Article
Single-Use TFF Systems - A New Era
June 1, 2011
•Article: Single-Use TFF Systems – A New Era
By Pall Life Sciences - BioPharmaceuticals
Only a few years ago, single-use tangential flow filtration (TFF) from bench scale to full production was not a practical consideration for the vast majority of pharmaceutical manufacturers. Since then, significant product development has transformed the status of single-use TFF into a viable option for many processes. A survey in 20091 revealed over 74% of respondents were using single-use TFF in scale up and clinical production, and 60% in commercial production.
Reduction or elimination of cleaning has been the major driving force, but the complexity of tangential flow systems presented a major challenge in replacing cleanable systems. For example, the need for high pressures, re-circulating flow paths, pumps, valves, sensors and automation had to be addressed, and the performance shown to be comparable to re-usable systems. To meets these needs, a combination of single-use components and manifolds, interfacing with a re-usable hardware platform, had to be developed.
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