Mycoplasma Removal Filters for Applications That Demand Enhanced Sterilization Assurance

Offered in a range of scalable formats, Fluorodyne II DJL polyvinylidene fluoride (PVDF) membrane filters have been designed to sterilize fluids when a level of safety beyond a 0.2 µm-rated filter is required. Rated at 0.1 µm, these filters are recommended for the following applications:

• Upstream processing applications with mycoplasma contamination risk (growth media, bioreactor additions)
• Formulation and filling applications (filtration of drug product under process conditions where a 0.2 µm filter cannot be validated)

Superior Performance

A serial layer (0.2/0.1 µm) PVDF membrane construction produces high flow rates with low-fouling feeds.

Benefits From Using Fluorodyne II DJL Filters

• Hydrophilic PVDF membrane ensures maximum transmission of active ingredients and other fluid components
• Fast and easy scale-up: all process development-scale filter formats are designed to scale directly to larger cGMP filter configurations
• Low amount of leachables in filtrate

Security of Supply and Reliability of Performance

Pall manufactures the PVDF membranes used in Fluorodyne II DJL filter discs, capsules, and cartridges. All Fluorodyne II DJL filters are made at manufacturing sites in Puerto Rico and the United Kingdom.

Scientifically Validated

Fluorodyne II DJL filters are validated to have a sterilizing grade claim through bacterial challenge using Brevundimonas diminuta (ATCC 19146) at a challenge level of 10⁷ cfu/cm². Fluorodyne II DJL filters are further validated for reliable removal of Acholeplasma laidlawii mycoplasma (ATCC 28206) with a typical titer reduction (TR) > 8 LRV.