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
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Low Protein Binding:
| Results in increased overall product yield and higher throughputs with biological streams.
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High Throughputs:
| Translates to lower filtration costs, less number of filter changes and overall economy of operations.
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Low Extractables:
| Means less addition to impurity profile of the biological product from the filters.
|
- Sterile Filtration of Culture media for mammalian cell culture
| Construction |
| Membrane |
Hydrophilic PES |
| Final Filter Pore Size |
0.1µm |
| Prefilter Pore Size |
0.2µm or 0.45 µm |
| Support Layers |
Polyester |
| Body and Core |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
|
| Integrity Testing / Retention |
| Bubble Point |
> 26 psi (1.82 Kg/cm²) with 50% IPA > 65 psi (4.56 Kg/cm²) with Water |
| Microbial Retention |
LRV >7 for Acholeplasma laidlawii (ATCC 23206) 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 | AseptiSure® KS (0.2µm upstream)
| CPK1 | AseptiSure® KS (0.45µm upstream)
| CPKX | | | Size | | Size | Code | | 2.5" | 50 | | 5" | 53 | | | Pore Size | Pore Size
| Code | | 0.1µm | 36 | | | 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 | |
*G0 adapter code is not available with any elastomer. Pleasemention XX in place of elastomer code while ordering
**Adapter code F0 is available only in 5” cartridge filters
Example :
Example for Non Sterile: CPKX5336E0SS101
