Requirements for Smoke Studies in Cleanroom Technology

In this practical-oriented seminar, professionals and managers will learn how to implement Smoke Studies efficiently and in compliance with regulations in cleanrooms. Building on the requirements of EU-GMP Annex 1 and other regulatory guidelines from EMA, PIC/S, and FDA, participants will learn to recognize contamination pathways, assess critical process steps through risk analyses, and derive appropriate measures for risk control.

In addition to the theoretical teaching of contamination control strategies, the use and added value of CFD simulations will be explained, and a practical workshop will demonstrate how to conduct a Smoke Study in a cleanroom. The focus will be on planning, documentation, and interpretation of deviations.

Furthermore, the seminar will cover the targeted use of Smoke Studies in the regulatory context, including the expectations of clients, required documentation, time investment, costs, and project phases. The seminar will conclude with practical content on environmental monitoring, microbiological qualification according to Annex 1, and handling deviations.

After the seminar, participants will be able to conduct Smoke Studies practically, efficiently, and in compliance with regulatory requirements, and to professionally document the results.