Sterilization and Clean Rooms

Method selection, risk analysis, process characterization, equipment, product and process definition
• Validation
• Review, revalidation
• Release of the product from sterilization
• Conformity assessment – fulfillment of MDR requirements
• Standards applied in the area of sterilization
• Sterilization quality management system
• Requirements for clean rooms
• Monitoring of clean spaces
• Selection of packaging materials from the point of view of sterilization
• Properties of the microbial barrier in terms of sterilization
• Design and development of deep packaging from the point of view of sterilization
• Sampling plan, justification for the selection of suitable tests, criteria from the point of view of sterilization
• Proof of intactness of the sterile barrier system after sterilization and during the subsequent test of functionality from the point of view of sterilization
• The packaging process and its validation in terms of sterilization