Rethinking Viable Air Monitoring: Insights from Quality by Design
In pharmaceutical manufacturing, environmental monitoring isn’t just a regulatory checkbox—it’s a cornerstone of product safety and process integrity. The “Quality by Design and Single-Use Air Sampling” paper from Particle Measuring Systems dives deep into the evolving landscape of viable air monitoring.
From the limitations of settle plates to the advantages of slit impaction technology and HEPA-filtered exhaust systems, this resource offers practical guidance on how to align your contamination control strategy with EU GMP Annex 1 and ISO 14698 standards. Whether you’re evaluating continuous monitoring in Grade B areas or exploring single-use solutions like the BioCapt® single use impactor, this paper helps you make informed decisions backed by science and regulation.