0.1µm AseptiSure HSR 5", 10", 20", 30"
mdi AseptiSure HSR polyethersulfone (PES)membrane cartridge filters are high temperature resistant filtration devices. These are designed to withstand high pressure differential at high steam sterilization temperature upto 135°C. These filters exhibit high mechanical stability,and wide chemical compatibility even with alkaline process fluids.
These filters come with polyethersulfone membrane serial layers and Polypropylene support layers to offer 1-14 pH compatibility.
mdi AseptiSure HSR cartridge filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates.
- Low protein binding
- Non-toxic material of construction
- Multiple Autoclave
- Heat sealed, no glues or adhesives
- Each filter comes with an individual certificate of quality
- Total Traceability: Unique identification number is laser etched on each filter
- Sterile Filtration of Culture media for mammalian cell culture
| Construction | |||||
| Membrane | Polyethersulfone | ||||
| Final Filter Pore Size | 0.1µm | ||||
| Prefilter Pore Size |
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| Support Layers | Polypropylene | ||||
| Body and Core | Polypropylene | ||||
| Integrity Testing / Retention | |||||
| Bubble Point | > 31psi (2.18Kg/cm²) with 50% IPA/Water Solution | ||||
| Microbial Retention | LRV >7 for Acholeplasma laidlawii (ATCC 23206) per cm² | ||||
| Air Diffusion Flow (5") | < 15ml/min @ 50 psi (3.51 Kg/cm²) with Water | ||||
| Air Diffusion Flow (10") | < 29ml/min @ 50 psi (3.51 Kg/cm²) with Water | ||||
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| 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) | 15 lpm @ 0.70 Kg/cm² @ 27 °C | ||||
| Sterilization | Autoclavable/In-line steam sterilizable at 135 °C for 30 minutes, 25 cycles @ ∆p=5 psi (0.3kg/cm²) | ||||
| 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 | ||||
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* FV is available with 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
Example :
| CHRX | 55 | 36 | A0 | SS | 1 | 01 |
| Datasheet | Download |