Cartridge filters, filters
- Absolute retention
- 100% integrity tested
- Low protein binding
- Low extractables
Sterile filtration of:
- Cell culture media
- Cell culture media containing serum
- Media additives
- Buffers
- pH adjusters
- Final product concentrates
Construction |
Membrane |
Hydrophilic Polyethersulfone |
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 (3.52 Kg/cm²) with Water |
Microbial Retention |
LRV >7 for B.diminuta (ATCC 19146) 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 @ < 30 psi (2 Kg/cm²) |
Max. Differential Pressure |
50 psi (3.5 Kg/cm²) @ 25°C |
Reverse Pressure |
< 0.7 Kg/cm² (10 psi) @ 25 °C |
Sterilization |
In-line steam sterilizable at 135°C for 30 minutes at a maximum differential
pressure of 3 psi (0.21 kg/cm²), 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 |
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 | AseptiPrime® KS (0.5μm Upstream) | CKH7 | | Size | Size | Code | 5"* | 53 | 10" | 54 | 20" | 55 | 30" | 56 | | Pore Size | Pore Size
| Code | 0.2µm | 01 | | 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 | |
*Size 5" is available in Adapter Code A0 (7P) and A1 (7P without fin) only
**FV is available with Adapter code A0 (7P) and A1 (7P without fin) only
Example :