| CPH15336A0SS101 |
| CPH15336A1SS101 |
| CPH15336F0SS101 |
| CPH15436A0SS101 |
| CPH15436A1SS101 |
| CPH15536A0SS101 |
| CPH15636A0SS101 |
Cartridge filters, filters
- Low Protein Binding
- Non-toxic material of construction
- High heat Stability
- Long service life
- Heat sealed, no glues or adhesives
- Each filter comes with an individual certificate of quality
| 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.
|
Total Traceability
| Unique identification number is laser etched on each other.
|
- Sterile Filtration of Culture media for mammalian cell culture
| Construction |
| Membrane |
Polyethersulfone |
| Final Filter Pore Size |
0.1µm |
| Prefilter Pore Size |
|
| Support Layers |
Polyester |
| Body and Core |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
| 3000cm² |
6000cm² |
12000cm² |
18000cm² |
|
| Integrity Testing / Retention |
| Bubble Point |
> 31psi (2.18Kg/cm²) with 50% IPA/Water Solution |
| Microbial Retention |
LRV >7 for Acholeplasma laidlawii (ATCC 23206) per cm² |
| Air Diffusion Flow (5") |
< 15ml/min @ 50 psi (3.51 Kg/cm²) with Water |
| Air Diffusion Flow (10") |
< 29ml/min @ 50 psi (3.51 Kg/cm²) with Water |
| 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 |
| Typical Water Flow Rates (10" Cartridge filters) |
15 lpm @ 0.70 Kg/cm² @ 27 °C |
| Sterilization |
Autoclavable/In-line steam sterilizable at 135 °C for 30 minutes, 25 cycles @ ∆p=5 psi (0.3kg/cm²) |
| 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 |
The filtrate complies with USP <788> test for particulate matter 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 |
| Type | AseptiSure® HS (0.2μm Upstream)
| CPH1 | AseptiSure® HS (0.45μm Upstream)
| CPHX | | | Size | | Size | Code | | 5"** | 53 | | 10" | 54 | | 20" | 55 | | 30" | 56 | | | Pore Size | Pore Size
| Code | | 0.1µm | 36 | | | Adapter | | Code | | 7P | A0 | | 7P without fin | A1 | | 28 with fin | C0 | | 'O' | D0 | | | | Elastomer | | Code | | Silicone | SS | | Viton | SV | | EPDM | SE | | FEP Encapsulated Viton | FV* | | | Sterility | | Code | | Non Sterile | 1 | | | Pack Size | | Pack Size | Code | | 1 | 01 | |
* FV is available with Adapter code A0 (7P) A1 (7P without fin) only
** Size 5" is available in Adapter Code A0 (7P) and A1 (7P without fin) only
Example :
Example for Non Sterile: CPHX5536A0SS101
