Advice for EU GMP 0.5 and 5.0 μm Particle Limits

Abstract

The EU GMP Annex 1 Guide requires continuous particle monitoring in Grade A and immediate Grade B areas using an in situ particle counting system, such as the Airnet II or IsoAir 310P. This is because the risk of contamination of finished product is very high and the greatest risk, the operator, is in close proximity. The operator is not only the greatest risk posed to product but also a random generator of those particles. These are not all inert particles; some will be viable, which pose an even greater risk to the finished aseptic product. Since we cannot control the risk, we must measure it, because “without measurement there is no control”

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