cartridge filters, filters
Consistent and Reliable Quality:
| AseptiSure® cartridge filters are produced with ISO 9001-2008 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 and higher throughputs with biological streams.
|
High Throughputs:
| Translates to lower filtration costs, less number of filter changes and overall economy of operations.
|
Low Extractables:
| Means less addition to impurity profile of the biological product from the filters.
|
- Sterile liquid filtration
- Filtration of proteinaceous liquid where minimum protein loss is desired, such as sera, culture soups and recombination proteins, antibodies etc.
- Filtration of media, buffers etc.
- Water filtration
| Construction |
| Membrane |
Hydrophilic PES |
| Final Filter Pore Size |
|
| Prefilter Pore Size |
| 0.8 µm, 0.65 µm, 0.45 µm |
0.65 µm, 0.8 µm |
|
| Support Layers |
Polyester |
| Body and Core |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
|
| Integrity Testing / Retention |
| Bubble Point |
| > 50psi (3.51Kg/cm²) with Water | > 30psi (2.11Kg/cm²) with Water |
|
| Microbial Retention |
| LRV > 7 for Brevundimonas diminuta (ATCC 19146) per cm² | LRV > 7 for Serratia marcescens (ATCC 14756) per cm² |
|
| Operational |
| Max. Operating Temperature |
80 °C @ < 2 Kg/cm² (30 psi) |
| Max. Differential Pressure |
3.5 Kg/cm² (50 psi) @ 25 °C |
| Reverse Pressure |
< 0.7 Kg/cm² (10 psi) @ 25 °C |
| Sterilization |
Autoclavable/In-line steam sterilizable at 121 ° C for 30 minutes, 25 cycles |
| 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 test as per USP |
| Good Manufacturing Practice |
These products are manufactured in a facility which adheres to Good Manufacturing Practices. |
| Oxidizable Substances |
Within limits as specified in USP |
| Particle Shedding |
Passes USP test for particulates in injectables. |
| TOC/Conductivity at 25 °C |
Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush |
| Quality Management System |
ISO-9001 Certified |
| USFDA |
DMF No. 015554 |
| pH Compatibility |
Compatible with pH range of 1 - 10 |
| Type | | CPPKS (with 0.45µm Upstream Layer) | CPKX | | CPPKS (with 0.65µm Upstream Layer) | CPK3 | | CPPKS (with 0.8µm Upstream Layer) | CPK5 | | | Size | | Size | Code | | 2.5" | 50 | | 5" | 53 | | | Pore Size | | Pore Size | Code | | 0.2µm | 01 | | 0.45µm* | 02 | | | Adapter | | Code | | 4463 | E0 | 4463B
| H0 | | 4440 | U0 | Seal-K
| G0** | Seal-O
| F0*** | Seal-M
| J0 | | | Elastomer | | Code | | Silicone | SS | | | Sterility | | Code | | Non Sterile | 1 | | | Pack Size | | Pack Size | Code | | 1 | 01 | |
*0.45µm cartridge filters are available with 0.65µm or 0.8µm upstream layer only
**G0 adapter code is not available with any elastomer. Please mention XX in place of elastomer code while ordering
***Adapter code F0 is available only in 5” cartridge filters.
Example :
Example for Non Sterile: CPKX5001E0SS101
