Drug manufacturers are increasingly concerned about the sources of potential contamination from processing equipment. To give a sense of the scale of this problem, 15% of drug recalls reported by the US Food and Drug Administration (FDA) in the last six months were due to contamination from processing equipment.
A primary area of concern is the direct contact of plastic processing materials that comprise single-use components with the drug product. It is widely known that this can result in the presence of compounds, which may affect efficacy, safety or quality.
For manufacturers working on a multi-million dollar drug trials and treatments, the implications of this from a product development and brand integrity perspective are significant.
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