Microbial Bioburden on Oral Solid Dosage Forms

Life first appeared on Earth in the form of bacteria-like organisms. Cellular fossils, recovered from rocks that have been dated to 3.5 billion years old, have been identified as prokaryotic cells (bacteria and cyanophytes) and stromatolites (mats of sediment trapped and glued together by prokaryotic cells in shallow marine waters) (1,2). For billions of years, bacterial life has remained the most common and most successful form of life on Earth. Some overzealous humans view microorganisms, and especially all bacteria, as alien foes that must be exterminated.However, sterility is an unnatural state on this planet, except for some areas of the human or animal body. From the ocean depths to the tallest mountains, from the coldest place in Antarctica to the hottest geyser in Yellowstone Park, microbial life is all around us.Whether we like it or not, this fact never will change.