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