ABSTRACT
Although terminal sterilization of injectable solutions was an established technical process by the 1920s, this was the period in which, arguably, the first injectable protein, insulin, became available. With very little to guide them, manufacturers very quickly discovered that it was necessary to prepare a sterile solution of the drug by filtration through porous ceramic filters, followed later by Seitz or compacted asbestos fiber filters. The sterilization process eventually became more controlled with the application of scientific measurements based on the response of selected, heat-resistant, microorganisms. The microbial death process was considered to be a kinetic process, requiring time to go to completion. This book deals with the laboratory techniques associated with aseptic processing and discusses some unique issues related to aseptic processing. The need for aseptic assembly of the product will continue to exist; all that remains is for the manufacturer to optimize conditions.
