Background

Clean-room design has developed considerably over recent years, and in particular to meet the requirements for a high-quality contained environment, not only for the pharmaceutical industry, but also for the nuclear energy and electronics/microchip industries. The demand for good-quality clean rooms has led to the development of a multitude of specialist companies and products catering for the need for specialist methods of construction, and the exacting regulatory requirements for room finishes and components.

With the growth in increasingly biologically active drugs and the development of biotechnology, more onerous and exacting requirements are now applied by the various regulatory authorities. At the same time, room construction and finishes are becoming ever more sophisticated and expensive, making industry all too aware of the spiraling costs of clean rooms. Methods of combating rising costs have already been introduced. A good example is the series of Baseline Guides developed by the International Society For Pharmaceutical Engineering (ISPE) in cooperation with the U.S. Food and Drug Administration (FDA). These guides are aimed at setting the minimum standards for a fit-for-purpose design, which will still comply with regulatory criteria.

In addition, the introduction of barrier technology means that the standards for background clean rooms can be rationalized, due to the totally contained approach. Cost benefits gained must be balanced against the cost of the isolator equipment, which is expensive.

There is also another approach, which limits the size of the clean room: having an efficient layout, and minimizing the room area by removing all activities and equipment not essential to the process to an adjacent but lower-quality space. The smaller the volume of the high-quality finished and highly serviced room, the less expensive it becomes.

The clean room classifications used in this chapter are those of the International Organization for Standardization (ISO) and in particular ISO 14644-1.

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