0.1µm AseptiSure® HS Mini
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 | ||
| 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 @ Δp= 5psi (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 | ||
| Non Fiber Releasing | Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release | ||
| TOC and Conductivity | 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 | ||
| Particle Release | The filtrate complies with USP <788> test for particulate matter in injections | ||
| 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 | ||
| Quality Management System | ISO-9001 Certified | ||
| USFDA | DMF No. 015554 | ||
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*G0 adapter code is not available with any elastomer. Please mention XX in place of elastomer code while ordering
**Adapter Code F0 is available only in 5” cartidge filters
Example :
| CPHX | 50 | 36 | E0 | SS | 1 | 01 |
Example for Non Sterile: CPHX5036E0SS101
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