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 | ||||
| Size | |||||
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| Effective Filtration Area (Nominal) |
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| Integrity Testing / Retention | |||||
| Bubble Point | > 26 psi (1.82 Kg/cm²) with 50% IPA > 65 psi (4.56 Kg/cm²) with Water |
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| 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 | ||||
| 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 |