Advice for EU GMP 0.5 and 5.0 μm Particle Limits
There is a common industry misconception that 1 m3 particle monitoring should be performed. This requirement is not specifically stated in the regulations. Unfortunately, the original EU GMP text was not clear on this matter and frequently misinterpreted.
The guide is for continuous particle monitoring in Grade A and immediate Grade B areas using an in situ particle sensor 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 poses an even greater risk to the finished product.
Since we cannot control the risk, we must measure it. If it is in excess of proven acceptable limits, then the system must alert the users. How quickly the facility monitoring system alarm should alert the users, is dependent upon the risk. Analysis of risk can be considered as how resilient the filling operation is to potential contamination events while still able to protect product. If the system is very robust (i.e., Isolator, RABS) then an event has a relatively low risk of contamination. If it is an ampoule line with curtain protection then small deviations could have a greater impact. No answer will fit all applications as all risk is variable; considerations such as what gowns are used, what under garments are supplied, air changes / hour rate, number of personnel in room, and so forth are all important factors
Setting the alarm limits is important to assure quick response to events which exceed the proven acceptable limits. A guide for setting the alarm limits for in situ particle sensor such as the Airnet® II or IsoAir® 310P in Grade A and immediate Grade B cleanrooms is provided.
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