| CPKR5401A0SS101 |
| CPKR5402A0SE101 |
| CPKR5402A0SS101 |
| CPKR5402B0SE101 |
| CPKR5602A0SS101 |
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 with biological streams.
|
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.
|
- For sterile filtration of alkaline fluid streams such as pH adjusters for microbial fermentation processes.
| Construction |
| Membrane |
Hydrophilic PES |
| Pore size |
|
| Support Layers |
Polypropylene |
| Body and Core |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
| 3000cm² |
6000cm² |
12000cm² |
18000cm² |
|
| 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 |
|
| Air Diffusion Flow (10") |
| < 40 ml/min @ 37 psi (2.6 Kg/cm²) with Water |
< 35 ml/min @ 22 psi (1.54 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) |
| 40 lpm @ 0.70 Kg/cm² @ 27 °C |
55 lpm @ 0.70 Kg/cm² @ 27 °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 - 14 |
| | | Size | | Size | Code | | 5"** | 53 | | 10" | 54 | | 20" | 55 | | 30" | 56 | | | Pore Size | Pore Size
| Code | | 0.2µm | 01 | | 0.45µm | 02 | | | 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 in Adapter code A0 (7P) adapter and 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: CPKR5401A0SS101
