d50-VALUE: A CONVENIENT WAY TO COMPARE THE PHYSICAL COLLECTION EFFICIENCY OF MICROBIOLOGICAL AIR SAMPLERS AND A PRACTICAL APPROACH FOR THE VALIDATION
Authors:Hans Zingre, Beat Glauser
Keywords:d50-Value, impaction method, validation, microbiological air samplers, isolators, clean rooms
Abstract:The air in pharmaceutical production areas has to be monitored for microorganisms. International Standard ISO 14698-1/2' describes how to check for microbiological contamination and explains the principles and methods regarding these measurements.
In this paper the important parameters for the physical collection efficiency are introduced. With an easy mathematical formula they can be summarized into a single d50 value which can be used to compare different models of impaction based air samplers.
As most of the companies will not have access to a test chamber as required in the ISO 14698 a simplified approach to test the performance of any air sampler is described.
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