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 |
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Prefilter Pore Size |
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Support Layers | Polypropylene | ||||
Body and Core | Polypropylene | ||||
Size | |||||
Size |
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Effective Filtration Area (Nominal) |
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Integrity Testing / Retention | |||||
Bubble Point |
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Microbial Retention |
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Air Diffusion Flow (10") |
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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) |
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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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*Size 5" is available in Adapter Code A0 (7P) and A1 (7P without fin) only
** 0.45µm cartridge filter are available with 0.65µm or 0.8µm upstream layer only
***FV is available with Adapter code A0 (7P) and A1 (7P without fin) only
Example :
CHRX | 55 | 01 | A0 | SS | 1 | 01 |
Datasheet | Download |