Microbial purity is an important parameter for pharmaceuticals, and not only for those that are deemed to be sterile. The risk of introduction and proliferation of microorganisms needs to be managed at all steps of the production process. This is done by appropriate hygiene measures to avoid contamination of the product during manufacturing as well as by testing for microbes at different production steps. A sound understanding of regulations, specific risks and the test methods are needed to smoothly integrate the microbiological topics into the site-specific contamination control strategy.
a solid understanding of the role of microbiology in the production process
to recognize and deal with microbiological risks and issues
the science and principles behind microbiological aspects in manufacturing and lab testing
integration of microbiology in site-specific contamination control strategy
and evaluate the data of microbiological test results