Production of pharmaceuticals is a complex process which goes beyond the synthetic
reactions undertaken to produce the final drug product. In multi purpose
manufacturing facilities the equipment used in the processes must be proven to be
sufficiently free of residue from the previous compound so that safe manufacture of
the next compound can commence. Cross contamination can pose serious health risks
so cleaning verification is a process of extreme importance.
Pharmaceutical products may contain impurities that originate from the synthetic
stages of production, the starting materials or from in situ reactions taking place in the
final drug. Some of these impurities may be genotoxic. Genotoxic impurities are a
class of impurities for which awareness is currently growing in the pharmaceutical
industry.
Traditional analytical chemistry methods such as HPLC are currently employed for
the detection and quantification of cleaning residues and genotoxic impurities. These
methods can be extremely time consuming. The aims of this project are to investigate
swab sampling in cleaning verification, to develop alternative analytical methods
which speed up and enhance knowledge of the cleaning verification process and to
begin the development of an assay system for commonly occurring genotoxic
impurities
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