This application note will demonstrate how real-time viable particle count data will lead to improved root cause investigations when a BIOTRAK Particle Counter is integrated into an FMS system. Improved root cause investigations and the resulting increased process knowledge is in line with current regulatory initiatives and expectations.
In the Pharmaceutical industry, US FDA Aseptic Processing guidance 2004 and EU GMP Annex 1:2008 clearly requires continuous nonviable particle monitoring of aseptic manufacturing processes. This is in addition to the requirement to classify the particle cleanliness of clean zones. Monitoring systems may comprise many types of sensors including particle counters, like the TSI AEROTRAK™ Remote Particle Counters 7510-01F, positioned at critical locations throughout the manufacturing process. All sensors are connected to Facility Monitoring Software like TSI’s FMS which continuously collects data from these instruments. The principles of Quality Risk Management (ICH Q9) are used to help determine particle monitoring locations.
Continuous nonviable particle counting is an important measurement in critical areas and has historically been the only way to determine the particulate quality of the airborne environment of manufacturing spaces in real-time.