Combining Particle and Microbial Sensors to Fully Meet Regulatory Requirements FAQ
Understanding and preventing Particle Loss in Tubing can have notable results in contamination control.
Particle counters are used in a broad range of applications including cleanroom and clean air device classification in accordance with specified standards, testing of filter installation, portable environmental monitoring programs, in-situ environmental monitoring systems, and the fault diagnosis of specific processes. Historically, there has been a single volume flow rate of 1 CFM (28.3 LPM) chosen for many of these applications.
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.