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Regulatory
Risk analysis: myths, confusion and common sense
Cleanrooms expert Dr Alexander Fedotov, Invar-project, Moscow, Russia, gives his personal view on modern methods of risk analysis and calculating risk, as suggested in ICH Q9, and questions the practical value of its inclusion in the new EU GMP
Design & Build
Saving energy in cleanrooms
Cleanrooms consume large amounts of energy and it is common for power requirements to be specified based on norms without a clear understanding of the dynamics. Alexander Fedotov, Invar-project, considers steps to reduce energy consumption based on real examples and figures