Sterility is a key quality attribute for a class of medicines required to be sterile. The consequences of non-sterility are direct patient harm. The degree of harm is dependent upon the route of administration and the types and numbers of microorganisms, as well as the health and immune state of the patient. The likely outcomes of the administration of a non-sterile product are disability or death. For this reason, contamination control is of utmost importance for the manufacture of sterile products.
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