Course Overview

Sterilization processes are performed in laboratories, hospitals and industries as the final processing step for preparation of safe critical materials and devices used in the Public Health sector and for pharmaceutical products, in order to preserve products and to ensure their expected shelf-life. A better understanding of sterilization processes (as the choice of sterilizing agent to be used, kinetic parameters determination and biological indicators application) can minimize misunderstandings related to contamination, production and/or processing of these pharmaceuticals devices.

Learning Achievement

This course aims to present the basic concepts and parameters related to sterilization and validation processes, which are responsible to guarantee consistent sterility levels required for obtaining pharmaceutical and medical products.

Competence

Course prerequisites

Grading Philosophy

Exercises and seminars.

Course schedule

1. Introduction_- Concepts and application of sterilization. 2. Kinetic parameters: Decimal reduction time (D-value), Relative resistance (z-value), Sterility Assurance Level, Process equivalent time (F value), Q10 parameter and activation energy. 3. Biological and chemical Indicators: main characteristics, types, applications and relationship. 4. Sterilizing agents: Physical, chemical and gaseous agents. 5. Validation processes: definitions and legislation, qualification of installation, operating system qualification_and physical and biological validation. Practical: Application of biological indicators, determination of kinetic parameters

Course type

Online Course Requirement

Instructor

Marina Ishii

Other information

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