Sterile Filtration and Bioburden Control

Many liquid filtration stages in pharmaceutical research and development and manufacturing demand the use of a filter that is validated to produce sterile effluent when challenged with a process fluid with a minimum concentration of 10⁷ CFU/cm² of Brevundimonas diminuta. Applications for sterilizing-grade filters include:

• Buffer filtration
• Cell culture process fluid filtration
• Final formulation and filling filtration
• Cell culture media filtration
• Product filtration
• Reagent filtration 
• Water filtration 

Pall is able to supply a broad range of sterilizing-grade filter products that vary sufficiently in size, design and materials of construction to satisfy the differences between these applications whether required in the laboratory, or in a GMP (Good Manufacturing Practices) manufacturing environment.

Pall-patented technologies are incorporated into several grades, contributing to higher flow rates and superior throughput performance:

• MachV
• Laid-over pleat membrane folding technology
• Small-core design

Pall offers the widest range of sterilizing-grade membrane filter materials:

• Fluorodyne® II Filter Series (PVDF)
• Supor® Filter Series (Polyethersulfone/PES)
• Fluorodyne® EX Filter Series (Hybrid of PES and Polyethersulfone)
• Ultipor® N66 Sterilizing-grade Filter Cartridges (Nylon 66)
• Posidyne® Filter Cartridges (Positively-charged Nylon 66)

Pall® sterilizing-grade capsule filters can be supplied pre-sterilized for easy integration into Allegro™ Single-use Systems.