ABSTRACT
Many have fallen into the trap of spending huge amounts of money building a cleanroom with little thought and understanding of what is required to get it up and running and the subsequent maintenance of it. It is vital, even at the start, to see that the design of the cleanroom, with regard to the contamination controls required speci©cally for the product that is to be manufactured within it, is exactly right. Too o¨en not enough time and thought are put into this initial phase with serious consequences with regard to cost of modifying or redesigning the facility and having protocols that cannot be e£ectively implemented. Validation of the cleanroom takes time, patience, and understanding to complete but is vital to get right the ©rst time. ¢is will ensure that the cleanroom is controlled from the start, that the process within the room is not posing a risk to the environment, that personnel working within the cleanroom are following protocol, and that products manufactured or processes performed within it will be consistently and reproducibly safe and of the highest quality. ¢e two main parts to consider when performing a cleanroom validation are certi©cation including classi©cation and measuring microbial contamination levels. Once validation has been completed, a comprehensive plan should be established for the routine monitoring and maintenance of the cleanroom. ¢is chapter discusses designing, validating, and monitoring of cleanrooms.
