Aervent® Hydrophobic Cartridge and Disposable Capsule Filters
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FAQ
| Pergunta | Resposta |
|---|---|
| What is the difference between Aerex and Aervent? | Aervent cartridges have a 0.2µ PTFE membrane and are used in pharmaceutical applications where it is critical to use a phobic filter that has proven bacterial and viral retention capabilities. Common applications for Aervent are fermentation air applications, bioreactor inlet and outlet filtration and sterile process gases. Aervent filters have a liquid bacterial retention claim as well as a virus aerosol retention claim. Aerex filters also have a 0.2µ PTFE membrane but they do not come with a liquid bacterial retention claim. Common applications for Aerex include bulk intermediate manufacturing and non-pharamaceutical applications such as industrial fermentation. Aerex filters do have a virus aerosol retention claim. |
| Can I mount my tank vent filter horizontally? | Millipore recommends that you mount your vent filter vertically because it will facilitate the draining of any condensate that may collects in the bottom of the housing. If condensate builds up in the housing, it can cause part of the filter to becomes wet which will prevent air from passing through. |
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Produtos relacionados por: Application Facete
| Antibody Purification |
| Process Water Analysis |
| Dialysis and Filtration |
Produtos relacionados por: Brand Facete
| Aervent® |
Categorias
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Gas > Aervent |
Description
The 0.2 µm hydrophobic Aervent® polytetrafluoroethylene (PTFE) membrane provides sterility assurance, high flow rates and throughput. The Aervent® membrane contributes to clean processes due its non-fiber releasing properties.
Hydrophobic Aervent® cartridge filters provide high throughput with minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles.
Regulatory Compliance
Filters with hydrophobic Aervent® membrane are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard and are shipped with a Certificate of Quality. Each cartridge filter is integrity tested during manufacturing.
For traceability and easy identification, each filter is labeled with the product name, lot number and serial number.
Multiple Formats Available
Hydrophobic Aervent membranes are available in two device formats, one pore size, and multiple configurations that vary by filtration area and type of inlet/outlet connection.
- Opticap® XL disposable capsule filters
- Cartridge filters
Typical Applications
Aervent® hydrophobic filters will remove particles and microorganisms from gases and liquids. The sterilizing-grade rating is based on HIMA liquid bacterial retention challenge. In gases this filter will remove contamination down to 0.01 µm. Cartridge filters will also sterilize alcohol streams.
| Opticap® XL 2 | Opticap® XL 4 | Opticap® XL 5 | Opticap® XL 10 | per 10-inch cartridge | |
| Materials of Construction | |||||
| Filter Membrane | Polytetrafluoroethylene (PTFE) | Polytetrafluoroethylene (PTFE) | Polytetrafluoroethylene (PTFE) | Polytetrafluoroethylene (PTFE) | Polytetrafluoroethylene (PTFE) |
| Structural Components | Polypropylene | Polypropylene | Polypropylene | Polypropylene | Polypropylene |
| Filter Supports | Polypropylene | Polypropylene | Polypropylene | Polypropylene | Polypropylene |
| O-rings | Silicone (SI) | Silicone (SI) | Silicone (SI) | Silicone (SI) | Silicone (SI) |
| Pore Size | 0.2 µm | 0.2 µm | 0.2 µm | 0.2 µm | 0.2 µm |
| Filtration Area | 0.1 m² | 0.21 m² | 0.32 m² | 0.65 m² | 0.65 m² |
| Maximum Differential Pressure, bar (psid) | Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 4.1 bar (60 psid) @ 25 °C, intermittent | Forward: 5.5 bar (80 psid) @ 25 °C; 1.8 bar (25 psid) @ 80 °C. Reverse: 4.1 bar (60 psid), intermittent | |||
| Maximum Inlet Pressure, bar (psi) | 5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C | N/A | |||
| Integrity Testing | |||||
| Bubble Point at 23 °C | ≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water | ||||
| Air Diffusion at 23 °C | ≤9 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water | ≤12 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water | ≤24 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water | ||
| HydroCorr | ≤0.12 mL/min @ 2.6 bar (38 psig) | ≤0.25 mL/min @ 2.6 bar (38 psig) | ≤0.38 mL/min @ 2.6 bar (38 psig) per sample | ≤0.75 mL/min @ 2.6 bar (38 psig) per sample | ≤0.75 mL/min @ 2.6 bar (38 psig) per 10 in cartridge |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology | ||||
| Bacterial Endotoxin | Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. | ||||
| Bacterial Aerosol Growth | Retains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 10⁷ CFU/cm². | ||||
| Sterilization | 30 autoclave cycles of 30 min @ 135 °C; not in-line steam sterilizable | 150 (100 forward/50 reverse) SIP cycles of 30 min @ 145 °C | |||
| 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> Biological Reactivity in vivo test for Class VI Plastics. This product is non-cytotoxic per ISO® 10993-5 and USP <87> Biological reactivity in vitro tests. | ||||
| European Pressure Equipment Directive | ****ONLY APPLIES TO 10-inch CARTRIDGE (NO XL CAPSULES) We certify that the Opticap® XL10 capsule filter complies with the European Pressure Equipment Directive, 2014/68/EU of 15 May 2014. The Opticap® XL10 capsule filter has been classified under Article 4 § 3 of the Directive 2014/68/EU. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 4 § 3 of the Directive 2014/68/EU, the Opticap® XL10 capsule filter does not bear the CE mark. |
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Typical Air Flow Rate vs Pressure Drop at 25 °C
