Ensuring the safety and quality of products in the pharmaceutical industry relies heavily on effective sterilization processes. Validation of these processes is essential and detailed guidance on the development, validation and control of the application of sterilization processes is provided in the current edition of the ISO 17665 standard from 2024. In addition, the guidelines of the European Pharmacopoeia (Ph. Eur.) and the FDA must be observed.

It is crucial to clearly define and consider key parameters such as temperature, pressure and time specifically for different pharmaceutical products. A comprehensive risk analysis is essential and should be accompanied by protocols for the installation and operational qualification (IQ/OQ) of the sterilization system.
Learn more about the new features of ISO 17665 and the essential procedure for standard-compliant validation of steam sterilization processes in this presentation.