Part 2: Microbiology and Control Technologies
By Edward G. Helmig
There are seven types of microbial organisms, subunits, and macromolecules of primary interest in the pharmaceutical business. These are summarized in Table A. Bacteria, pyrogens, and endotoxins are the main focuses of WFI systems. It is important to gain an understanding of exactly what an endotoxin is and why gram-negative bacteria are considered the primary source of endotoxins in pharmaceutical water systems. There are two basic types of microbial cells: prokaryotes and eukaroytes. The structures of the two cell types differ greatly. Prokaryotes consist of two domains of life: bacteria and Archae, and within this group we have anaerobes and aerobes. Topics within the article include ozone, Purified Water, sanitization, steam, sterilization, and UV.
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