Contamination control strategy (2 ETCS): CCS and QRM
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The course has a duration of 1500 h equivalent to 60 ETCS. Each ETCS corresponds to 25 hours which will be assigned to lessons, practical exercises, group work, seminars, study and research activities for writing the thesis and individual preparation.
Lesson are mainly given in English:
General microbiology (2 ETCS): The microorganisms and their microscopic observation. Morphology and structure of bacteria. Bacterial replication. Bacterial genetics. Viruses. Fungi.
Applied microbiology (2 ETCS): Cultivation and enumeration of microorganisms. The origin of products contamination.
Sterility and rules (1 ETCS): Pharmacopeia; HACCP; ISO.
Steam sterilization (3 ETCS): Principles, equipment and process validation;
Gamma radiation sterilization (1 ETCS): Principles, equipment and process validation.
Sterilizing filtration (1 ETCS): Principles, equipment, process validation.
Chemical based sterilization (1 ETCS): Principles, equipment, process validation.
Sterility tests and method sensitivity (2 ETCS): Compendial and non-compendial assays, accuracy, precision and sensitivity
Materials/Processes compatibility (2 ETCS): Materials and process suitability. Material characterizations
Sterilization of nanomedicines (1 ETCS): Nanomaterials properties and process suitability
Automation and Robotics (2 ETCS): Basic of robotics and application to processes.
Contamination control strategy (2 ETCS): CCS and QRM