ABSTRACT
The use of standard sterilization technologies in modern pharmaceutical manufacturing processes is often limited. In this chapter, the use of alternative sterilization methods will be considered and a method of proving their suitability will be demonstrated. Whereas correlation of physical parameters with bacterial reduction is well established in standard sterilization technologies, such a correlation is currently neither generally recognized nor possible for alternative sterilization processes. Furthermore, there is a lack of information regarding basic data including process mechanisms, physical influences and boundaries, suitable test organisms, and qualification strategies. Consequently, the efficiency and reproducibility of alternative sterilization methods is difficult to validate in comparison to standard sterilization processes. Because of this, alternative sterilization methods are often confusedly discussed and are poorly accepted in pharmaceutical industries and by authorities.
