ABSTRACT
This chapter addresses bioburden in a liquid product. Such organisms will be suspended in the solution as single cells or aggregates. Biofilms of organisms on manufacturing equipment and medical devices have been reviewed. The simplest and most effective way to detect organisms is the membrane filter version of the United States Pharmacopeia sterility test. There are multiple, human manipulations in this old version of the sterility test, and the possibility of inadvertent microbial contamination of the drug samples by a human operator is unacceptably high. In the various stages of drug production, control of the microbial population is necessary because microbes can metabolize the drug. Injured organisms include vegetative and spore forms of bacteria, fungi, and mycoplasmas damaged by heat, shear, pressure, chemicals, but are still integral and retain the capacity to carry out some metabolic functions, to rejuvenate, or both. The basic approaches to organism recovery from air are impaction into a solid medium and, impingement into liquid medium.
