![]() ![]() Gamma irradiation maximum dosage (G option only): Up to 50 kGy.Maximum operating pressure: 3.5 bar (50 psi) at 40 ☌ġ In air/nitrogen gas service or other compatible fluids, which do not soften, swell, or adversely affect the filter or its materials of construction. ![]() Vent and drain valve O-rings: Ethylene propylene (EPDM).Support and drainage layers: Polypropylene.Manufactured under a quality management system certified to ISO 9001:2015.Comprehensive batch/release testing supported with a pharmaceutical certificate of test for each filter.Identified by a lot number and unique serial number for complete traceability of manufacturing history and for user traceability systems.100 % integrity tested during manufacturing.Validated in liquids with Brevundimonas diminuta (ATCC 19146) at a challenge level of 10 7 organisms/cm 2 of filter area.Meets USP biological reactivity tests in vivo, in accordance with USP class VI plastics at 121☌.Choice of connection options for enhanced flexibility.Integrity testable using the forward flow and bubble point test.Gamma-irradiatable, autoclavable or available pre-sterilized for maximum convenience.High flow-rates associated with low differential pressure enable the use of small filters – reduction of installation and operating costs.Highly-retentive Emflon II membrane for sterility assurance.With a comprehensive validation and quality package, Mini Kleenpak capsules with Emflon II membrane are the perfect air filter technology to implement through clinical development to licensed drug manufacture. Mini Kleenpak capsules with Emflon II membrane delivers scalable, gamma-compatible, sterilizing grade air filtration for use on process gas and vent applications. Gamma Compatible, Sterilizing Grade Air Filtrationįor single-use installations, from upstream to final formulation and fill, Emflon II membrane is the go-to gas filter for safeguarding cell cultures and drug product from adventitious bacterial and viral contamination. ![]()
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