AseptiSure® HL 10", 20", 30", AseptiSure HL 10", 20", 30", CPH0, CPH06401A1SS101
- Low protein binding
- High flow rates
- High throughputs
- Long service life
- Comply with USP <788> for particulate matter in injections
- Non-toxic material of construction
- Absolute retention
- 100% integrity tested
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Unique identification number is laser etched on each filter
- Individual certificate of quality for each device
- Sterilizable by Autoclaving/Steaming in place (SIP)
Sterilizing filtration of:
- Large Volume Parenterals
- Difficult to filter solutions
| Construction |
| Membrane |
Hydrophilic PES |
| O-Rings |
| Silicone | | Viton | | EPDM | | FEP Encapsulated Viton |
|
| Support Layers |
Polyester |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
|
| Integrity Testing / Retention |
| Pore Size |
0.2 μm |
| Air Diffusion Flow with Water |
| 10” Filter | < 35 ml/min @ 37 psi (2.6 Kg/cm²) | | 20” Filter | < 70 ml/min @ 37 psi (2.6 Kg/cm²) | | 30” Filter | < 105 ml/min @ 37 psi (2.6 Kg/cm²) |
|
| Microbial Retention |
LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² |
| Bubble Point (with water) |
> 50 psi (3.52Kg/cm²) |
| 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 |
Autoclavable/In-line steam sterilizable at 135 ° C for 30 minutes, 25 cycles |
| Assurance |
| Toxicity |
Passes Biological Reactivity tests, 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 as per USP <85> |
| Bioburden |
Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 |
| Non Fiber Releasing |
Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release |
| TOC and Conductivity |
Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after flush with specified volume |
| Indirect Food Additive |
All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 |
| Extractables with WFI |
Passes NVR test as per USP <661> |
| Oxidizable Substances |
Passes test as per USP <1231> |
| Particle Shedding |
The filtrate complies with USP <788> test for particulate matter in injections |
| Quality Management System |
ISO-9001 Certified |
| pH Compatibility |
Compatible with pH range of 1-10 |
| | | Size | | Size | Code | | 10" | 64 | | 20" | 65 | | 30" | 66 | | | 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 | |
*FV is available in Adapter code A0 (7P) adapter and A1 (7P without fin) only
Example :
