Pall Kleenpak capsule filters with Supor polyethersulfone membrane are validated, 0.2 µm sterilizing-grade filters with built-in prefiltration to give longer filter life and lower filtration costs. The capsules are suitable for sterile filtration of a wide range of fluids including buffers, biological fluids, tissue culture media, ophthalmic products and many others. They can be used for scale-up or scale-down studies. The low protein and preservative binding of the Supor polyethersulfone membranes also ensures maximum transmission of active ingredients.

Features and Benefits

Hydrophilic polyethersulfone membrane for low adsorption and wide chemical compatibility
 Easy to wet  
 Built-in MachV prefilter layer with an asymmetric membrane for long-life and low filtration costs  
 Low hold-up volumes  (< 1 mL)
 Disposable format to avoid cleaning and cleaning validation
 Available pre-sterilized by gamma-irradiation or sterilizable by autoclaving or gamma-irradiation  

High Quality Standards

Validated with Brevundimonas diminuta (ATCC 19146) at a challenge level of
10⁷ cfu/cm².
Every production batch is routinely sampled for bacterial challenge.
Every filter is:
 Integrity-tested during manufacture with results that are continually validated against bacterial challenge
 Identified by a lot number and unique serial number for complete traceability of manufacturing history and for user’s traceability system
 Supplied with a Certificate of Test confirming the quality standards and quality control tests performed by Pall    Manufactured under a Quality Management System certified to ISO 9000

Quality and Bio-Safety

Biological Tests

 Meets USP Biological Reactivity test, in vivo, for Class VI-121 °C Plastics

Effluent Quality Tests*

Meets Cleanliness per USP Particulates in Injectables
 Non-Fiber-Releasing
 Non-Pyrogenic per USP Endotoxins (< 0.25 EU/mL)
 Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots.
A comprehensive validation guide is available upon request.