The European pharmaceutical industry is navigating a major transformation of its regulatory landscape—the full implementation of the new EU GMP Annex 1. At the heart of this new regulation is the establishment of a comprehensive "Contamination Control Strategy" (CCS), which emphasizes a scientific and risk-based approach. Particularly for Grade A aseptic core zones, the new rules mandate the systematic collection of a 1m³ air sample to obtain more representative environmental data. In this context, the 100 LPM (Liters Per Minute) flow-rate particle counter has transitioned from a "recommended option" to a "definitive choice" for ensuring compliance.
Using a traditional 1 CFM (28.3 LPM) instrument to complete a 1m³ sample takes over 35 minutes. In aseptic operations where every second counts, such a prolonged monitoring period significantly increases the risk of operator intervention and environmental exposure. Suzhou Sujing's 100LPM portable particle counter slashes this process to a mere 10 minutes. This translates to less production downtime, a lower risk of human-induced contamination, and the ability to gather more monitoring data within the same timeframe, providing a more robust foundation for trend analysis and risk assessment. It is not merely a tool for meeting regulatory text but a strategic asset that empowers European pharmaceutical firms to optimize their CCS and elevate their sterility assurance levels.
