Validation et contrôle des procédés de stérilisation non-standards

With the upcoming abundance of sterilization techniques applied to various pharmaceutical product types, it has appeared useful to the committee to compile general guidelines for the proper mastery of this critical step of many pharmaceutical processes. Derived from the experience gained with conventional and more recent sterilization proccesses, this reports offers guidance for the definition of product sterility and the validation and control of the safety, reliability efficiency and proper operation of the non-standard sterilization processes.