Emflon™ II membrane in Mini Kleenpak™ 20 capsules

For single-use installations, from upstream to final formulation and fill, Emflon II membrane air capsule filter is the go-to gas filter for safeguarding cell cultures and drug products from adventitious bacterial and viral contamination.

Key features

Highly retentive Emflon II membrane for sterility assurance
High flow rates associated with low differential pressure enable the use of small filters leading to a reduction of installation and operating costs
Gamma-irradiatable or autoclavable for maximum convenience
Integrity testable using the bubble point test

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
Filters supplied with a pharmaceutical certificate of test
Comprehensive validation guide available
Manufactured under a Quality Management System certified to ISO 9001:2015

Biological Tests

Meets USP biological reactivity tests in vivo, in accordance with USP class VI plastics at 121°C

Effluent Quality Tests*

Meets cleanliness per USP particulates in injectables
Non-fiber-releasing per 21CFR 211.72 and 21CFR 210.3(b)(6)
Non-pyrogenic per USP bacterial endotoxins (< 0.25 EU/mL)

* Per lot samples on rinse-up flush aliquots