ABSTRACT
At this stage, the reader will have some idea of the history of isolation, its application, and its design. This is probably a good time to start thinking in terms of how to approach particular projects, and how to draw up a specification that would form the basis of discussion with potential isolator suppliers. It is also the time to bring in the concept of the qualification documents, since these may well underpin the whole project. All isolation projects will require some form of validation before operations can start, and many will have to be validated by the FDA, the MHRA, or other local authority. Even if the project will not require officially recognised validation, it is still a good plan to develop the project along these lines. An important part of the overall validation process is the so-called qualification documentation, consisting of design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The IQ and OQ are discussed in Chapter 6 and the PQ in Chapter 8.
