Sterile Formulation and Filling Applications Filtration Products
The criteria for filters in the formulation and filling sector differ greatly from the ones in biotech processes. In the biotechnology area, attributes like throughput, flowrate and compatibility are important, while the area of formulation and filling require:
As the fluids in this application are usually very clean and have a flow rate that is defined by the filling machines, the new high performance membranes do not add significant benefits.
For such applications, Pall recommends the Fluorodyne II Grade DFL series of filters.
For filling processes that take a considerable amount of time(> 24 hours) or for high penetrative organism-containing fluids, the best filter choice is our Fluorodyne II Grade DJL series of filters. These filters offer much higher safety at flowrate levels of older generation 0.2 micron filters.
Over the past ten years, validation of sterilizing-grade filters, especially in the formulation and filling area, has become much more complex. Filter users now must repeat core validation of the filter product and process under worst case scenarios. Pall offers filter validation laboratories and an expert staff that is ready to assist you with validation of filters needed for your specific process.
For Sterilizing-Grade:Fluorodyne II Grade DFL (0.2 micron)
For Enhanced Sterility Assurance:Fluorodyne II Grade DJL (0.1 micron)
Pall also provides single-use filling machine manifolds, comprising tubing assembly, sterile-grade capsule filters, Kleenpak sterile connectors/disconnectors and Allegro single-use filling needles, as part of the Allegro single-use systems product range.
Kleenpak™ Sterile Connectors
Kleenpak™ Sterile Disconnectors
Allegro™ Single-Use Filling Needles