ABSTRACT
This article attempts to describe the practical experience gained from consultancy and design of isolators from the early 1970s up to and including state of the art applications developed today. The principal industry drivers generating the interest in isolators in the last few years have been focused on improvements in process integrity. The security and effectiveness of isolators, operating in conjunction with sanitization techniques and transfer systems such as interlocking transfer ports, have been demonstrated to provide a more secure system than the traditional cleanrooms for this type of analytical work. Additional individual isolators are provided in which separate formulation and/or filling operations can be undertaken. Technical Considerations for the Design, Manufacture, and Testing of Isolators The susceptibility of the process to contamination is critical in terms of risk assessment. Alternative manipulation methods using tongs and remote manipulators can be of advantage in isolators, but currently are rarely found in pharmaceutical applications.
