DESCRIPTION
Mini Kleenpak™ 20 capsules with Emflon™ II membrane, a Pall Life Sciences product, deliver gamma-compatible sterilizing grade air filtration for use on small-scale process gas and vent applications.
Mini Kleenpak 20 capsules are suited to both the filtration of low volumes of fluids (50 mL to 2 L) in the laboratory for filterability purposes, or in a GMP production environment where a certified filter product is essential and a single-use alternative to the cleaning of 47 mm disc holders is desired.
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 (
* Per lot samples on rinse-up flush aliquots
+852-3069 6950
sales@gugent.com.hk
