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A fundamental consideration in Annex 1 is the risk posed by people and the necessity to exclude people from Grade A environments. Any personnel interaction with Grade A poses a risk. The primary means to address this is trough the use of separative devices – isolators and forms of RABS.
Once again, AM Instruments spoke to Tim Sandle, microbiologist, author and science journalist, known as one of the leading experts in the field, to discuss in the most appropriate way what challenges the pharmaceutical industry is facing in adapting the use of separative devices to the Annex 1 requirements.
