(BQ) Part 2 book “Hugo and russell’s pharmaceutical microbiology” has contents: Pharmaceutical biotechnology, manufacture of antibiotics, factory and hospital hygiene, sterile pharmaceutical products, sterilization procedures and sterility assurance, and other contents. | Part 3 Microbiological Aspects of Pharmaceutical Processing Chapter 15 Ecology of microorganisms as it affects the pharmaceutical industry Elaine Underwood 1 Introduction 2 Atmosphere Microbial content Reduction of microbial count Compressed air 3 Water Raw or mains water Softened water Deionized or demineralized water Distilled water Water produced by reverse osmosis Distribution system Disinfection of water Chemical treatment Filtration Light Microbial checks 1 Introduction The microbiological quality of pharmaceutical products is influenced by the environment in which they are manufactured and by the materials used in their formulation. With the exception of preparations which are terminally sterilized in their final container, the microflora of the final product may represent the contaminants from the raw materials, from the equipment with which it was made, from the atmosphere, from the person operating the process or from the final container into which it was packed. Some of the contaminants may be pathogenic while others may grow even in the presence of preservatives and spoil the product. Any microorganisms that are destroyed by in-process heat treatment may still leave cell residues which may be toxic or pyrogenic (Chapter 3), as the pyrogenic fraction, lipid A, which is present in the cell wall is not destroyed under the same conditions as the organisms. 4 Skin and respiratory tract flora Microbial transfer from operators Hygiene and protective clothing 5 Raw materials 6 Packaging 7 Buildings Walls and ceilings Floors and drains Doors, windows and fittings 8 Equipment Pipelines Cleansing Disinfection and sterilization Microbial checks 9 Cleaning equipment and utensils 10 Further reading In parallel with improvements in manufacturing technology there have been developments in Good Manufacturing Practices to minimize contamination by a study of the ecology of
