Cytiva, KA2V002PV1, Emflon™ II membrane in Kleenpak™ capsules

Kleenpak Emflon II 0.2um
Emflon™ II membrane in Kleenpak™ capsules, a Pall Life Sciences product, delivers scalable, gamma-compatible, sterilizing grade air filtration for use on process gas and vent applications.
For 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.
Kleenpak™ capsules with Emflon™ II membrane delivers scalable, gamma-compatible, sterilizing grade air filtration for use on process gas and vent applications. 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. Key features Highly-retentive Emflon™ II membrane for sterility assurance High flow-rates associated with low differential pressure enable the use of small filters – reduction of installation and operating costs Gamma-irradiatable, autoclavable or available pre-sterilized for maximum convenience Integrity testable using the forward flow and bubble point test Choice of connection options for enhanced flexibility Biological tests Meets USP biological reactivity tests in vivo, in accordance with USP class VI plastics at 121°C High quality standards Validated in liquids with Brevundimonas diminuta (ATCC 19146) at a challenge level of 10 7 organisms/cm 2 of filter area 100 % integrity tested during manufacturing Identified by a lot number and unique serial number for complete traceability of manufacturing history and for user traceability systems Comprehensive batch/release testing supported with a pharmaceutical certificate of test for each filter Validation guide available Manufactured under a quality management system certified to ISO 9001:2015