ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Tracer

Substance or microorganism used to measure the quantitative development of soiling. ISO 14698-3.

NOTE 1: In order to measure the efficiency of a process, the microorganisms which have developed within soiling, with or without formation of a biofilm, may be used as a tracer.

NOTE 2: Activities such as cleaning, rinsing, and biochemical or mechanical action eliminate soiling and biofilm by removal. The aim of disinfection is, by definition, to destroy or inactivate microorganisms. Consequently, it may be desirable to measure, in the overall efficiency of a process, that which may be attributed to the eliminative action, in order to distinguish this from the effect of the killing (destructive) action. To this end, one or more additional tracers may be chosen, whether naturally present in the soiling or to be added to it, that ere not liable to be destroyed.

Tracer

A radioactively labeled nucleic acid component included in a reassociation reaction in amounts too small to influence the progress of reaction.

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