| CWH15036 |
| CWH15336 |
| CWHX5036 |
| CWHX5336 |
Cartridge filters, filters
- Absolute retention
- 100% integrity tested
- Low protein binding
- Low extractables
- Cell culture media
- Growth Regulators
- Small Volume Parenterals
| Construction |
| Membrane |
Hydrophilic PVDF |
| Final Filter Pore Size |
0.1µm |
| Prefilter Pore Size |
0.2µm or 0.45 µm |
| Support Layers |
Polyester |
| Plastic parts |
Polypropylene |
| Body and Core |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
|
| Integrity Testing / Retention |
| Bubble Point |
> 31psi (2.18Kg/cm²) with 50%
IPA/Water Solution |
| Microbial Retention |
LRV >7 for A. 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/ Inline steam sterilizable at 135°C for 3 cycles of 30 minutes each |
| 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 |
| Type | AseptiSure® WS (0.2µm upstream)
| CWH1 | AseptiSure® WS (0.45µm upstream)
| CWHX | | | 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. Please mention XX in place of elastomer code while ordering
**Adapter code F0 is available only in 5” cartridge filters
Example :
