Regulatory bodies certainly want to ensure that medicines and biotech products are safe for consumers. To that end, they want to be sure that root causes are identified, with corrective and preventative actions put in place. And they want process improvements to provide an even higher level of safety in the future.
A facility monitoring system is a process monitoring tool that collects data from sensors called particle counters. Over time, as the reliability of particle counting instruments evolves, this creates opportunities to implement real-time quality control strategies. This leads to quality-based monitoring and immediate decision making to reliably produce high-quality drugs without excessive regulatory oversight.
Facility monitoring software with OPC UA client/server functionality makes great business sense. Reliable cleanroom monitoring leads to reduced product waste, improved yield, improved product quality, and increased profits. Only when critical data is collected from many sensors and turned into relevant information can better decision making take place — without compromising patient safety.
Discover how laser induced fluorescence (LIF) works and how it helps to detect viable particles in real time. In aseptic manufacturing, LIF shows great potential to replace growth-based methods in certain manufacturing paradigms — highly automated, near-continuous processes.
In GMP environments, proper risk assessment needs to be conducted. In those applications that use VHP gassing, usually Grade A environments, consideration must be given to particle counting during gassing cycles. Typically, a valve solution is used during the gassing cycle, at which time the FMS software can be configured to disable any potential nuisance alarms, while helping users to collect and report data.
Investigations of airborne viable excursions in cleanrooms using traditional techniques notoriously fail to identify a definitive root cause. What if this information were available in real time when the contamination event occurred? This video introduces real-time viable particle monitoring and how it can quickly identify the source of a contamination.