ABSTRACT
Of all the potential sources of microbiological and particle contamination in a sterile product manufacturing facility, people are the worst offenders. Therefore, anything that can be done to reduce contamination levels from people will improve the assurance of sterility of dosage forms prepared in the presence of people. Of course, the ultimate solution to eliminate this major source of contamination is to completely remove any contact of people with product being manufactured. Indeed, the advent of barrier isolators aims to do just that (chap. 23). Perhaps someday all sterile product filling will be accomplished using isolator systems, but until then, control of contamination from people will continue to be the greatest challenge in assuring product sterility.
