Emflon™ II membrane in Kleenpak™ capsules

Highly-retentive Emflon™ II membrane for sterility assurance

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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