C @ < 2 Kg/cm² (30 psi) | ||||
Max. Differential Pressure | < 4 Kg/cm² (60 psi) @ 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 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 | ||||
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> | ||||
Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices. | ||||
Oxidizable Substances | Within limits as specified in USP <1231> | ||||
Particle Shedding | Passes USP test for particulates in injectables. | ||||
TOC/Conductivity at 25 °C | 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 | ||||
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 | 01 | EE | X | X | 1 | 01 |