AseptiSure® HSR Standard
MDI AseptiSure® HSR Polyethersulfone (PES) membrane mini cartridge filters type AseptiSure® HSR are designed to withstand high pressure differential upto 0.3 Kg/cm² (5 psi) at high steam sterilization temperatures of up to135 °C.
These filters with Polyethersulfone membrane and Polypropylene support layers offer pH compatibility from 1 to14, and are thus ideal for use with acidic as well as alkaline solutions.
MDI AseptiSure® HSR Mini Cartridge filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates.
- Low protein binding
- High throughputs
- Long service life
- Non-toxic material of construction
- Heat sealed, no glues or adhesives
- Each filter comes with an individualcertificate of quality
- Total traceability: Unique Identification number is laseretched on each filter
- Sterile Filtration of Culture media for mammalian cell culture
| Construction | |||||
| Membrane | Polyethersulfone | ||||
| Final Filter Pore Size |
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| Support Layers | Polypropylene | ||||
| Body and Core | Polypropylene | ||||
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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 |
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