Today’s user is often faced with the challenge of meeting several international standards and regulatory guidances as well as performing sampling for airborne particles in a consistent and reproducible manner.
International standards for the monitoring of airborne particles are used by all industries that employ cleanrooms or clean zones. Some form of airborne sampling for particles is needed for these controlled environments in order to assure the quality of the product being manufactured or the success of the process that is being conducted in this controlled or critical environment. Many variables will affect the success of the operations in these areas but the particulate levels in the air are often a significant element in the control of risk, or, inversely, the likelihood of success for the controlled operation.
Today’s environments—especially aseptic filling operations but also mini-environments and other specialty processes in electronics and aerospace—require consistent and reproducible results. The new calibration standards and recommended practices help with assuring the functionality of the particle counter but there needs to be a significant focus on the sampling methods and practices so that high quality data is obtained, and also so that the act of obtaining the sample does not compromise the process or product in the key areas.
Dynamic smoke studies can be extremely valuable to determine if the combination of airflow and activity will result in risky patterns of flow that could draw contamination into the critical zones. The potential value of high flow particle counters needs to be carefully weighed against the heightened risk of influencing airflow patterns. Perhaps new procedures need to be designed and implemented in your facility after reviewing smoke studies in order to maintain the quality and consistency of the air environment during activity.