ABSTRACT
If the isolator process is an aseptic one, and especially if the process is the filling of product into containers, the real microbiological challenge will be the broth or media fill trial. Andrew Bill of the MHRA (1996) makes the point that, if the media fill produces a contamination rate of 1 in 1,000, then the actual product will also have an infection rate of 1 in 1,000. This means that a major manufacturer producing 1 million units per month will sell 12,000 infected units in a year.
