The challenge of isolating, characterising, and identifying the diminishingly small

摘要

Despite advances in cleanroom technology, it is impossible to completely exclude all contaminants from a production line or product. With appropriate controls and preventive measures, fortunately, most of the time it is possible to keep the levels of physical contaminants at acceptably low levels. When contamination is discovered it is vital to quickly determine its composition and characteristics. This is essential in evaluating whether the contaminant is harmful as part of a risk assessment, which may dictate that a batch must be scrapped, or a product be recalled. It is also the primary step in identifying the source of contamination and the root cause of any contamination incident, so that measures can be put in place to prevent re-occurrence.