This question is part of the following Ask The Expert session:
Application of single-use technology does not relieve the process owner from assessing any and all appropriate risks. The infectiousness or toxicity of a process, process intermediate or end-product should be considered, with operator safety being paramount. Unlike stainless steel fermentors, single-use fermentors rely on plastic films, tubing, etc. There are risks, though low, of breaches in the integrity of the film or tubing or failures due to miss use.