Many single-use devices already are available, most commonly as individual entities. More and more filter–bag and bioreactor–filter
systems have been introduced, and single-use unit operations recently have become available. Components' rapidly developing
connectivity will enhance the development of integrated systems and, potentially, totally disposable processes. Some limitations,
especially in the filling area still must be overcome (e.g., fill precision). The last step in aseptic processing has not
reached the level of disposability that one finds in the intermediate steps.
Single-use components have many benefits within aseptic processes. For example, cleaning deficiencies are a common regulatory
observation that would be eliminated by single-use equipment. The equipment also greatly reduces the risk of cross contamination.
Moreover, disposable, aseptic connectivity will reduce end-user manipulation within the process and therefore improve safety.
Some in the industry have wondered whether the benefits of single-use systems are outweighed by their environmental impact.
Further studies and thorough evaluations, however, might show that the environmental impact of cleaning and sterilizing stainless-steel
equipment is greater than that of single-use systems. This topic will likely be addressed in the near future.
Maik W. Jornitz* is vice-president of marketing FT/FRT, and Thomas Paust is global director of marketing IS, both at Sartorius Stedim North America, 5 Orville Dr., Bohemia, NY 11716, tel. 631.254.4249,
. Jornitz also is chair of the Parenteral Drug Association.
*To whom all correspondence should be addressed.
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