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The revision to EU GMP Annex 1 has placed a greater focus on barrier technology. This guide provides a pathway to bringing online isolators in an efficient manner.
The selection and qualification of isolators is a complex process. Pharmig has prepared a guide that explains the process and offers advice on avoiding pitfalls. The guide also includes an explanation of the science of isolator decontamination and it provides a risk framework for using isolators on a day-to-day basis and for addressing problems when they occur.
