Publisher's Synopsis
This clear and comprehensive description of the micro-organism as a contaminant and as a potential growth medium reveals the problems of microbiological control in pharmaceutic product design and manufacture. It is a uniquely extensive and fundamental review of the problems of preserving complex formulation against the microbial stresses imposed during manufacture and afterwards, often with only a limited range of permissible preservatives and often at a stage close to licence application when formulation changes are strongly resisted.;The authors, each invited for their particular expertise, underline the versatility of micro-organisms and the relative susceptibilities of product types and ingredients; the principles of factory hygiene, microbiological quality control and good manufacturing are considered as well as monitoring methods for microbiological quality. They establish the distinction between sterile and non-sterile products and the merits and demerits of available sterilization methods.
