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 107 organisms/cm2 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
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APPLICATION NOTE
EN
1.Cleaning procedures for ÄKTAprocess system external surfaces
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