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HES6417 Microbiological Aspects of Pharmaceutical Manufacturing (4 days)

Aims and Objectives

This unit aims to give students without a strong background in microbiology an introduction to the topic.

At the end of this unit, students will be able to:

• Demonstrate basic concepts of microbiology.
• Display practical skills and techniques required in microbiological analysis.
• Understand the fundamental concepts involved in pharmaceutical microbiology and its importance to the therapeutic goods industry.
• Understand the role and importance of microbiology in product safety and quality assurance issues.
• Relate the importance of laboratory records, raw data, traceability and documents to GMP compliance and regulatory inspections within a microbiology laboratory.
• State the importance of controls over media and other test parameters.
• Understand the relationship between microbial standards and product risks.
• Relate sterility assurance practices in the plant to sterile products and testing.

Content

Topics will be selected from the following:

• Microbiology and Good (Quality Control) Laboratory Practices.
• A survey of micro-organisms.
• Structure and function of bacterial cells.
• Nutrition and growth of bacteria, counting techniques.
• Control of microbial growth, sterilisation and disinfection.
• Role of micro-organisms in product spoilage.
• Pathogens and toxins, control methods, preservation methods.
• Water microbes.
• Viruses.
• Fermentation microbiology: manufacture of food, bioreactors.
• Related practical exercises.
• Mycoplasma.
• Validation of bioburden testing methods.
• Microbial testing pour plate method.
• Microbial filtration test method.
• Preparation and quality control of media.
• LAL and pyrogen test - validation and usage.
• Handling, quality control and use of biological indicators.
• Reporting of microbial test results.

Format

The course consists of a lively mix of presentations, group exercises, and discussions. At the end of the course, there will be a short quiz to test understanding. Copies of all presentation slides and handouts will be provided.

Out of Class Assignment

Participants are offered the opportunity to complete a GMP assignment following completion of the course. This will be facilitated and supported remotely by SeerPharma's team of consultants, and successful completion will be rewarded with additional certification.

There is no additional charge for this.