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Objectionable organisms in non-sterile medicinal products

Microbiological contamination of non-sterile medicinal products is an infrequent, but longstanding and recurring issue. But there is no ‘one size fits all’ approach towards objectionable organisms, says David Elder…

A RECENT survey of US product recalls indicated that objectionable organisms were implicated in nearly 75% of all cases of microbial contamination.1 However, the issue facing manufacturers is unique as there are no universally agreed definitions for objectionable organisms. Sutton defined them as: “Objectionable in view of the product’s intended use and for products not required to be sterile.”2 This caveat is important, as all viable microorganisms must, by definition, be excluded from sterile products.

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