Microbiological and Particle Risk Assessment of a Cleanroom and Aseptic Filling Line Contamination
Filling Line Contamination can be generally avoided through an effective contamination monitoring system, starting with a risk assessment.
A theoretical case study involving the steps of classification, risk assessment and monitoring plan verification was conducted. The classification used total particle concentration and environmental monitoring data and established routine microbiological and particle monitoring points for an aseptic filling line. The cleanroom utilized Grade A, B, C and D zones.
