Microbial bioburden on oral solid dosage forms

Abstract

Most pharmaceutical companies test oral solid dosage forms for microbial bioburden on a routine basis. However, routine testing of many products is not necessary because the low water activity of these products will not promote the proliferation of microorganisms. Furthermore, various manufacturing processes for oral solid dosage forms create hostile environments for microorganisms. Pharmaceutical manufacturing processes are designed to prevent objectionable microorganisms in drug products not required to be sterile. Hence, it is expected that oral solid dosage forms will have a natural microbial load of nonobjectionable microorganisms.