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Real-time PCR detection of S. aureus in pharmaceutical products

The contamination of pharmaceuticals by microorganisms represents a major threat to public health, not just in the USA and Europe, but all around the world. Pathogenic microorganisms cause morbidity and in some cases mortality when present in products.1,2 Spoilage due to microbial breakdown of formulations can affect potency and shelf life, yet non-sterile pharmaceuticals contain a microbial bioburden that is not detrimental to the formulation or hazardous to consumers.

Based upon compendial tests, when non-sterile pharmaceuticals are tested, objectionable microorganisms must be absent from the finished product and raw materials.1,2 For this reason, regulatory agencies around the world require the absence of certain types of microorganisms that can be considered hazardous to consumers or compromise drug stability and efficacy. Staphylococcus aureus is one of the indicator microorganisms that must be absent from non-sterile pharmaceutical drugs; however, based upon published scientific surveys, S. aureus is a frequent microbial contaminant in both sterile and non-sterile pharmaceutical products around the world.1-3 Furthermore, infections by S. aureus are the number one cause of nosocomial outbreaks in the USA,4 while common infections by S. aureus are related to skin eruptions, bacteremia, endocarditis, toxic shock syndrome and pneumonia.5 S. aureus is also characterised by the ability to develop resistance to almost any antibiotic.

The challenge for pharmaceutical manufacturers is to produce a non-sterile drug with low levels of microorganisms and a complete absence of the ‘wrong type’ of objectionable microbes.

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