Aervent® Membrane in Optiseal®-M Filters
Optiseal-M filters with Aervent membrane are designed for sterilizing applications, removing particles and microorganisms from gases and solvents.
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Produtos relacionados por: Brand Facete
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Categorias
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Gas > Aervent |
Description
Optiseal™-M filters with Aervent™ membrane are 0.2 µm hydrophobic cartridges. They are designed for sterilizing applications, removing particles and microorganisms from gases and solvents. They are made with PTFE membrane and polypropylene components for broad application compatibility. Optiseal-M filters with Aervent membrane are designed to be used with Millidisk housings.
Each unit is 100% integrity tested during manufacturing to guarantee integrity. Optiseal-M filters with Aervent membrane are designed, developed and manufactured in accordance with a Quality Management System approved by an accredited registered body to an ISO® 9000 Quality Systems Standard.
Typical Applications
Optiseal-M Aervent hydrophobic cartridges will remove particles and microorganisms from gases and liquids for low flow rates. In gases this filter will remove contamination down to 0.01 µm.
- Sterile tank venting such as fruit containers transportation or fruit juice storage
- Fermentation air applications
- Bioreactor inlet and outlet filtration
- Autoclaves
- Sterile process gases
| Materials of Construction | |
| Filter Membrane | Polytetrafluoroethylene (PTFE) |
| Structural Components | Polypropylene |
| Filter Supports | Polypropylene |
| O-rings | Silicone (SI) |
| Pore Size | 0.2 µm |
| Filtration Area | 0.05 m² |
| Maximum Differential Pressure, bar (psid) | Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 4.1 bar (60 psid) |
| Bubble Point at 23 °C | ≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water |
| Bacterial Retention | Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. |
| Sterilization | 80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °C |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. |
| Non-Fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). |
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. |
| Certificate of Quality | Each cartridge is shipped with a Certificate of Quality which summarizes our stringent manufacturing and quality standards. |
Typical Air Flow Rate vs Pressure Drop at 25 °C
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