AseptiSure® HS Mini
MDI AseptiSure® HS PES membrane mini cartridge filters are high temperature resistant filtration devices. These are designed to withstand high pressure differential at high temperature steam sterilization upto 135°C.
AseptiSure® HS cartridge filters with polyethersulfone membrane serial layers offer enhanced throughputs, thus ensuring better economics.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:
- Proteinaceous liquids where minimum protein loss is desired, such as sera, culture soups and recombinant proteins, antibodies etc
- Cell culture media
- Buffers
- Small volume parenterals
- Large volume parenterals
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| Membrane | Polyethersulfone | ||
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| Support Layers | Polyester | ||
| Body and Core | Polypropylene | ||
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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 | ||
| Sterilization | 5 Autoclave/In-line steam sterilization cycles at 135°C for 30 min., ∆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 | Passes USP test for particulates 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 | ||
| pH Compatibility | Compatible with pH range of 1-10 | ||
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* 0.45µm cartridge filter are available with 0.65µm or 0.8µm upstream layer only
**Adapter code “G0” does not come with Elastomer
***Adapter code F0 is available only in 5” cartridge filters
Example :
| CPH5 | 50 | 01 | E0 | SS | 1 | 01 |
Example for Non Sterile: CPH55001E0SS101
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