0.1µm AseptiSure® HS Standard
MDI AseptiSure® HS PES membrane cartridge filters are high temperature resistant filtration devices, validated for Mycoplasma removal. These are designed to withstand high pressure differential at high temperature steam sterilization upto 135°C.
AseptiSure® HS is a serial layered membrane filter with a larger pore size upstream layer to protect the final layer for enhanced throughputs.
These are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates.
- High heat Stability
- Non-toxic material of construction
- Heat sealed, no glues or adhesives
- Each filter comes with an individual certificate of quality
- 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 | Polyester | ||||
| 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) A1 (7P without fin) only
** Size 5″ is available in Adapter Code A0 (7P) and A1 (7P without fin) only
Example :
| CPHX | 55 | 36 | A0 | SS | 1 | 01 |
Example for Non Sterile: CPHX5536A0SS101
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