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 /h2>

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