Chapter 8 Microbiological Control - Biomanufacturing

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2016 Montgomery County Community College Chapter 8 Microbiological Control 282 Chapter 8 - Microbiological Control Objectives This Chapter provides an overview of Microbiological Control in the Biomanufacturing industry. After completing this Chapter the student will be able to: Explain why Microbiological Control is important in a Biomanufacturing facility and provide a number of examples as to how it is achieved and maintained. Describe the various sources of microbial contamination within a Biomanufacturing facility/process and name specific microbial contaminants and their possible sources. Explain the different Microbiological cleanliness standards required for the manufacture of biopharmaceutical drug substances and drug products. Define aseptic processing and provide examples of aseptic processing practices. Identify measures taken in controlled and classified environments within cleanrooms to prevent microbial contamination.

As with food production, microbiological control is a key issue in pharmaceutical manufacturing. This is particularly true in the case of biopharmaceuticals and bioprocessing, which use various organic materials to create a range of products. Microbiological control is …

  Control, Microbiological, Control microbiological