AseptiSure® HL Standard
MDI AseptiSure® HL large area PES membrane cartridge filters offer very high flow rates to meet and exceed process efficiency requirements in large volume parenterals and in case of difficult to filter solutions.
MDI AseptiSure® HL filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates.
- Low protein binding
- High flow rates
- High throughputs
- Long service life
- Comply with USP <788> for particulate matter in injections
- Non-toxic material of construction
- Absolute retention
- 100% integrity tested
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Unique identification number is laser etched on each filter
- Individual certificate of quality for each device
- Sterilizable by Autoclaving/Steaming in place (SIP)
Sterilizing filtration of:
- Large Volume Parenterals
- Difficult to filter solutions
| Construction | |||||||
| Membrane | Hydrophilic PES | ||||||
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| Support Layers | Polyester | ||||||
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| Effective Filtration Area (Nominal) |
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| Integrity Testing / Retention | |||||||
| Pore Size | 0.2 μm | ||||||
| Air Diffusion Flow with Water |
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| Microbial Retention | LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² | ||||||
| Bubble Point (with water) | > 50 psi (3.52Kg/cm²) | ||||||
| Operational | |||||||
| Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||||||
| Max. Differential Pressure | 50 psi (3.5 Kg/cm²) @ 25 °C | ||||||
| Reverse Pressure | < 0.7 Kg/cm² (10 psi) @ 25 °C | ||||||
| Sterilization | Autoclavable/In-line steam sterilizable at 135 ° C for 30 minutes, 25 cycles | ||||||
| Assurance | |||||||
| Toxicity | Passes Biological Reactivity tests, 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 as per USP <85> | ||||||
| Bioburden | Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 | ||||||
| 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 for TOC <643> and Conductivity <645> after flush with specified volume | ||||||
| Indirect Food Additive | All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 | ||||||
| Extractables with WFI | Passes NVR test as per USP <661> | ||||||
| Oxidizable Substances | Passes test as per USP <1231> | ||||||
| Particle Shedding | The filtrate complies with USP <788> test for particulate matter in injections | ||||||
| Quality Management System | ISO-9001 Certified | ||||||
| pH Compatibility | Compatible with pH range of 1-10 | ||||||
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*FV is available in Adapter code A0 (7P) adapter and A1 (7P without fin) only
Example :
| CPH0 | 64 | 01 | A1 | SS | 1 | 01 |
| File Type | Download |
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| Datasheet | Download |
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