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Products (9)
Product Information
Sartopure® GA offers an outstanding flow rate at low differential pressure and are the ideal choice for air filtration in the biopharmaceutical industry. Sartopure® GA filters expand the service life time of sterilizing grade air filter systems by removal of particles from the air stream. In addition they can be used for all venting purposes that do not necessarily require an integrity testable membrane filter.
Applications
- Particle removal from air streams, e.g. pressure supplies
- Prefiltration in front of Sartofluor® GA membrane filters or any other membrane air filter
- Venting of non-pressure resistant vessels
Retention Efficiency
The excellent retention and therefore superior protection has been proven by particle retention filtration and bacterial challenge tests (aerosol tests) performed under worst case conditions. Sartopure® GA has got a LRV of 7/cm² with Bacillus subtilis var niger spores and a LRV of 6,8/cm² with Brevundimonas diminuta. Featuring a retention of 0.2 µm for gas, Sartopure® GA efficiently protects stored products, e.g. water, liquid sugar, oral solutions etc., in the pharmaceutical industry as well as the food and beverage industry.
Flow Rate
Due to the large filter area of 0.7 m²|10”, Sartopure® GA delivers a flow rate of nearly 40 m³/h at a differential pressure of 10 mbar. This means Sartopure® GA is the perfect product for high performance filling or draining of tanks and vessels.
Optimized Filter Material
Sartopure® GA’s hydrophobic material guarantees an air flow recovery of 60-80% within 30 seconds after the filter has been wetted with water. The water prevents high differential pressures, ensuring fast recovery of air flow rate e. g. after cleaning the tank with hot water | agents.
Documentation
Sartopure® GA cartridges are designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System.
Regulatory Compliance
- Filter material bacteria challenge tested with Bacillus subtilis var niger spores and Brevundimonas diminuta
- Non pyrogenic according to USP Bacterial Endotoxins
- Pass USP Plastic Class VI Test
Applications
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ApplicationAir/Gas Filtration
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IndustryPharma / Biotech / F&B
Biological Information
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Bacterial RetentionQuantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology
Compliance Information
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Bacterial Endotoxins< 0.25 EU/mL as determined by the LAL test
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Biological ReactivityAll materials of this filter element meet the requirements of the current USP Biological Reactivity tests <88> for plastics Class VI (Systemic Injection, Intracutaneous and Implantation tests).
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ExtractablesThe total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
Features
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Venting FilterYes
Materials of Construction
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Filter MaterialGlass Fiber (GF) hydrophobic
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Housing MaterialPolypropylene (PP)
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Material o-ring | sealSilicone (optional EPDM or Fluoroelastomer)
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Membrane MaterialGlass Fiber (GF) hydrophobic
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Support FleecePolypropylene (PP)
Physicochemical Information
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Gamma StableNo
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Pore Size0.2 µm
Product Information
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BrandSartopure® GA
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TypeAir/Gas Filter
Sterility/Purity
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Sterilization MethodAutoclavable & In-Line Steam Sterilizable
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Sterilizing GradeYes
Usage Protocols
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Sterilization Procedures
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In-Line Steam Sterilization at 134 °C, 20 min. at max differential pressure of 0.5 bar | 7 psi, sterilization cycles min. 50
- Autoclaving at 134°C, 2 bar | 29 psi, 30 min.
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In-Line Steam Sterilization at 134 °C, 20 min. at max differential pressure of 0.5 bar | 7 psi, sterilization cycles min. 50
The Sartocheck® 5 Filter Tester is an automatic filter integrity tester designed to cover the complete range of integrity testing from small syringe filters up to large multiround housings and tangential flow cassettes.
The Sartocheck® 5 Plus Filter Tester is an automatic filter integrity tester with automated Quality Risk Management (QRM) designed to cover the complete range of integrity testing from small syringe filters up to large multi-round housings and tangential flow cassettes.