Temple University 3 credits QARA
A study of the theory and application of sterilization processes in the preparation of sterile pharmaceutical products. The course will cover basic principles and current sterilization technology. The course will focus on moist heat sterilization using autoclaves which is the predominant sterilization method employed in the production of pharmaceuticals. A case study will be used in the course demonstrating the specification, installation, qualification and regulatory approval of a new autoclave facility. An overview of gas and radiation sterilization will be provided. Specific pharmaceutical product examples using radiation and gas sterilization will be reviewed in detail. Not open to students who have completed QARA 0493.
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