| CPK25301A1SS101 |
| CPK25501A0SS101 |
| CPK35402A0SS101 |
| CPK35502A0SS101 |
| CPK35602A0SS101 |
| CPK55301A0SE101 |
| CPK55301A0SR101 |
| CPK55301A0SS101 |
| CPK55301A0SV101 |
| CPK55301E0SE101 |
| CPK55301E0SR101 |
| CPK55301E0SS101 |
| CPK55301E0SV101 |
| CPK55301F0SE101 |
| CPK55301F0SR101 |
| CPK55301F0SS101 |
| CPK55301F0SV101 |
| CPK55301G0XX101 |
| CPK55301H0SE101 |
| CPK55301H0SR101 |
| CPK55301H0SS101 |
| CPK55301H0SV101 |
| CPK55301J0SE101 |
| CPK55301J0SR101 |
| CPK55301J0SS101 |
| CPK55301J0SV101 |
| CPK55302A0SE101 |
| CPK55302A0SR101 |
| CPK55302A0SS101 |
| CPK55302A0SV101 |
| CPK55302E0SE101 |
| CPK55302E0SR101 |
| CPK55302E0SS101 |
| CPK55302E0SV101 |
| CPK55302F0SE101 |
| CPK55302F0SR101 |
| CPK55302F0SS101 |
| CPK55302F0SV101 |
| CPK55302G0XX101 |
| CPK55302H0SE101 |
| CPK55302H0SR101 |
| CPK55302H0SS101 |
| CPK55302H0SV101 |
| CPK55302J0SE101 |
| CPK55302J0SR101 |
| CPK55302J0SS101 |
| CPK55302J0SV101 |
| CPK55401A0SE101 |
| CPK55401A0SR101 |
| CPK55401A0SS101 |
| CPK55401A0SV101 |
| CPK55401B0SE101 |
| CPK55401B0SR101 |
| CPK55401B0SS101 |
| CPK55401B0ST101 |
| CPK55401B0SV101 |
| CPK55401C0SE101 |
| CPK55401C0SR101 |
| CPK55401C0SS101 |
| CPK55401C0SV101 |
| CPK55401D0SE101 |
| CPK55401D0SR101 |
| CPK55401D0SS101 |
| CPK55401D0SV101 |
| CPK55402A0SE101 |
| CPK55402A0SR101 |
| CPK55402A0SS101 |
| CPK55402A0SV101 |
| CPK55402B0SE101 |
| CPK55402B0SR101 |
| CPK55402B0SS101 |
| CPK55402B0ST101 |
| CPK55402B0SV101 |
| CPK55402C0SE101 |
| CPK55402C0SR101 |
| CPK55402C0SS101 |
| CPK55402C0SV101 |
| CPK55402D0SE101 |
| CPK55402D0SR101 |
| CPK55402D0SS101 |
| CPK55402D0SV101 |
| CPK55501A0SE101 |
| CPK55501A0SR101 |
| CPK55501A0SS101 |
| CPK55501A0SV101 |
| CPK55501B0SE101 |
| CPK55501B0SR101 |
| CPK55501B0SS101 |
| CPK55501B0ST101 |
| CPK55501B0SV101 |
| CPK55501C0SE101 |
| CPK55501C0SR101 |
| CPK55501C0SS101 |
| CPK55501C0SV101 |
| CPK55501D0SE101 |
| CPK55501D0SR101 |
| CPK55501D0SS101 |
| CPK55501D0SV101 |
| CPK55502A0SE101 |
| CPK55502A0SR101 |
| CPK55502A0SS101 |
| CPK55502A0SV101 |
| CPK55502B0SE101 |
| CPK55502B0SR101 |
| CPK55502B0SS101 |
| CPK55502B0ST101 |
| CPK55502B0SV101 |
| CPK55502C0SE101 |
| CPK55502C0SR101 |
| CPK55502C0SS101 |
| CPK55502C0SV101 |
| CPK55502D0SE101 |
| CPK55502D0SR101 |
| CPK55502D0SS101 |
| CPK55502D0SV101 |
| CPK55601A0SE101 |
| CPK55601A0SR101 |
| CPK55601A0SS101 |
| CPK55601A0SV101 |
| CPK55601B0SE101 |
| CPK55601B0SR101 |
| CPK55601B0SS101 |
| CPK55601B0ST101 |
| CPK55601B0SV101 |
| CPK55601C0SE101 |
| CPK55601C0SR101 |
| CPK55601C0SS101 |
| CPK55601C0SV101 |
| CPK55601D0SE101 |
| CPK55601D0SR101 |
| CPK55601D0SS101 |
| CPK55601D0SV101 |
| CPK55602A0SE101 |
| CPK55602A0SR101 |
| CPK55602A0SS101 |
| CPK55602A0SV101 |
| CPK55602B0SE101 |
| CPK55602B0SR101 |
| CPK55602B0SS101 |
| CPK55602B0ST101 |
| CPK55602B0SV101 |
| CPK55602C0SE101 |
| CPK55602C0SR101 |
| CPK55602C0SS101 |
| CPK55602C0SV101 |
| CPK55602D0SE101 |
| CPK55602D0SR101 |
| CPK55602D0SS101 |
| CPK55602D0SV101 |
| CPK55801E0SS101 |
| CPK55801F0SS101 |
| CPK56401A0SS101 |
| CPKX5301A0SS101 |
| CPKX5301A1SS101 |
| CPKX5301E0SS101 |
| CPKX5301F0SS101 |
| CPKX5301G0XX101 |
| CPKX5301H0SS101 |
| CPKX5401A0SS101 |
| CPKX5401B0SR101 |
| CPKX5401C0SS101 |
| CPKX5401D0SS101 |
| CPKX5501A0SS101 |
| CPKX5501B0SR101 |
| CPKX5601A0SS101 |
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.
|
- Bioburden reduction from cell harvest supernatants
- Filtration of equilibrating, washing and elution buffers for chromatography columns
- Sterilization of buffers
- Sterilization of adjuvants
- Sterilization of Large Volume Parenterals
- Sterile filtration of WFI
| 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) |
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") |
| < 30ml/min @ 37 psi (2.6Kg/cm²) with Water | < 35ml/min @ 22 psi (1.54Kg/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 - 10 |
| Type | AseptiSure® KS (0.45µm Upstream)
| CPKX | AseptiSure® KS (0.65µm Upstream)
| CPK3 | AseptiSure® KS (0.8µm Upstream)
| CPK5 | | | Size | | Size | Code | | 5"** | 53 | | 10" | 54 | | 20" | 55 | | 30" | 56 | | | 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) and A1 (7P without fin) only
**Size 5" is available in Adapter Code A0 (7P) and A1 (7P without fin) only
***0.45µm Cartridge filters are available with 0.65µm or 0.8µm upstream layer only
Example :
Example for Non Sterile: CPK55301A0SS101
