This article is part of a special feature on single-use systems that was published in the October issue of PTE Digital, available
at http://www.pharmtech.com/ptedigital1010.
Salavadi S. Easwaran
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The willingness of the industry to use singleuse bioreactors is currently influenced by the criticality of the step, the value
of the product and the time for product development and production.
Advantages
Single-use bioreactors are considered safe, simple and clean, and the possibility of batchtobatch contamination by adventitious
microorganisms or through product crosscontamination is significantly controlled. One of the biggest advantages of such systems,
however, is flexibility. The increasing trend towards multidrug facilities demands the production of different drugs using
the same facility, with minimum time and cost. In such situations, the main manufacturing bottleneck is line clearance and
cleaning validation. Singleuse bioreactors almost completely eliminate these problems.
Additionally, single-use bioreactors provide maximum savings on the time spent to prepare the system for the next batch. As
an example, a 2-h changeover time with a single-use bioreactor would equate to a changeover time of 6–10 h with a stainless
steel bioreactor for the same product, and 3 weeks for a full product changeover.
Obstacles to adoption
There are also some key challenges associated with single-use bioreactors. In particular, such systems are noncustomisable
(since customisation would defeat their key advantage of plug and play) and can provide challenges when it comes to scale
up since the volume size is restricted (<2000 L). Disposal can also be a problem. In many cases, singleuse bioreactors are
produced from plastic derivatives. In addition to validation concerns related to potential leachable and extractable materials,
the largescale disposal of such plastic reactors on a regular basis is also an environmental concern. This is a key challenge,
particularly in countries where the disposal of plastics is strictly controlled.
Future innovations
In the future, the most important future development in singleuse bioreactor technology will be the increase in capacity to
match common largescale process capacities. Singleuse bioreactor customisation will also mark a significant innovation, whereby
the bioreactor system will fit into the existing space without compromising process requirements.
Salavadi S. Easwaran is Technology Manager-PMT, at Merck Millipore, India.
