ABSTRACT
Microbial control of pharmaceuticals is primarily concerned with minimizing the opportunities for drug products to be contaminated by microorganisms. Different types and levels of microbial control are applicable to different types of products. The pharmacopeial standard applying to sterile products is that they must be capable of passing a Test for Sterility. The Test for Sterility relies on the detection of viable microorganisms within a sample that is directly or indirectly inoculated into broad-spectrum microbiological recovery media. There was no indication in the pharmacopeias until 1955 in the US Pharmacopeia -and until 1968 in the British Pharmacopoeia that the results of the Test should be or could be extended to apply to batches of product required to be certified as sterile. However, with such a small sample size, successful results provide little assurance that there is not a significant proportion of contaminated units in the batch.
