Combining Particle and Microbial Sensors to Fully Meet Regulatory Requirements FAQ
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.
According to USP 797, critical areas must continuously meet ISO Class 5 or better conditions for 0.5 μm particles, and must exclude microbial contamination during the compounding of CSP’s. These classifications ensure that a designated zone is maintained in a clean state. The monitoring program is designed based on contamination risk to finished product quality.