Many disposable devices are already available, most commonly as a single entity, but in some instances already connected (e.g,
filter–bag or bioreactor–filter systems). Rapidly developing connectivity will enhance the development of connected, integral
systems and potentially total disposable processes, at least in small volume scales. Some developments (e.g., filling lines)
are still necessary. The last step in aseptic processing has not reached the level one finds in the intermediate steps.
The benefits of disposability within aseptic processes are obvious. Cleaning deficiencies are a common regulatory observation,
which would be eliminated by disposable equipment use. The risk of cross contamination is greatly reduced. Moreover, disposable,
aseptic connectivity will reduce the level of end-user manipulation within the process and therefore create higher safety.
Disposability is also valuable from economic and environmental standpoints because there is a cost savings in cleaning solutions
and copious amounts of water, as well as the high energy levels required to heat the cleaning solutions or steam sterilize
Maik W. Jornitz* is group vice-president of marketing FT/FRT at Sartorius Stedim, email@example.com
. Jean-Marc Cappia is group vice-president of marketing FMT at Sartorius Stedim SA. Theodore H. Meltzer is principle of Capitola Consultancy.
*To whom all correspondence should be addressed.
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