BMB528: Pharmaceutical Microbiology

The course introduces to pharmaceutical microbiology covering the fundamentals of microbiology and microbiological techniques with special focus on pharmaceutically relevant issues (hygiene, preservation, disinfection, sterilization) and requirements of the European Pharmacopoeia (Ph.Eur.). 

The course builds on the knowledge acquired in the courses FA508 and gives an academic basis for studying the courses in Drug Formulation and Production (FA511, FA503 and FA504), which are mandatory in the pharmacy bachelor education. 

At the end of the course the students will have gained knowledge about the most important aspects of pharmaceutical microbiology, especially the following aspects: 

• The sterilization and control of microbial contamination during the production of medicines.
• Microorganisms and the infections.
• Control of microbes in terms of patient treatment as well as in the environment.
• Understand the relevance of microbiology with respect to drug production and the microbiological quality of medicines according to the European Pharmacopoeia (Ph.Eur.)
• Know how to control and reduce the microbial burden in drug formulation and production.
• Understand the effects of physical and chemical agents on microorganisms. 

Together with practical experiences, students are expected to be competent to: 

• Investigate microorganisms by microscopic techniques. 
• Work in the laboratory under sterile conditions. 
• Use and understand the growth conditions for bacteria. 
• Determine the level microbial/contamination content of a given environment (such as air and water), or in a given drug. 

After completing the course, students should be able to:

• Describe the structure and molecular components of bacterial cells, viruses, and protozoa. 
• Understand the role of microorganisms in health and infection (pathogenic and non-pathogenic microorganisms) 
• Have knowledge of up-to-date microbial identification methods in pharmaceutical analysis. 
• Explain the role of hygiene in drug production, to ensure the microbiological quality of medicines and how and microbes give rise to contaminations. 
• Describe methods to control and reduce the microbiological burden (preservation, disinfection, sterilization). 
• Understand the effect of physical and chemical agents on microorganisms.
• Know general microbiological methods and requirements on microbiological quality of drug products described in the European Pharmacopoeia (Ph.Eur.) 

• Microbial growth
• Cell structure and function
• Microorganisms with respect to human health and infection 
• Detection and identification of microorganisms
• Microorganisms and drug production: Hygiene, disinfection and preservation 
• Sterilization methods according to the European Pharmacopoeia (Ph.Eur.) 
• Requirements on the microbiological quality of pharmaceutical products (Ph.Eur.) 
• Microbiological methods including those described in the European Pharmacopoeia (Ph.Eur.) 

• Intro phase (lectures) - 14 hours
• Training phase: 27 hours
• Studyphase: 85 hours

There will be a close correlation between the preparation of the theoretical assignment in the study phase and the training phase. There will therefore be ample opportunity to get guidance on the preparation of assignments as part of the training phase. In addition, a written report is prepared during the study phase as part of the completion of the laboratory work.

Activities during the studyphase:

• Curriculum reading
• Completion of theoretical assignments
• Writing a report in groups of 2