The new ubiquitous term in aseptic manufacturing - Contamination Control Strategy

The meaning behind the term Contamination Control refers to a complex system of measures designed to minimise the risk of contamination during the manufacture of medicinal products. It comprises the primary measures - from a coherent zone concept for the relevant rooms, their maintenance and servicing, to requalification, cleaning and disinfection measures (see CRT "Disinfection of cleanrooms", 2017), requirements for personnel hygiene and behaviour, to the use of qualified consumables. But in addition to these basics, a strategy also includes the necessary control measures, such as the monitoring of rooms, surfaces and personnel to record and evaluate the respective condition.

Particularly in the evaluation and interpretation of environmental monitoring data, there are often still considerable deficiencies. The article by Raphy Bar and Axel Schroeder, which was recently published, deals with this topic: "Environmental monitoring: From sampling plan to data analysis".

The ECA Academy's "Contamination Control" course in Barcelona, Spain, from 20-22 November provides an overview of the topics relevant to successful contamination control.